BCI Post-stroke Neurorehabilitation

Study Overview
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Brief Summary
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The goal is to evaluate the potential of a EEG based BCI (Brain-Computer-Interface) connected to a non-invasive pneumatic glove for rehabilitation of hand-movements post-stroke.

Detailed Description
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Brain computer interfaces (BCI) encompasses the usage of the brain signals to compensate for lost physical function. The current protocol evaluates the therapeutic potential of a EEG based driven BCI that is connected to a non-invasive pneumatic glove for rehabilitation of hand flexion/extension post-stroke. The system non-invasive, portable and low-cost. The utility and usability of the system will be investigated at two levels. First by means of questionnaires for patients and therapist and second by means of in depth analysis of the EEG signals during intended, imagined and passive driven hand movements in relation to no movement at all and the capacity of the BCI to distinguish between these conditions.

Official Title
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A Novel BCI-controlled Pneumatic Glove System for Neurorehabilitation Post-stroke

Conditions
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Poststroke/CVA Hemiparesis, Paralytic Stroke, Hand Flaccid Paralysis

Intervention / Treatment
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* Device: EEG based Brain Computer Interface


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 6 months post-stroke (chronic), unilateral > 18 yrs little to no hand movement spasticity < 3 on modified Ashworth Scale Exclusion Criteria: major cognitive deficits (Folstein mini mental status > 23 strong hemi-neglect (Catherine Bergego scale > 15/30)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chronic post-stroke<br>Patients >6 months post-stroke with little to no hand movement. use of EEG based BCI in the neurorehabilitation process | Device: EEG based Brain Computer Interface<br>* Using EEG signals to classify brain activity being 'rest' or 'active' to control the attached pneumatic glove and close the sensory-motor loop between intentional/mental movement and physical (though passive) movement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of the BCI-system (evaluation of performance through patient questionaires & the performance of the BCI classifier during intended and imagined hand movements) | Evaluation of the BCI-platform performance through patient questionnaires & the performance of the BCI classifier during intended and imagined hand movements. | During the whole study. Assesment is made for each patient after his participation ( 2 hours). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG sensory-motor rhythm signals (Detailed analysis of the EEG signals in relation to the severity of the paresis and movement condition) | Detailed analysis of the EEG signals in relation to the severity of the paresis and movement condition | During the whole studyAssesment is made for each patient after his participation ( 2 hours). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reeducation, BCI, Post stroke, Hand movement