Hybrid Brain Computer Interface for Control of Sensory - Motor Coupling in Post - Stroke Rehabilitation

Study Overview
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Brief Summary
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HYBIS project aims to develop an innovative and unique hybrid Brain-Computer Interface (BCI) system. This BCI system is envisioned as a novel tool for targeted reinforcement of sensory motor coupling, specifically dedicated for upper-limb post-stroke rehabilitation.

Official Title
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Feasibility Clinical Study of a Novel Hybrid Brain Computer Interface for Control of Sensory-motor Coupling in Post-stroke Rehabilitation

Conditions
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Stroke

Intervention / Treatment
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* Device: BCI feasibility test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age over 18 years old at the time of enrolment history of cerebrovascular insult verified by computerized tomography or magnetic resonance imaging; stoke occurred not more than 6 months prior to study enrolment; subject need to be medically and neurologically stable determined by medical history and documented neurological examination; ability to understand, communicate and cooperate with the research team; ability to sit for at least 45 minutes and the ability to adhere to the study rehabilitation protocol. Exclusion Criteria: any neurologic condition (beyond the stroke) or physical condition that impaired function of the affected arm a substantial cardiopulmonary or metabolic disorder or other major medical complication; history of seizures; moderate to severe hemispatial neglect or anosognosia involving the affected arm; severe sensory deficit; inability to understand, cooperate, and adhere to the study procedures; severe spasticity defined as Ashworth scale score of 4 in the affected arm; contraindication to stimulation system placement; nursing a child; pregnancy.

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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stroke patients<br>Experimental group of stroke survivors for testing the feasibility of a BCI system | Device: BCI feasibility test<br>* Testing the feasibility of BCI device by determining the accuracy of BCI control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrotactile BCI system accuracy | Electrotactile BCI system accuracy is a measure of feasibility of the prototype device. Accuracy [0 -100 %] of classification of user's mental strategy (tactile attention task towards one of the two electrical stimulation hotspots), where higher values of accuracy are related to better system control. | within 30 minutes after experimental session | 
| Motor Imagery BCI system accuracy | Motor Imagery BCI system accuracy is a measure of feasibility of the prototype device. Accuracy [0 - 100 %] of classification between rest and imaginary movement in a cue-based manner, , where higher values of accuracy are related to better system control. | within 30 minutes after experimental session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl Meyer sensory score for upper extremity | Fugl Meyer sensory score for upper extremity assesses the degree of sensory impairment in the upper arm. Sensation score ranges from 0 to 12 points, divided into 4 points for light touch and 12 points for position sense. Individual items pertaining to the light touch sensation of the upper arm/ forearm and palmary surface of the hand and to the position of the shoulder/ elbow/ wrist/ thumb (IP-joint) are scored on a 3-point ordinal scale and summed for a maximum possible score of 12. The higher score is considered to represent a less sensory deficit of the subject | immediately after experimental session | 
| NASA-TLX | NASA Task Load Index (NASA-TLX) method assesses workload on six scales for different aspects: mental demand, physical demand, temporal demand, performance, effort, and frustration on a 21-point scale. A higher rating represents higher workload. | within 30 minutes after experimental session |