Longitudinal Validation of Neurofeedback in Stroke Motor Rehabilitation Through Brain Imaging
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
BCI intervention
Conventional Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Brain Computer Interface, Virtual Reality, Stroke rehabilitation, Electroencephalography, Motor Imagery
Eligibility Criteria
Inclusion Criteria:
- First stroke episode
- More than six months after stroke
- Stroke hemiplegia/hemiparesis, (Fugl Meyer below or equal to 47)
- Capacity to understand and complete simple tasks
- Know how to read and write
- Motivation to participate
Exclusion Criteria:
- Hemi spatial neglect
- Depressive symptoms, moderate to severe
- Presence of other neurological or orthopaedic problems
- Severe eyesight problems
- Claustrophobia
- Presence of ferromagnetic materials
Sites / Locations
- Serviço de Saúde da Região Autónoma da MadeiraRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Motor Imagery
Conventional Therapy
Arm Description
A Brain-Computer Interaction (BCI) based intervention while receiving conventional therapy. Use of motor imagery training, allied with brain-computer interaction, as a solution to promote motor and cognitive gains in stroke survivors.
Extra Occupational Therapy sessions while receiving conventional therapy. Use of conventional therapy techniques and tools for motor rehabilitation, following the original therapeutic intervention plan of the participants.
Outcomes
Primary Outcome Measures
Change from the baseline in the functional magnetic resonance imaging (fMRI)
Analyze cortical activation, during motor imagery exercises, and cortical structure.
Change from the baseline in the Fugl Meyer Motor Assessment
Evaluates the motor function of the affected upper limb. This section has a maximum score of 66 and changes to a higher score means an evolution on motor recovery.
Secondary Outcome Measures
Change from the baseline in the electroencephalography (EEG) data
Analyze brain activity during motor imagery training to identify the best EEG features that better correlate with the brain activity in motor areas of each participant using Common Spatial Pattern filters. Examine different modulation rhythms focusing on Alpha and Beta rhythms, during Motor imagery for each BCI session, aiming to find changes in brain activity, in motor and cognitive areas that are related to motor imagery. Some feature candidates are, Power, Connectivity and Event-Related Synchronization/Desynchronization (ERS/ERD) maps.
Change from the baseline in the Kinesthetic and Visual Imagery Questionnaire (KVIQ)
Assess the motor imagery capacity of the stroke participants. The maximum score is 100 and a high score reflects a greater ability to visualize and feel imaginary movements.
Change from the baseline in the Montreal Cognitive Assessment (MoCA)
The screening test used to assess different cognitive domains. The test has a total of 30 points; the higher the score the lesser the probability of cognitive impairment.
Change from the baseline in the Modified Ashworth Scale (MAS)
Assess muscle tone during movement, in the elbow joint. The score is valued from 0 to 4 (0, 1, 1+, 2, 3 and 4), a higher score is related to higher spasticity and muscle tone.
Change from the baseline in the Geriatric Depression Scale (GDS)
Self-report assessment to measure depression symptoms in the elderly. It has a maximum score of 30 points where a score superior to 21 is indicative of the presence of severe depression. From 11 to 20 points is indicative of mild depression and a score equal or inferior to 10, to the absence of depression.
Full Information
NCT ID
NCT04376138
First Posted
April 16, 2020
Last Updated
November 14, 2022
Sponsor
Universidade da Madeira
Collaborators
Serviço de Saúde da Região Autónoma da Madeira (SESARAM), E.P.E.
1. Study Identification
Unique Protocol Identification Number
NCT04376138
Brief Title
Longitudinal Validation of Neurofeedback in Stroke Motor Rehabilitation Through Brain Imaging
Official Title
Longitudinal Validation of Neurofeedback in Stroke Motor Rehabilitation Through Brain Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2019 (Actual)
Primary Completion Date
September 20, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade da Madeira
Collaborators
Serviço de Saúde da Região Autónoma da Madeira (SESARAM), E.P.E.
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
With the main goal of generalising findings into Virtual Reality-Neurofeedback-Motor imagery (VR-NF-MI) system, this project aims to develop a new motor rehabilitation tool, for the upper limb, allied to the use of rising of information and communication technologies (ICT). By identifying correlations on the neural activity, during motor imagery and through brain imaging (fMRI), with distinct training protocols and feedback, these protocols are developed to create user-specific models that later can be used in NF-MI rehabilitation sessions.
Detailed Description
Every year millions of people worldwide suffer from stroke, being one of the leading causes of death and longterm disability. This leads to cognitive and motor impairments, resulting in loss of independence in their daily life together with an additional psychological impact in mood disorders and depression. Evolving to a chronic condition, stroke requires continuous rehabilitation and therapy. Personalised Virtual-Reality (VR) approaches have been shown to accelerate the recovery process compared to non-Information and communication technologies (ICT) based interventions. However, most of these novel VR approaches are suitable only for a reduced subset of patients, generally those with better recovery prognostics and better motor control. Thus, the idea of training the central nervous system was established, through EEG-based neurofeedback (NF) and motor-imagery (MI). Although the benefits of MI-NF have been illustrated in a plethora of studies, the reduced ability for stroke patients to use NF does not allow an accurate control, reducing the capabilities of MI-NF systems. The aim of this project is to develop a novel and more inclusive rehabilitation system with the use of novel ICT technologies, in order to overcome current limitations. This will be achieved by identifying the neural correlates of motor action during motor imagery through brain imaging (fMRI), and differences in brain activation with different training feedback protocols for formulating user-specific models that will be used later in NF-MI rehabilitation sessions. This will facilitate the use of neural interfaces to train the central nervous system; specifically, the investigators will develop a personalized EEG-based immersive NF through VR for MI training. The ultimate goal is to generalize the findings into a VR-NF-MI training paradigm for both admitted and ambulatory patients as well as continued domestic care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Brain Computer Interface, Virtual Reality, Stroke rehabilitation, Electroencephalography, Motor Imagery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Motor Imagery
Arm Type
Experimental
Arm Description
A Brain-Computer Interaction (BCI) based intervention while receiving conventional therapy. Use of motor imagery training, allied with brain-computer interaction, as a solution to promote motor and cognitive gains in stroke survivors.
Arm Title
Conventional Therapy
Arm Type
Active Comparator
Arm Description
Extra Occupational Therapy sessions while receiving conventional therapy. Use of conventional therapy techniques and tools for motor rehabilitation, following the original therapeutic intervention plan of the participants.
Intervention Type
Other
Intervention Name(s)
BCI intervention
Other Intervention Name(s)
Brain Computer Interaction (BCI) and neurofeedback for stroke rehabilitation
Intervention Description
30 minutes intervention that occurs 3 times per week, with a goal of 12 sessions total.
Intervention Type
Other
Intervention Name(s)
Conventional Therapy
Other Intervention Name(s)
Traditional motor rehabilitation for the upper limb
Intervention Description
30 minutes intervention that occurs 3 times per week, with a goal of 12 sessions total.
Primary Outcome Measure Information:
Title
Change from the baseline in the functional magnetic resonance imaging (fMRI)
Description
Analyze cortical activation, during motor imagery exercises, and cortical structure.
Time Frame
Baseline, Final (4 weeks) and 1 month follow up
Title
Change from the baseline in the Fugl Meyer Motor Assessment
Description
Evaluates the motor function of the affected upper limb. This section has a maximum score of 66 and changes to a higher score means an evolution on motor recovery.
Time Frame
Baseline, Final (4 weeks) and 1 month follow up
Secondary Outcome Measure Information:
Title
Change from the baseline in the electroencephalography (EEG) data
Description
Analyze brain activity during motor imagery training to identify the best EEG features that better correlate with the brain activity in motor areas of each participant using Common Spatial Pattern filters. Examine different modulation rhythms focusing on Alpha and Beta rhythms, during Motor imagery for each BCI session, aiming to find changes in brain activity, in motor and cognitive areas that are related to motor imagery. Some feature candidates are, Power, Connectivity and Event-Related Synchronization/Desynchronization (ERS/ERD) maps.
Time Frame
In all 12 sessions for 4 weeks
Title
Change from the baseline in the Kinesthetic and Visual Imagery Questionnaire (KVIQ)
Description
Assess the motor imagery capacity of the stroke participants. The maximum score is 100 and a high score reflects a greater ability to visualize and feel imaginary movements.
Time Frame
Baseline, Final (4 weeks) and 1 month follow up
Title
Change from the baseline in the Montreal Cognitive Assessment (MoCA)
Description
The screening test used to assess different cognitive domains. The test has a total of 30 points; the higher the score the lesser the probability of cognitive impairment.
Time Frame
Baseline, Final (4 weeks) and 1 month follow up
Title
Change from the baseline in the Modified Ashworth Scale (MAS)
Description
Assess muscle tone during movement, in the elbow joint. The score is valued from 0 to 4 (0, 1, 1+, 2, 3 and 4), a higher score is related to higher spasticity and muscle tone.
Time Frame
Baseline, Final (4 weeks) and 1 month follow up
Title
Change from the baseline in the Geriatric Depression Scale (GDS)
Description
Self-report assessment to measure depression symptoms in the elderly. It has a maximum score of 30 points where a score superior to 21 is indicative of the presence of severe depression. From 11 to 20 points is indicative of mild depression and a score equal or inferior to 10, to the absence of depression.
Time Frame
Baseline, Final (4 weeks) and 1 month follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
First stroke episode
More than six months after stroke
Stroke hemiplegia/hemiparesis, (Fugl Meyer below or equal to 47)
Capacity to understand and complete simple tasks
Know how to read and write
Motivation to participate
Exclusion Criteria:
Hemi spatial neglect
Depressive symptoms, moderate to severe
Presence of other neurological or orthopaedic problems
Severe eyesight problems
Claustrophobia
Presence of ferromagnetic materials
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diego Mora, PhD
Phone
+351 926012984
Email
diego.mora@m-iti.org
First Name & Middle Initial & Last Name or Official Title & Degree
Carolina Jorge, BSc
Phone
+351 964974916
Email
carolia.jorge@m-iti.org
Facility Information:
Facility Name
Serviço de Saúde da Região Autónoma da Madeira
City
Funchal
State/Province
Madeira
ZIP/Postal Code
9004-514
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolina Jorge, Bachelor
Phone
+351 964974916
Email
carolina.jorge@m-iti.org
12. IPD Sharing Statement
Learn more about this trial
Longitudinal Validation of Neurofeedback in Stroke Motor Rehabilitation Through Brain Imaging
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