Back to resultsRepetitive Transcranial Magnetic Stimulation Associated With Physical Therapy to Reduce Upper Limb Spasticity in Post Stroke Patients
Primary Purpose
Chronic Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
TMS
Physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Stroke focused on measuring Repetitive transcranial magnetic stimulation, Physiotherapy, Stroke, Spasticity
Eligibility Criteria
Inclusion Criteria:
- Age 30 to 75 years;
- Both sexes;
- With diagnosis of ischemic or hemorrhagic stroke proven by means of computed tomography or magnetic resonance imaging;
- Spasticity grade will be assessed using the Ashworth modified scale (BOHANNON & SMITH, 1987), with score +1, 2 or 3 for the wrist flexors of the affected upper limb;
- With absence of cognitive deficit verified by the Folstein Mini Mental State Examination (score ≥ 20) modified for the Brazilian population (BRUCKI et al., 2003)
Exclusion Criteria:
- Contraindications to and EMT (ROSSINI et al., 2015)
- Clinical evidence of multiple brain lesions
- Trauma-orthopedic injury that limits the range of motion of the upper limb
- Presence of visual and / or communication deficit
- Involvement of other interventions focused on reducing spasticity
- Modification of medications in the last 30 days.
Sites / Locations
- Applied Neuroscience LaboratoryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Experimental: hf rTMS and Physical therapy
Control: Sham hf rTMS and Physical theraphy
Arm Description
High frequency TMS will be applied with an eight shaped coil angled at 45 degrees from the sagittal axis and positioned at the C3 or C4 in accordance with the international 10-20 marking system (JASPER, 1958), which corresponds to the right or left primary motor cortex (M1) injured. Forty stimulus trains will be provide at 10Hz over the injured hemisphere, at 10 Hz for five seconds each. The interval between the trains will be 25 seconds, totaling 2000 pulses for approximately 20 minutes, with 120% of resting motor threshold (RMT). After TMS, patients will be submitted to 50 minutes of physical therapy protocol.
In this group, the volunteer will start with sham TMS, will be the same parameters was used in experimental group, however, it will be performed using two coils, one connected to the magnetic stimulator, away from the patient's scalp and another uncoupled from the stimulator and positioned in the same way as in real stimulation. After, the volunteer will be submitted to 50 minutes of physical therapy protocol.
Outcomes
Primary Outcome Measures
Spasticity
Change from degree of Spasticity: ordinal variable measured through the Ashworth Modified Scale, expressed as scores graded from +1 to 3. The EMA is a qualitative instrument with ordinal measures that scores the degree of spasticity presented by the resting muscle from zero to four, in increasing order of intensity.
Secondary Outcome Measures
Cortical excitability
Expressed as percent motor resting threshold and numerical values of motor evoked potential. The motor evoked potential (MEP) will be provided by twenty unconditioned stimuli (120% of motor resting threshould).
Variation of the median nerve Hmax / Mmax ratio
The reflex H is an estimate of the excitability of the alpha motoneuron when there is a pre-synaptic inhibition (PALIERI, R.M et al., 2004). The variation of the H-reflex amplitude will evaluate the spinal cord excitability variation.
Sensory-motor function of the upper limb
This consists of a quantitative scale developed to measure the recovery of the motor function of stroke patients.Measured through the Fugl-Meyer Rating Scale. Expressed in values from 0 to 66;
Quality of life
Expressed in numerical values for each domain, the SSQOL has 49 items distributed in 12 domains (energy, family role, language, mobility, humor, personality, self-care, social role, reasoning, upper limb function, vision and work / productivity). There are three possibilities for responses that are quantified on a five-to-one scale.
Qualitative and quantitative of moviment
Motor Activity Log 30 (MAL-30) is a standardized instrument that was developed specifically to evaluate the function and use of the upper limb most affected post-stroke in the real-life environment (uncontrolled) through two scales: qualitative and quantitative. The total score is obtained by calculating the mean for each of the scales. The higher the mean obtained in the scales, the better the quality and quantity of use of the upper limb more affected in the accomplishment of the daily activities of life.
Dynamometry
It consists of an objective and quantitative way of measuring muscle shape using a manual portable dynamometer. The test will be performed with the Jamar dynamometer in KGF.
Changes on Patient Global Impression of Change Scale
Changes on Patient Global Impression of Change Scale - (time frame: baseline, before 6 session, after 10 sessions)
The PGICS is a one-dimensional measure in which individuals rate their improvement associated with intervention on a scale of 7 items ranging from "1 = no change" to "7 = Much better".
Full Information
NCT ID
NCT03481179
First Posted
February 1, 2018
Last Updated
March 21, 2018
Sponsor
Universidade Federal de Pernambuco
1. Study Identification
Unique Protocol Identification Number
NCT03481179
Brief Title
Repetitive Transcranial Magnetic Stimulation Associated With Physical Therapy to Reduce Upper Limb Spasticity in Post Stroke Patients
Official Title
Efficacy of High Frequency Repetitive Transcranial Magnetic Stimulation Associated With Physical Therapy to Reduce Upper Limb Spasticity in Post Stroke Patients: Double Blinded, Randomized and Controlled Clinical
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
April 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this study, it is being investigated if the association between high frequency repetitive transcranial magnetic stimulation associated with motor physical therapy reduces spasticity, increases upper limb motor function, and quality of life of post-chronic stroke patients than motor physical therapy alone. For this purpose, patients included will be submitted to ten sessions with active or sham hf-rTMS followed by a protocol of physical therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke
Keywords
Repetitive transcranial magnetic stimulation, Physiotherapy, Stroke, Spasticity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: hf rTMS and Physical therapy
Arm Type
Experimental
Arm Description
High frequency TMS will be applied with an eight shaped coil angled at 45 degrees from the sagittal axis and positioned at the C3 or C4 in accordance with the international 10-20 marking system (JASPER, 1958), which corresponds to the right or left primary motor cortex (M1) injured. Forty stimulus trains will be provide at 10Hz over the injured hemisphere, at 10 Hz for five seconds each. The interval between the trains will be 25 seconds, totaling 2000 pulses for approximately 20 minutes, with 120% of resting motor threshold (RMT). After TMS, patients will be submitted to 50 minutes of physical therapy protocol.
Arm Title
Control: Sham hf rTMS and Physical theraphy
Arm Type
Sham Comparator
Arm Description
In this group, the volunteer will start with sham TMS, will be the same parameters was used in experimental group, however, it will be performed using two coils, one connected to the magnetic stimulator, away from the patient's scalp and another uncoupled from the stimulator and positioned in the same way as in real stimulation. After, the volunteer will be submitted to 50 minutes of physical therapy protocol.
Intervention Type
Device
Intervention Name(s)
TMS
Other Intervention Name(s)
non invasive brain stimulation, high frequency rTMS
Intervention Description
Repetitive TMS involves application of electric currents in the patient's cortex by a magnetic field applied to the scalp of the patient through an eight-coil connected to a magnetic stimulator (MagStim Rapid² magnetic stimulator-UK). In a small percentage of patients, it may cause some discomfort with a mild headache sensation or nausea. Depending on the parameters, rTMS can increase or decrease corticomotor excitability and by the connection of the motor cortex with the thalamus, influencing spasticity inhibition. The patients will respond to an adverse effects questionnaire and will report the perception of real or sham stimulation.
Intervention Type
Other
Intervention Name(s)
Physical therapy
Intervention Description
The physical therapy, with an duration of 40-50 minutes, will be focused on the upper limbs and will be based on the principles of neuroplasticity (repetition, intensity, specificity, among others (KLEIM & JONES, 2008), with a protocol that will cover different exercises and degrees of difficulty, which will be chosen according to the need and capacity of each patient
Primary Outcome Measure Information:
Title
Spasticity
Description
Change from degree of Spasticity: ordinal variable measured through the Ashworth Modified Scale, expressed as scores graded from +1 to 3. The EMA is a qualitative instrument with ordinal measures that scores the degree of spasticity presented by the resting muscle from zero to four, in increasing order of intensity.
Time Frame
before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days
Secondary Outcome Measure Information:
Title
Cortical excitability
Description
Expressed as percent motor resting threshold and numerical values of motor evoked potential. The motor evoked potential (MEP) will be provided by twenty unconditioned stimuli (120% of motor resting threshould).
Time Frame
before and after 10 daily sessions and after 30 days
Title
Variation of the median nerve Hmax / Mmax ratio
Description
The reflex H is an estimate of the excitability of the alpha motoneuron when there is a pre-synaptic inhibition (PALIERI, R.M et al., 2004). The variation of the H-reflex amplitude will evaluate the spinal cord excitability variation.
Time Frame
before and after 10 sessions and after 30 days
Title
Sensory-motor function of the upper limb
Description
This consists of a quantitative scale developed to measure the recovery of the motor function of stroke patients.Measured through the Fugl-Meyer Rating Scale. Expressed in values from 0 to 66;
Time Frame
before and after 10 daily sessions and after 30 days
Title
Quality of life
Description
Expressed in numerical values for each domain, the SSQOL has 49 items distributed in 12 domains (energy, family role, language, mobility, humor, personality, self-care, social role, reasoning, upper limb function, vision and work / productivity). There are three possibilities for responses that are quantified on a five-to-one scale.
Time Frame
before and after 10 daily sessions and after 30 days
Title
Qualitative and quantitative of moviment
Description
Motor Activity Log 30 (MAL-30) is a standardized instrument that was developed specifically to evaluate the function and use of the upper limb most affected post-stroke in the real-life environment (uncontrolled) through two scales: qualitative and quantitative. The total score is obtained by calculating the mean for each of the scales. The higher the mean obtained in the scales, the better the quality and quantity of use of the upper limb more affected in the accomplishment of the daily activities of life.
Time Frame
before and after 10 daily sessions and after 30 days
Title
Dynamometry
Description
It consists of an objective and quantitative way of measuring muscle shape using a manual portable dynamometer. The test will be performed with the Jamar dynamometer in KGF.
Time Frame
before and after 10 daily sessions and after 30 days
Title
Changes on Patient Global Impression of Change Scale
Description
Changes on Patient Global Impression of Change Scale - (time frame: baseline, before 6 session, after 10 sessions)
The PGICS is a one-dimensional measure in which individuals rate their improvement associated with intervention on a scale of 7 items ranging from "1 = no change" to "7 = Much better".
Time Frame
before and after 10 daily sessions and after 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 30 to 75 years;
Both sexes;
With diagnosis of ischemic or hemorrhagic stroke proven by means of computed tomography or magnetic resonance imaging;
Spasticity grade will be assessed using the Ashworth modified scale (BOHANNON & SMITH, 1987), with score +1, 2 or 3 for the wrist flexors of the affected upper limb;
With absence of cognitive deficit verified by the Folstein Mini Mental State Examination (score ≥ 20) modified for the Brazilian population (BRUCKI et al., 2003)
Exclusion Criteria:
Contraindications to and EMT (ROSSINI et al., 2015)
Clinical evidence of multiple brain lesions
Trauma-orthopedic injury that limits the range of motion of the upper limb
Presence of visual and / or communication deficit
Involvement of other interventions focused on reducing spasticity
Modification of medications in the last 30 days.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kátia Monte-Silva, PhD
Phone
+55 81 988631322
Email
monte.silvakk@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Camilla Sales, PT
Phone
+55 81 997299255
Email
millbasales@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kátia Monte-Silva, PhD
Organizational Affiliation
Applied Neuroscience Laboratory, Universidade Federal de Pernambuco
Official's Role
Study Director
Facility Information:
Facility Name
Applied Neuroscience Laboratory
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50740-560
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camilla Sales, PT
Email
millabsales@gmail.com
First Name & Middle Initial & Last Name & Degree
Rebeca Dias, PT
First Name & Middle Initial & Last Name & Degree
Kátia K Monte-Silva, PhD
12. IPD Sharing Statement
Learn more about this trial
Repetitive Transcranial Magnetic Stimulation Associated With Physical Therapy to Reduce Upper Limb Spasticity in Post Stroke Patients
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