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Transcranial Magnetic Stimulation and Mental Representation Techniques for the Treatment of Stroke Patients

Primary Purpose

Stroke

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation (rTMS)
Motor Imagery (MI) through a Brain-Computer Interface (BCI) training platform in Virtual Reality (VR) with NeuRow
Sponsored by
Universidad Francisco de Vitoria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, rTMS, Motor Imagery, BCI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Older than 18 years old.

Ischemic or hemorrhagic cerebrovascular injury diagnosed by a neurologist and who have at least one brain-imaging test.

Onset of hemispheric ischemic or hemorrhagic stroke> 3 months <12 months.

Sufficient cognitive ability to understand and perform tasks: Token Test> 11

Kinesthetic and Visual Imagery Questionnaire (KVIQ)> 55.

Stability in antispastic medication for more than 5 days

Fugl-Meyer Assessment for upper extremity (FMA-UE) >25.

Able to read and write

Exclusion Criteria:

History of seizure or brain

Pacemakers, medication pumps, metal implants in the head (except dental implants)

Clinical unstability

Muscle tone in the wrist and elbow with a modified Ashworth scale (MAS) score equal or higher than 3

Other pre-existing neurological diseases or previous cerebrovascular accidents with sequelae.

Sensory aphasia

Previous TMS after stroke

Hemispatial neglect, (Bells Test> 6 omissions on one side)

Flaccid paralysis Brunnstrom's stage = 1

Visual problems

Sites / Locations

  • Hospital Beata Maria Ana

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bilateral rTMS combined with MI through a BCI training platform in VR with NeuRow

Repetitive TMS in bilateral cortical primary motor area

Arm Description

Sequential active rTMS at low frequency (healthy hemisphere) and high-frequency (injured hemisphere) application during 10 sessions in two weeks, and Motor Imagery (MI) treatment through the BCI training paradigm in VR (NeuRow) for 12 sessions in four weeks (3 sessions a week).The first 6 MI-neurofeedback sessions will carry out after bilateral stimulation with rTMS (i.e., rTMS as a priming method during the first two weeks), and the last 6 sessions, without rTMS as prior priming during the last two weeks

Sequential active rTMS at low frequency (healthy hemisphere) and high-frequency (injured hemisphere) application during 10 sessions in two weeks.

Outcomes

Primary Outcome Measures

Change in Dynamometry
A handheld analogic dynamometer (Jamar® Plus+ Hand Dynamometer, 0-90 kg) will be used to assess isometric grip strength. Patients will be positioned in a straight back chair with both feet on the floor and the forearm resting on a stable surface. Each patient will be instructed to assume a position of adducted and neutrally rotated shoulder. For the arm to be tested, the elbow was flexed to 90º, the forearm and wrist will be in neutral positions, and the fingers will be flexed as needed for a maximal contraction. Patients will perform a maximal isometric grip contraction until they reach maximal force output. Three measures will be taken with 1-minute rest between test, and the mean value will be recorded
Change in Dynamometry
A handheld analogic dynamometer (Jamar® Plus+ Hand Dynamometer, 0-90 kg) will be used to assess isometric grip strength. Patients will be positioned in a straight back chair with both feet on the floor and the forearm resting on a stable surface. Each patient will be instructed to assume a position of adducted and neutrally rotated shoulder. For the arm to be tested, the elbow was flexed to 90º, the forearm and wrist will be in neutral positions, and the fingers will be flexed as needed for a maximal contraction. Patients will perform a maximal isometric grip contraction until they reach maximal force output. Three measures will be taken with 1-minute rest between test, and the mean value will be recorded
Change in Dynamometry
A handheld analogic dynamometer (Jamar® Plus+ Hand Dynamometer, 0-90 kg) will be used to assess isometric grip strength. Patients will be positioned in a straight back chair with both feet on the floor and the forearm resting on a stable surface. Each patient will be instructed to assume a position of adducted and neutrally rotated shoulder. For the arm to be tested, the elbow was flexed to 90º, the forearm and wrist will be in neutral positions, and the fingers will be flexed as needed for a maximal contraction. Patients will perform a maximal isometric grip contraction until they reach maximal force output. Three measures will be taken with 1-minute rest between test, and the mean value will be recorded
Change in Dynamometry
A handheld analogic dynamometer (Jamar® Plus+ Hand Dynamometer, 0-90 kg) will be used to assess isometric grip strength. Patients will be positioned in a straight back chair with both feet on the floor and the forearm resting on a stable surface. Each patient will be instructed to assume a position of adducted and neutrally rotated shoulder. For the arm to be tested, the elbow was flexed to 90º, the forearm and wrist will be in neutral positions, and the fingers will be flexed as needed for a maximal contraction. Patients will perform a maximal isometric grip contraction until they reach maximal force output. Three measures will be taken with 1-minute rest between test, and the mean value will be recorded
Change in Fugl-Meyer Assessment for upper extremity score
It is an observational rating scale that assesses sensorimotor impairments in post-stroke patients. It also includes four subscales: A. Upper Extremity (0-36), B. Wrist (0-10), C. Hand (0-14), D. Coordination/Speed (0-6) composing a total maximum score of 66 points. The therapist will rate each item according to direct observation of the motor performance, using a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, and 2 = performs fully) with lower scores indicating more impairments. The FMA is easy to use and has excellent validity, reliability, and responsiveness.
Change in Fugl-Meyer Assessment for upper extremity score
It is an observational rating scale that assesses sensorimotor impairments in post-stroke patients. It also includes four subscales: A. Upper Extremity (0-36), B. Wrist (0-10), C. Hand (0-14), D. Coordination/Speed (0-6) composing a total maximum score of 66 points. The therapist will rate each item according to direct observation of the motor performance, using a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, and 2 = performs fully) with lower scores indicating more impairments. The FMA is easy to use and has excellent validity, reliability, and responsiveness.
Change in Fugl-Meyer Assessment for upper extremity score
It is an observational rating scale that assesses sensorimotor impairments in post-stroke patients. It also includes four subscales: A. Upper Extremity (0-36), B. Wrist (0-10), C. Hand (0-14), D. Coordination/Speed (0-6) composing a total maximum score of 66 points. The therapist will rate each item according to direct observation of the motor performance, using a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, and 2 = performs fully) with lower scores indicating more impairments. The FMA is easy to use and has excellent validity, reliability, and responsiveness.
Change in Fugl-Meyer Assessment for upper extremity score
It is an observational rating scale that assesses sensorimotor impairments in post-stroke patients. It also includes four subscales: A. Upper Extremity (0-36), B. Wrist (0-10), C. Hand (0-14), D. Coordination/Speed (0-6) composing a total maximum score of 66 points. The therapist will rate each item according to direct observation of the motor performance, using a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, and 2 = performs fully) with lower scores indicating more impairments. The FMA is easy to use and has excellent validity, reliability, and responsiveness.
Change in Stroke Impact Scale score
It is a stroke-specific quality of life instrument to assess the consequences of stroke and to determine the quality of life improvement after stroke rehabilitation. It presents 4 subscales, but only hand function domain will be evaluated. Lower scores indicate more impairment in quality of life. The Minimal Detectable Change (MDC) and Clinically Important Difference (CID) of the hand function subscale are 25.9 and 17.8 points, respectively.
Change in Stroke Impact Scale score
It is a stroke-specific quality of life instrument to assess the consequences of stroke and to determine the quality of life improvement after stroke rehabilitation. It presents 4 subscales, but only hand function domain will be evaluated. Lower scores indicate more impairment in quality of life. The Minimal Detectable Change (MDC) and Clinically Important Difference (CID) of the hand function subscale are 25.9 and 17.8 points, respectively.
Change in Stroke Impact Scale score
It is a stroke-specific quality of life instrument to assess the consequences of stroke and to determine the quality of life improvement after stroke rehabilitation. It presents 4 subscales, but only hand function domain will be evaluated. Lower scores indicate more impairment in quality of life. The Minimal Detectable Change (MDC) and Clinically Important Difference (CID) of the hand function subscale are 25.9 and 17.8 points, respectively.
Change in Stroke Impact Scale score
It is a stroke-specific quality of life instrument to assess the consequences of stroke and to determine the quality of life improvement after stroke rehabilitation. It presents 4 subscales, but only hand function domain will be evaluated. Lower scores indicate more impairment in quality of life. The Minimal Detectable Change (MDC) and Clinically Important Difference (CID) of the hand function subscale are 25.9 and 17.8 points, respectively.
Change in Motricity Index of the Arm
The upper limb section of the MI assesses muscle strength in 3 muscle groups, including grip, elbow flexion, and shoulder separation. Each movement is scored discreetly (0 if there is no movement, 9 if the movement is palpable, 14 if the movement is visible, 19 if the movement is against gravity, 25 if the movement is against resistance and 33 if the movement is normal ), obtaining a total score for the upper limb that ranges from 0 (severely affected) to 100 (normal). This assessment methodology has been widely used in rehabilitation progress evaluation and counts with a normalized and weighted scoring system.
Change in Motricity Index of the Arm
The upper limb section of the MI assesses muscle strength in 3 muscle groups, including grip, elbow flexion, and shoulder separation. Each movement is scored discreetly (0 if there is no movement, 9 if the movement is palpable, 14 if the movement is visible, 19 if the movement is against gravity, 25 if the movement is against resistance and 33 if the movement is normal ), obtaining a total score for the upper limb that ranges from 0 (severely affected) to 100 (normal). This assessment methodology has been widely used in rehabilitation progress evaluation and counts with a normalized and weighted scoring system.
Change in Motricity Index of the Arm
The upper limb section of the MI assesses muscle strength in 3 muscle groups, including grip, elbow flexion, and shoulder separation. Each movement is scored discreetly (0 if there is no movement, 9 if the movement is palpable, 14 if the movement is visible, 19 if the movement is against gravity, 25 if the movement is against resistance and 33 if the movement is normal ), obtaining a total score for the upper limb that ranges from 0 (severely affected) to 100 (normal). This assessment methodology has been widely used in rehabilitation progress evaluation and counts with a normalized and weighted scoring system.
Change in Motricity Index of the Arm
The upper limb section of the MI assesses muscle strength in 3 muscle groups, including grip, elbow flexion, and shoulder separation. Each movement is scored discreetly (0 if there is no movement, 9 if the movement is palpable, 14 if the movement is visible, 19 if the movement is against gravity, 25 if the movement is against resistance and 33 if the movement is normal ), obtaining a total score for the upper limb that ranges from 0 (severely affected) to 100 (normal). This assessment methodology has been widely used in rehabilitation progress evaluation and counts with a normalized and weighted scoring system.

Secondary Outcome Measures

Change in Electroencephalogram data
Mu (μ) is a type of rhythm in which α frequency can be found in sensorimotor cortex. Its changes are related with movement. M1 Mu (μ) rhythms will be assessed to evaluate changes in cortical function. They have been shown to be very useful in evaluating stroke patients recovery.
Change in Electroencephalogram data
Mu (μ) is a type of rhythm in which α frequency can be found in sensorimotor cortex. Its changes are related with movement. M1 Mu (μ) rhythms will be assessed to evaluate changes in cortical function. They have been shown to be very useful in evaluating stroke patients recovery.
Change in Electroencephalogram data
Mu (μ) is a type of rhythm in which α frequency can be found in sensorimotor cortex. Its changes are related with movement. M1 Mu (μ) rhythms will be assessed to evaluate changes in cortical function. They have been shown to be very useful in evaluating stroke patients recovery.
Change in Electroencephalogram data
Mu (μ) is a type of rhythm in which α frequency can be found in sensorimotor cortex. Its changes are related with movement. M1 Mu (μ) rhythms will be assessed to evaluate changes in cortical function. They have been shown to be very useful in evaluating stroke patients recovery.
Change in Nottingham Sensory Assessment (NSA)
Nottingham Sensory Assessment (NSA): Somatosensory impairment of the upper limb occurs in approximately 50% of adults after stroke, associated with loss of hand motor function, activity, and participation. The measurement of sensory impairment in the upper limb is a component of rehabilitation that contributes to the selection of sensorimotor techniques that optimize recovery and provide a prognostic estimate of the function of the affected upper limb.There are studies documenting changes produced in the sensation of the upper limb after the application of neurofeedback, and even after the intervention with motor imagery. Since the protocol presents an intervention with the application of these techniques, it is possible that there will be changes related to the sensitivity after the use of the platform, Neurow system (NeuroRehabLab, Lisbon, Portugal).
Change in Nottingham Sensory Assessment (NSA)
Nottingham Sensory Assessment (NSA): Somatosensory impairment of the upper limb occurs in approximately 50% of adults after stroke, associated with loss of hand motor function, activity, and participation. The measurement of sensory impairment in the upper limb is a component of rehabilitation that contributes to the selection of sensorimotor techniques that optimize recovery and provide a prognostic estimate of the function of the affected upper limb.There are studies documenting changes produced in the sensation of the upper limb after the application of neurofeedback, and even after the intervention with motor imagery. Since the protocol presents an intervention with the application of these techniques, it is possible that there will be changes related to the sensitivity after the use of the platform, Neurow system (NeuroRehabLab, Lisbon, Portugal).
Change in Nottingham Sensory Assessment (NSA)
Nottingham Sensory Assessment (NSA): Somatosensory impairment of the upper limb occurs in approximately 50% of adults after stroke, associated with loss of hand motor function, activity, and participation. The measurement of sensory impairment in the upper limb is a component of rehabilitation that contributes to the selection of sensorimotor techniques that optimize recovery and provide a prognostic estimate of the function of the affected upper limb.There are studies documenting changes produced in the sensation of the upper limb after the application of neurofeedback, and even after the intervention with motor imagery. Since the protocol presents an intervention with the application of these techniques, it is possible that there will be changes related to the sensitivity after the use of the platform, Neurow system (NeuroRehabLab, Lisbon, Portugal).
Change in Finger Tapping Task
It measures motor function and is very sensitive to the slowing down of responses. In this task, following the Strauss application norms, the participants will be instructed to press the space-bar on the keyboard as fast as possible and repeatedly with the index finger. Five 10-second attempts will be performed with the dominant hand. The average time between two consecutive taps in the five trials will be the dependent variable.
Change in Finger Tapping Task
It measures motor function and is very sensitive to the slowing down of responses. In this task, following the Strauss application norms, the participants will be instructed to press the space-bar on the keyboard as fast as possible and repeatedly with the index finger. Five 10-second attempts will be performed with the dominant hand. The average time between two consecutive taps in the five trials will be the dependent variable.
Change in Finger Tapping Task
It measures motor function and is very sensitive to the slowing down of responses. In this task, following the Strauss application norms, the participants will be instructed to press the space-bar on the keyboard as fast as possible and repeatedly with the index finger. Five 10-second attempts will be performed with the dominant hand. The average time between two consecutive taps in the five trials will be the dependent variable.
Change in Nine Hole Peg Test
It evaluates the impairment in upper limb dexterity. Patients must pick up as quick as possible, nine pegs from a container one-by-one unimanually and transfer them into a target pegboard with nine holes until filled. Then, they must return them unimanually to the container. The outcome variable will be the time spent to complete the whole task. This test is considered reliable, valid, and sensitive to change, among stroke patients.
Change in Nine Hole Peg Test
It evaluates the impairment in upper limb dexterity. Patients must pick up as quick as possible, nine pegs from a container one-by-one unimanually and transfer them into a target pegboard with nine holes until filled. Then, they must return them unimanually to the container. The outcome variable will be the time spent to complete the whole task. This test is considered reliable, valid, and sensitive to change, among stroke patients.
Change in Nine Hole Peg Test
It evaluates the impairment in upper limb dexterity. Patients must pick up as quick as possible, nine pegs from a container one-by-one unimanually and transfer them into a target pegboard with nine holes until filled. Then, they must return them unimanually to the container. The outcome variable will be the time spent to complete the whole task. This test is considered reliable, valid, and sensitive to change, among stroke patients.
Change in Modified Ashworth Scale score
Patients will be in the supine position with their arms by their side and with their head in neutral position. Wrist and elbow muscles resistance will be assessed during two repetitions of a passive motion within one second and measured on the following scale: 0 = no increased resistance; 1 = slightly increase resistance (at the end of the range of motion); 1+ = slightly increase resistance (less than half of the range of motion); 2 = clear resistance (most of the range of motion); 3 = strong resistance; 4 = rigid flexion or extension. It is markedly responsive in detecting the changes in muscle tone in patients with stroke and its minimal clinically important difference of effect sizes 0.5 and 0.8 standard deviations for the upper extremity muscles are 0.48 and 0.76, respectively.
Change in Modified Ashworth Scale score
Patients will be in the supine position with their arms by their side and with their head in neutral position. Wrist and elbow muscles resistance will be assessed during two repetitions of a passive motion within one second and measured on the following scale: 0 = no increased resistance; 1 = slightly increase resistance (at the end of the range of motion); 1+ = slightly increase resistance (less than half of the range of motion); 2 = clear resistance (most of the range of motion); 3 = strong resistance; 4 = rigid flexion or extension. It is markedly responsive in detecting the changes in muscle tone in patients with stroke and its minimal clinically important difference of effect sizes 0.5 and 0.8 standard deviations for the upper extremity muscles are 0.48 and 0.76, respectively.
Change in Modified Ashworth Scale score
Patients will be in the supine position with their arms by their side and with their head in neutral position. Wrist and elbow muscles resistance will be assessed during two repetitions of a passive motion within one second and measured on the following scale: 0 = no increased resistance; 1 = slightly increase resistance (at the end of the range of motion); 1+ = slightly increase resistance (less than half of the range of motion); 2 = clear resistance (most of the range of motion); 3 = strong resistance; 4 = rigid flexion or extension. It is markedly responsive in detecting the changes in muscle tone in patients with stroke and its minimal clinically important difference of effect sizes 0.5 and 0.8 standard deviations for the upper extremity muscles are 0.48 and 0.76, respectively.
Change in TMS Resting Motor Threshold (RMT) and cortical silent period (CSP)
In the first dorsal interosseous muscle or the abductor pollicis brevis muscle will be recorded to determine the cortical excitability changes and correlate them with the clinical outcomes.
Change in TMS Resting Motor Threshold (RMT)and cortical silent period (CSP)
In the first dorsal interosseous muscle or the abductor pollicis brevis muscle will be recorded to determine the cortical excitability changes and correlate them with the clinical outcomes.
Change in TMS Resting Motor Threshold (RMT)and cortical silent period (CSP)
In the first dorsal interosseous muscle or the abductor pollicis brevis muscle will be recorded to determine the cortical excitability changes and correlate them with the clinical outcomes.
Change in TMS Resting Motor Threshold (RMT) and cortical silent period (CSP)
In the first dorsal interosseous muscle or the abductor pollicis brevis muscle will be recorded to determine the cortical excitability changes and correlate them with the clinical outcomes.
Change in Barthel Index(BI)
Accurately assessing the ADLs of stroke patients greatly helps in evaluating the efficacy of stroke treatments. The Barthel Index was originally established to assess ADL in stroke patients and has been used extensively for this purpose.
Change in Barthel Index(BI)
Accurately assessing the ADLs of stroke patients greatly helps in evaluating the efficacy of stroke treatments. The Barthel Index was originally established to assess ADL in stroke patients and has been used extensively for this purpose.
Change in Barthel Index(BI)
Accurately assessing the ADLs of stroke patients greatly helps in evaluating the efficacy of stroke treatments. The Barthel Index was originally established to assess ADL in stroke patients and has been used extensively for this purpose.

Full Information

First Posted
March 22, 2021
Last Updated
May 2, 2023
Sponsor
Universidad Francisco de Vitoria
Collaborators
Hospital Beata María Ana
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1. Study Identification

Unique Protocol Identification Number
NCT04815486
Brief Title
Transcranial Magnetic Stimulation and Mental Representation Techniques for the Treatment of Stroke Patients
Official Title
Clinical Effects of Immersive Multimodal BCI-VR Training After Bilateral Stimulation With rTMS on Upper Limb Motor Recovery After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
May 18, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Francisco de Vitoria
Collaborators
Hospital Beata María Ana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
An immersive multimodal BCI-VR training and bilateral rTMS protocols are likely to complement their effects achieving a stronger neuroplasticity enhancement in stroke patients. Both have been used separately for the treatment of motor sequelae in the upper limbs after stroke. The main objective of this study is to carry out a double-blind, randomized, controlled trial aiming to study the clinical effect of Neurow system (NeuroRehabLab, Lisbon, Portugal) over bilateral rTMS plus conventional rehabilitation in upper limb motor sequelae after subacute stroke (3 to 12 months). We will look for changes in 1. Isometric strength in upper limb, 2. Functional motor scales of upper limb, 3. Hand dexterity 4. Cortical excitability changes. The investigators in the present project hypothesize that both neuromodulation techniques combined will be superior to the use of rTMS alone as adjuvant therapy to conventional rehabilitation.
Detailed Description
Stroke is a leading cause of long-term disability, it reduces mobility in more than half of stroke survivors age 65 and over. Despite the lack of objective prognostic factors regarding the patient´s functionality after a stroke, we know that age, the level of initial disability, and the location and size of the lesion are elements that affect the evolution of post-stroke rehabilitation. After stroke, the recovery of lost functions in the brain is achieved thanks to reorganizing networks in a process known as plasticity. Some damaged brain tissue may recover, or undamaged areas take over some functions. One of the most relevant aspects of the rehabilitation prognosis is the time of evolution. After stroke, improvement is noticeably reduced over the second month, finding stabilization around the sixth month. One of the reasons for this is the reduction of neuroplasticity. There are indicative studies that reflect that, six months after a stroke, more than 60% of subjects will have a non-functional hand for Basic Activities of Daily Living (BADL), and 20-25% will not be able to walk without assistance. This determines the important global burden that stroke represents. It is relevant to emphasize the degree of disability after the rehabilitation process will be determined by the combination of existing motor, sensory and neuropsychological deficiencies. In the last years, several non-invasive neuromodulation techniques have been shown efficient to enhance plasticity and stroke recovery. Among these interventions we can find exogenous neuromodulation, meaning that the neuromodulator stimulus comes from an external source, as is the case with rTMS (repetitive transcranial magnetic stimulation) which has the capacity to change the cortical excitability depending on the frequency of the magnetic pulses. Low frequencies (≤ 1 Hz) reduce local neural activity and high frequencies (≥ 5 Hz) increase cortical excitability. This technique has been successfully used bilaterally, stimulating the injured hemisphere and inhibiting the healthy one, to treat the interhemispheric inhibition phenomenon in stroke patients as it influences stroke recovery. On the other hand, there are endogenous neuromodulation techniques that depend on the capacity of the subject to modulate its own brain activity. This can be achieved using neurofeedback (NFB), this consists of recording information of brain activity using electroencephalography (EEG) or functional magnetic resonance (fMRI) and displaying it to the subject in such way that he can receive a real time information of his own brain function. Virtual reality allows a new dimension on the neurofeedback immersion, and is likely to increase its efficacy. Stroke patients have been trained to reinforce certain EEG rhythms related with motor performance using NFB technique showing favourable effects on rehabilitation outcomes. Some other techniques aiming to increase brain plasticity use the practice of imagination of movement of the affected hemibody. This is known as motor imagery and can be also enhanced through the use of brain computer interfaces. All the neuromodulation techniques are used to complement but not as a replacement of conventional rehabilitation. On one hand exogenous neuromodulation effects are produced mainly by changes directly induced in cortical excitability and on the other hand endogenous neuromodulation is believed to have more widespread subcortical effects. One of the probable causes of the short-term effects of these techniques is the ceiling effect of changes in cortical excitability that can be achieved non-invasively, but despite of the good results achieved with the use of non-invasive neuromodulation techniques individually, there is a shortage of validated neurorehabilitation protocols that integrate different approaches that have been proven to be effective individually. Neurow system (NeuroRehabLab, Lisbon, Portugal) is an immersive multimodal BCI-VR training system that combines motor imagery and neurofeedback through BCIs, using virtual reality has been designed to be used in chronic stroke patients, its efficacy has been shown in a pilot study. Both approaches, the Neurow system (NeuroRehabLab, Lisbon, Portugal) and bilateral rTMS protocols are likely to complement their effects achieving a stronger neuroplasticity enhancement in stroke patients. Both have been used separately for the treatment of motor sequelae in the upper limbs after stroke. The effects of these combined techniques are not likely to be based only in the increase of cortical excitability but also on subcortical mechanisms. The main objective of this study is to carry out a double-blind, randomized, controlled trial aiming to study the clinical effect of Neurow system (NeuroRehabLab, Lisbon, Portugal) over bilateral rTMS plus conventional rehabilitation in upper limb motor sequelae after subacute stroke (3 to 12 months). We will look for changes in 1. Isometric strength in upper limb, 2. Functional motor scales of upper limb, 3. Hand dexterity 4. Cortical excitability changes. Our main hypothesis is that both neuromodulation techniques combined will be superior to the use of rTMS alone as adjuvant therapy to conventional rehabilitation. This protocol combines techniques that have proven to be cost-effective. If it is shown that the clinical improvement with this combination is significant, it will be open a new line of combined neuromodulation approaches to reach and effective method for the upper limb motor neurorehabilitation of after a stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, rTMS, Motor Imagery, BCI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The clinical trial will follow an AB/BA crossover design with a counterbalanced assignment, in which the first 50% of the sample will be assigned to order AB and the second 50% to order BA. The washout period between therapies A and B will be always a month.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bilateral rTMS combined with MI through a BCI training platform in VR with NeuRow
Arm Type
Experimental
Arm Description
Sequential active rTMS at low frequency (healthy hemisphere) and high-frequency (injured hemisphere) application during 10 sessions in two weeks, and Motor Imagery (MI) treatment through the BCI training paradigm in VR (NeuRow) for 12 sessions in four weeks (3 sessions a week).The first 6 MI-neurofeedback sessions will carry out after bilateral stimulation with rTMS (i.e., rTMS as a priming method during the first two weeks), and the last 6 sessions, without rTMS as prior priming during the last two weeks
Arm Title
Repetitive TMS in bilateral cortical primary motor area
Arm Type
Active Comparator
Arm Description
Sequential active rTMS at low frequency (healthy hemisphere) and high-frequency (injured hemisphere) application during 10 sessions in two weeks.
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation (rTMS)
Other Intervention Name(s)
Therapy A
Intervention Description
Active rTMS in 10 daily sessions in two weeks of sequential application of: 90% RMT at 1Hz, 1000 pulses/day, 25s inter train on M1 of lesioned hemisphere and 90% RMT at 10Hz, 1000 pulses/day, 50s inter train on M1 of healthy hemisphere.
Intervention Type
Device
Intervention Name(s)
Motor Imagery (MI) through a Brain-Computer Interface (BCI) training platform in Virtual Reality (VR) with NeuRow
Other Intervention Name(s)
Therapy B
Intervention Description
It will consist of a combination of the bilateral rTMS protocol and the MI-neurofeedback training. During this therapy, the patient received 10 consecutive daily sessions of bilateral rTMS (Monday to Friday, two weeks), with the same stimulation parameters as another therapy, and 12 non-consecutive sessions of MI-neurofeedback (three times a week for four weeks). The first 6 MI-neurofeedback sessions were carried out after bilateral stimulation with rTMS (i.e., rTMS as a priming method during the first two weeks), and the last 6 sessions, without rTMS as prior priming during the last two weeks.
Primary Outcome Measure Information:
Title
Change in Dynamometry
Description
A handheld analogic dynamometer (Jamar® Plus+ Hand Dynamometer, 0-90 kg) will be used to assess isometric grip strength. Patients will be positioned in a straight back chair with both feet on the floor and the forearm resting on a stable surface. Each patient will be instructed to assume a position of adducted and neutrally rotated shoulder. For the arm to be tested, the elbow was flexed to 90º, the forearm and wrist will be in neutral positions, and the fingers will be flexed as needed for a maximal contraction. Patients will perform a maximal isometric grip contraction until they reach maximal force output. Three measures will be taken with 1-minute rest between test, and the mean value will be recorded
Time Frame
Baseline
Title
Change in Dynamometry
Description
A handheld analogic dynamometer (Jamar® Plus+ Hand Dynamometer, 0-90 kg) will be used to assess isometric grip strength. Patients will be positioned in a straight back chair with both feet on the floor and the forearm resting on a stable surface. Each patient will be instructed to assume a position of adducted and neutrally rotated shoulder. For the arm to be tested, the elbow was flexed to 90º, the forearm and wrist will be in neutral positions, and the fingers will be flexed as needed for a maximal contraction. Patients will perform a maximal isometric grip contraction until they reach maximal force output. Three measures will be taken with 1-minute rest between test, and the mean value will be recorded
Time Frame
From Baseline at 2 weeks
Title
Change in Dynamometry
Description
A handheld analogic dynamometer (Jamar® Plus+ Hand Dynamometer, 0-90 kg) will be used to assess isometric grip strength. Patients will be positioned in a straight back chair with both feet on the floor and the forearm resting on a stable surface. Each patient will be instructed to assume a position of adducted and neutrally rotated shoulder. For the arm to be tested, the elbow was flexed to 90º, the forearm and wrist will be in neutral positions, and the fingers will be flexed as needed for a maximal contraction. Patients will perform a maximal isometric grip contraction until they reach maximal force output. Three measures will be taken with 1-minute rest between test, and the mean value will be recorded
Time Frame
From Baseline at 4 weeks
Title
Change in Dynamometry
Description
A handheld analogic dynamometer (Jamar® Plus+ Hand Dynamometer, 0-90 kg) will be used to assess isometric grip strength. Patients will be positioned in a straight back chair with both feet on the floor and the forearm resting on a stable surface. Each patient will be instructed to assume a position of adducted and neutrally rotated shoulder. For the arm to be tested, the elbow was flexed to 90º, the forearm and wrist will be in neutral positions, and the fingers will be flexed as needed for a maximal contraction. Patients will perform a maximal isometric grip contraction until they reach maximal force output. Three measures will be taken with 1-minute rest between test, and the mean value will be recorded
Time Frame
From Baseline at 6 weeks
Title
Change in Fugl-Meyer Assessment for upper extremity score
Description
It is an observational rating scale that assesses sensorimotor impairments in post-stroke patients. It also includes four subscales: A. Upper Extremity (0-36), B. Wrist (0-10), C. Hand (0-14), D. Coordination/Speed (0-6) composing a total maximum score of 66 points. The therapist will rate each item according to direct observation of the motor performance, using a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, and 2 = performs fully) with lower scores indicating more impairments. The FMA is easy to use and has excellent validity, reliability, and responsiveness.
Time Frame
Baseline
Title
Change in Fugl-Meyer Assessment for upper extremity score
Description
It is an observational rating scale that assesses sensorimotor impairments in post-stroke patients. It also includes four subscales: A. Upper Extremity (0-36), B. Wrist (0-10), C. Hand (0-14), D. Coordination/Speed (0-6) composing a total maximum score of 66 points. The therapist will rate each item according to direct observation of the motor performance, using a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, and 2 = performs fully) with lower scores indicating more impairments. The FMA is easy to use and has excellent validity, reliability, and responsiveness.
Time Frame
From Baseline at 2 weeks
Title
Change in Fugl-Meyer Assessment for upper extremity score
Description
It is an observational rating scale that assesses sensorimotor impairments in post-stroke patients. It also includes four subscales: A. Upper Extremity (0-36), B. Wrist (0-10), C. Hand (0-14), D. Coordination/Speed (0-6) composing a total maximum score of 66 points. The therapist will rate each item according to direct observation of the motor performance, using a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, and 2 = performs fully) with lower scores indicating more impairments. The FMA is easy to use and has excellent validity, reliability, and responsiveness.
Time Frame
From Baseline at 4 weeks
Title
Change in Fugl-Meyer Assessment for upper extremity score
Description
It is an observational rating scale that assesses sensorimotor impairments in post-stroke patients. It also includes four subscales: A. Upper Extremity (0-36), B. Wrist (0-10), C. Hand (0-14), D. Coordination/Speed (0-6) composing a total maximum score of 66 points. The therapist will rate each item according to direct observation of the motor performance, using a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, and 2 = performs fully) with lower scores indicating more impairments. The FMA is easy to use and has excellent validity, reliability, and responsiveness.
Time Frame
From Baseline at 6 weeks
Title
Change in Stroke Impact Scale score
Description
It is a stroke-specific quality of life instrument to assess the consequences of stroke and to determine the quality of life improvement after stroke rehabilitation. It presents 4 subscales, but only hand function domain will be evaluated. Lower scores indicate more impairment in quality of life. The Minimal Detectable Change (MDC) and Clinically Important Difference (CID) of the hand function subscale are 25.9 and 17.8 points, respectively.
Time Frame
Baseline
Title
Change in Stroke Impact Scale score
Description
It is a stroke-specific quality of life instrument to assess the consequences of stroke and to determine the quality of life improvement after stroke rehabilitation. It presents 4 subscales, but only hand function domain will be evaluated. Lower scores indicate more impairment in quality of life. The Minimal Detectable Change (MDC) and Clinically Important Difference (CID) of the hand function subscale are 25.9 and 17.8 points, respectively.
Time Frame
From Baseline at 2 weeks
Title
Change in Stroke Impact Scale score
Description
It is a stroke-specific quality of life instrument to assess the consequences of stroke and to determine the quality of life improvement after stroke rehabilitation. It presents 4 subscales, but only hand function domain will be evaluated. Lower scores indicate more impairment in quality of life. The Minimal Detectable Change (MDC) and Clinically Important Difference (CID) of the hand function subscale are 25.9 and 17.8 points, respectively.
Time Frame
From Baseline at 4 weeks
Title
Change in Stroke Impact Scale score
Description
It is a stroke-specific quality of life instrument to assess the consequences of stroke and to determine the quality of life improvement after stroke rehabilitation. It presents 4 subscales, but only hand function domain will be evaluated. Lower scores indicate more impairment in quality of life. The Minimal Detectable Change (MDC) and Clinically Important Difference (CID) of the hand function subscale are 25.9 and 17.8 points, respectively.
Time Frame
From Baseline at 6 weeks
Title
Change in Motricity Index of the Arm
Description
The upper limb section of the MI assesses muscle strength in 3 muscle groups, including grip, elbow flexion, and shoulder separation. Each movement is scored discreetly (0 if there is no movement, 9 if the movement is palpable, 14 if the movement is visible, 19 if the movement is against gravity, 25 if the movement is against resistance and 33 if the movement is normal ), obtaining a total score for the upper limb that ranges from 0 (severely affected) to 100 (normal). This assessment methodology has been widely used in rehabilitation progress evaluation and counts with a normalized and weighted scoring system.
Time Frame
Baseline
Title
Change in Motricity Index of the Arm
Description
The upper limb section of the MI assesses muscle strength in 3 muscle groups, including grip, elbow flexion, and shoulder separation. Each movement is scored discreetly (0 if there is no movement, 9 if the movement is palpable, 14 if the movement is visible, 19 if the movement is against gravity, 25 if the movement is against resistance and 33 if the movement is normal ), obtaining a total score for the upper limb that ranges from 0 (severely affected) to 100 (normal). This assessment methodology has been widely used in rehabilitation progress evaluation and counts with a normalized and weighted scoring system.
Time Frame
From Baseline at 2 weeks
Title
Change in Motricity Index of the Arm
Description
The upper limb section of the MI assesses muscle strength in 3 muscle groups, including grip, elbow flexion, and shoulder separation. Each movement is scored discreetly (0 if there is no movement, 9 if the movement is palpable, 14 if the movement is visible, 19 if the movement is against gravity, 25 if the movement is against resistance and 33 if the movement is normal ), obtaining a total score for the upper limb that ranges from 0 (severely affected) to 100 (normal). This assessment methodology has been widely used in rehabilitation progress evaluation and counts with a normalized and weighted scoring system.
Time Frame
From Baseline at 4 weeks
Title
Change in Motricity Index of the Arm
Description
The upper limb section of the MI assesses muscle strength in 3 muscle groups, including grip, elbow flexion, and shoulder separation. Each movement is scored discreetly (0 if there is no movement, 9 if the movement is palpable, 14 if the movement is visible, 19 if the movement is against gravity, 25 if the movement is against resistance and 33 if the movement is normal ), obtaining a total score for the upper limb that ranges from 0 (severely affected) to 100 (normal). This assessment methodology has been widely used in rehabilitation progress evaluation and counts with a normalized and weighted scoring system.
Time Frame
From Baseline at 6 weeks
Secondary Outcome Measure Information:
Title
Change in Electroencephalogram data
Description
Mu (μ) is a type of rhythm in which α frequency can be found in sensorimotor cortex. Its changes are related with movement. M1 Mu (μ) rhythms will be assessed to evaluate changes in cortical function. They have been shown to be very useful in evaluating stroke patients recovery.
Time Frame
Baseline
Title
Change in Electroencephalogram data
Description
Mu (μ) is a type of rhythm in which α frequency can be found in sensorimotor cortex. Its changes are related with movement. M1 Mu (μ) rhythms will be assessed to evaluate changes in cortical function. They have been shown to be very useful in evaluating stroke patients recovery.
Time Frame
At 2 weeks from Baseline
Title
Change in Electroencephalogram data
Description
Mu (μ) is a type of rhythm in which α frequency can be found in sensorimotor cortex. Its changes are related with movement. M1 Mu (μ) rhythms will be assessed to evaluate changes in cortical function. They have been shown to be very useful in evaluating stroke patients recovery.
Time Frame
At 4 weeks from Baseline
Title
Change in Electroencephalogram data
Description
Mu (μ) is a type of rhythm in which α frequency can be found in sensorimotor cortex. Its changes are related with movement. M1 Mu (μ) rhythms will be assessed to evaluate changes in cortical function. They have been shown to be very useful in evaluating stroke patients recovery.
Time Frame
At 6 weeks from Baseline
Title
Change in Nottingham Sensory Assessment (NSA)
Description
Nottingham Sensory Assessment (NSA): Somatosensory impairment of the upper limb occurs in approximately 50% of adults after stroke, associated with loss of hand motor function, activity, and participation. The measurement of sensory impairment in the upper limb is a component of rehabilitation that contributes to the selection of sensorimotor techniques that optimize recovery and provide a prognostic estimate of the function of the affected upper limb.There are studies documenting changes produced in the sensation of the upper limb after the application of neurofeedback, and even after the intervention with motor imagery. Since the protocol presents an intervention with the application of these techniques, it is possible that there will be changes related to the sensitivity after the use of the platform, Neurow system (NeuroRehabLab, Lisbon, Portugal).
Time Frame
Baseline
Title
Change in Nottingham Sensory Assessment (NSA)
Description
Nottingham Sensory Assessment (NSA): Somatosensory impairment of the upper limb occurs in approximately 50% of adults after stroke, associated with loss of hand motor function, activity, and participation. The measurement of sensory impairment in the upper limb is a component of rehabilitation that contributes to the selection of sensorimotor techniques that optimize recovery and provide a prognostic estimate of the function of the affected upper limb.There are studies documenting changes produced in the sensation of the upper limb after the application of neurofeedback, and even after the intervention with motor imagery. Since the protocol presents an intervention with the application of these techniques, it is possible that there will be changes related to the sensitivity after the use of the platform, Neurow system (NeuroRehabLab, Lisbon, Portugal).
Time Frame
From Baseline at 4 weeks
Title
Change in Nottingham Sensory Assessment (NSA)
Description
Nottingham Sensory Assessment (NSA): Somatosensory impairment of the upper limb occurs in approximately 50% of adults after stroke, associated with loss of hand motor function, activity, and participation. The measurement of sensory impairment in the upper limb is a component of rehabilitation that contributes to the selection of sensorimotor techniques that optimize recovery and provide a prognostic estimate of the function of the affected upper limb.There are studies documenting changes produced in the sensation of the upper limb after the application of neurofeedback, and even after the intervention with motor imagery. Since the protocol presents an intervention with the application of these techniques, it is possible that there will be changes related to the sensitivity after the use of the platform, Neurow system (NeuroRehabLab, Lisbon, Portugal).
Time Frame
From Baseline at 6 weeks
Title
Change in Finger Tapping Task
Description
It measures motor function and is very sensitive to the slowing down of responses. In this task, following the Strauss application norms, the participants will be instructed to press the space-bar on the keyboard as fast as possible and repeatedly with the index finger. Five 10-second attempts will be performed with the dominant hand. The average time between two consecutive taps in the five trials will be the dependent variable.
Time Frame
Baseline
Title
Change in Finger Tapping Task
Description
It measures motor function and is very sensitive to the slowing down of responses. In this task, following the Strauss application norms, the participants will be instructed to press the space-bar on the keyboard as fast as possible and repeatedly with the index finger. Five 10-second attempts will be performed with the dominant hand. The average time between two consecutive taps in the five trials will be the dependent variable.
Time Frame
From Baseline at 4 weeks
Title
Change in Finger Tapping Task
Description
It measures motor function and is very sensitive to the slowing down of responses. In this task, following the Strauss application norms, the participants will be instructed to press the space-bar on the keyboard as fast as possible and repeatedly with the index finger. Five 10-second attempts will be performed with the dominant hand. The average time between two consecutive taps in the five trials will be the dependent variable.
Time Frame
From Baseline at 6 weeks
Title
Change in Nine Hole Peg Test
Description
It evaluates the impairment in upper limb dexterity. Patients must pick up as quick as possible, nine pegs from a container one-by-one unimanually and transfer them into a target pegboard with nine holes until filled. Then, they must return them unimanually to the container. The outcome variable will be the time spent to complete the whole task. This test is considered reliable, valid, and sensitive to change, among stroke patients.
Time Frame
Baseline
Title
Change in Nine Hole Peg Test
Description
It evaluates the impairment in upper limb dexterity. Patients must pick up as quick as possible, nine pegs from a container one-by-one unimanually and transfer them into a target pegboard with nine holes until filled. Then, they must return them unimanually to the container. The outcome variable will be the time spent to complete the whole task. This test is considered reliable, valid, and sensitive to change, among stroke patients.
Time Frame
From Baseline at 4 weeks
Title
Change in Nine Hole Peg Test
Description
It evaluates the impairment in upper limb dexterity. Patients must pick up as quick as possible, nine pegs from a container one-by-one unimanually and transfer them into a target pegboard with nine holes until filled. Then, they must return them unimanually to the container. The outcome variable will be the time spent to complete the whole task. This test is considered reliable, valid, and sensitive to change, among stroke patients.
Time Frame
From Baseline at 6 weeks
Title
Change in Modified Ashworth Scale score
Description
Patients will be in the supine position with their arms by their side and with their head in neutral position. Wrist and elbow muscles resistance will be assessed during two repetitions of a passive motion within one second and measured on the following scale: 0 = no increased resistance; 1 = slightly increase resistance (at the end of the range of motion); 1+ = slightly increase resistance (less than half of the range of motion); 2 = clear resistance (most of the range of motion); 3 = strong resistance; 4 = rigid flexion or extension. It is markedly responsive in detecting the changes in muscle tone in patients with stroke and its minimal clinically important difference of effect sizes 0.5 and 0.8 standard deviations for the upper extremity muscles are 0.48 and 0.76, respectively.
Time Frame
Baseline
Title
Change in Modified Ashworth Scale score
Description
Patients will be in the supine position with their arms by their side and with their head in neutral position. Wrist and elbow muscles resistance will be assessed during two repetitions of a passive motion within one second and measured on the following scale: 0 = no increased resistance; 1 = slightly increase resistance (at the end of the range of motion); 1+ = slightly increase resistance (less than half of the range of motion); 2 = clear resistance (most of the range of motion); 3 = strong resistance; 4 = rigid flexion or extension. It is markedly responsive in detecting the changes in muscle tone in patients with stroke and its minimal clinically important difference of effect sizes 0.5 and 0.8 standard deviations for the upper extremity muscles are 0.48 and 0.76, respectively.
Time Frame
Baseline at 4 weeks
Title
Change in Modified Ashworth Scale score
Description
Patients will be in the supine position with their arms by their side and with their head in neutral position. Wrist and elbow muscles resistance will be assessed during two repetitions of a passive motion within one second and measured on the following scale: 0 = no increased resistance; 1 = slightly increase resistance (at the end of the range of motion); 1+ = slightly increase resistance (less than half of the range of motion); 2 = clear resistance (most of the range of motion); 3 = strong resistance; 4 = rigid flexion or extension. It is markedly responsive in detecting the changes in muscle tone in patients with stroke and its minimal clinically important difference of effect sizes 0.5 and 0.8 standard deviations for the upper extremity muscles are 0.48 and 0.76, respectively.
Time Frame
Baseline at 6 weeks
Title
Change in TMS Resting Motor Threshold (RMT) and cortical silent period (CSP)
Description
In the first dorsal interosseous muscle or the abductor pollicis brevis muscle will be recorded to determine the cortical excitability changes and correlate them with the clinical outcomes.
Time Frame
Baseline
Title
Change in TMS Resting Motor Threshold (RMT)and cortical silent period (CSP)
Description
In the first dorsal interosseous muscle or the abductor pollicis brevis muscle will be recorded to determine the cortical excitability changes and correlate them with the clinical outcomes.
Time Frame
From Baseline at 2 weeks
Title
Change in TMS Resting Motor Threshold (RMT)and cortical silent period (CSP)
Description
In the first dorsal interosseous muscle or the abductor pollicis brevis muscle will be recorded to determine the cortical excitability changes and correlate them with the clinical outcomes.
Time Frame
From Baseline at 4 weeks
Title
Change in TMS Resting Motor Threshold (RMT) and cortical silent period (CSP)
Description
In the first dorsal interosseous muscle or the abductor pollicis brevis muscle will be recorded to determine the cortical excitability changes and correlate them with the clinical outcomes.
Time Frame
From Baseline at 6 weeks
Title
Change in Barthel Index(BI)
Description
Accurately assessing the ADLs of stroke patients greatly helps in evaluating the efficacy of stroke treatments. The Barthel Index was originally established to assess ADL in stroke patients and has been used extensively for this purpose.
Time Frame
Baseline
Title
Change in Barthel Index(BI)
Description
Accurately assessing the ADLs of stroke patients greatly helps in evaluating the efficacy of stroke treatments. The Barthel Index was originally established to assess ADL in stroke patients and has been used extensively for this purpose.
Time Frame
From Baseline at 4 weeks
Title
Change in Barthel Index(BI)
Description
Accurately assessing the ADLs of stroke patients greatly helps in evaluating the efficacy of stroke treatments. The Barthel Index was originally established to assess ADL in stroke patients and has been used extensively for this purpose.
Time Frame
From Baseline at 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Older than 18 years old. Ischemic or hemorrhagic cerebrovascular injury diagnosed by a neurologist and who have at least one brain-imaging test. The onset of hemispheric ischemic or hemorrhagic stroke> 3 months. Presence of upper limb motor sequelae due to stroke. Sufficient cognitive ability to understand and perform tasks: Token Test> 11. Stability in antispastic medication for more than 5 days. Able to read and write. Exclusion Criteria: History of seizure or brain Pacemakers, medication pumps, metal implants in the head (except dental implants) Clinical unstability Other pre-existing neurological diseases or previous cerebrovascular accidents with sequelae. Sensory aphasia Previous TMS after stroke Hemispatial neglect, Flaccid paralysis Brunnstrom's stage < 1 Visual problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Pablo Romero Muñoz, MD PhD
Organizational Affiliation
Universidad Francisco de Vitoria, Facultad de Ciencias Experimentales
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Beata Maria Ana
City
Madrid
ZIP/Postal Code
28007
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual anonymized participant data will be available to other researchers under request.
IPD Sharing Time Frame
Six months at the end of the study.
IPD Sharing Access Criteria
Individual anonymized participant data will be available to other researchers under request.
Citations:
PubMed Identifier
27503007
Citation
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31354460
Citation
Vourvopoulos A, Jorge C, Abreu R, Figueiredo P, Fernandes JC, Bermudez I Badia S. Efficacy and Brain Imaging Correlates of an Immersive Motor Imagery BCI-Driven VR System for Upper Limb Motor Rehabilitation: A Clinical Case Report. Front Hum Neurosci. 2019 Jul 11;13:244. doi: 10.3389/fnhum.2019.00244. eCollection 2019.
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22792492
Citation
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Citation
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Citation
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Transcranial Magnetic Stimulation and Mental Representation Techniques for the Treatment of Stroke Patients

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