Brain Computer Interface Training After Stroke

Study Overview
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Brief Summary
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In this study, we want to examine the effect of a new treatment approach for patients with severe upper limb paresis in the subacute phase after stroke. Brain Computer Interface (BCI) driven functional electrical stimulation will be compared to conventional training.

Detailed Description
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A randomized controlled pilot study will be conducted. Forty patients with severe UL paresis will be included. Patients with severe hemiparesis after stroke will be allocated to one of two treatment groups by a computerized randomization program. Patients in the intervention group will receive training with a BCI system paired with functional electrical stimulation and visual feedback (RecoveriX, gtec, Austria) as part of their rehabilitation. The targeted number of training sessions in the intervention group is 12. Patients in the control group will receive conventional upper limb training. All patients will receive other rehabilitation according to their needs. Patients will be assessed by blinded raters before and after the intervention and 3 months post stroke. Main endpoint will be UL motor function assessed by Action Research Arm Test (ARAT) at 3 months post stroke. Other outcome measures comprise Fugl Meyer Motor Assessment and Functional Independence Measure. The patients and therapists' experience with this type of training will be evaluated with questionnaires and interviews.

Official Title
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Brain Computer Interface Training for Patients With Severe Upper Limb Paresis in the Subacute Phase After Stroke

Conditions
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Stroke

Intervention / Treatment
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* Device: Brain Computer Interface training
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First ever or former stroke without UL motor residuals as confirmed by CT and / or MRI 15 days to 60 days (+/- 3) after stroke onset Severe paresis or paralysis defined as < 13 on Action Research arm Test (ARAT) Able to give informed consent Able to comply with treatment protocol. Exclusion Criteria: Other conditions limiting functional use of the affected UL, Psychiatric / behavioral conditions that interfere with compliance to the protocol, epilepsy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients are randomized to one of two treatment options, intervention or standard rehabilitation
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BCI training<br>Patients randomized to this group will receive up to12 (minimum 8) sessions of BCI training with the RecoveriX system (gtec, Austria). The system combines EEG driven functional electrical stimulation with visual feedback. BCI training is provided as a part of standard training of the impaired upper limb. | Device: Brain Computer Interface training<br>* Training with RecoveriX system.<br>|
| Active Comparator: Control<br>Patients randomized to this control group will receive standard physiotherapy and occupational therapy for their impaired upper limb. | Behavioral: Control<br>* Standard physiotherapy and occupational therapy according to clinical routines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Action Research Arm Test (ARAT) | Upper limb function on a scale of 0 - 57 (best) | Upper limb function 90 days after stroke | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment (UL) | Upper limb impairment on a scale from 0-66 (best) | Upper limb impairment 90 days after stroke | 
| Functional Independence Measure | Independence in activities og daily living, 18-126 (best) | Functional independence 90 days after stroke | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BCI, upper limb, severe paresis, subacute stroke, rehabilitation