Hybrid Brain Computer Interface for Control of Sensory - Motor Coupling in Post - Stroke Rehabilitation
- Conditions
- Stroke
- Interventions
- Device: BCI feasibility test
- Registration Number
- NCT05152108
- Lead Sponsor
- University of Belgrade
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 10
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Stroke patients BCI feasibility test Experimental group of stroke survivors for testing the feasibility of a BCI system
- Primary Outcome Measures
Name Time Method Electrotactile BCI system accuracy within 30 minutes after experimental session 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.
Motor Imagery BCI system accuracy within 30 minutes after experimental session 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.
- Secondary Outcome Measures
Name Time Method Fugl Meyer sensory score for upper extremity immediately after experimental session 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
NASA-TLX within 30 minutes after experimental session 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.
Trial Locations
- Locations (1)
Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade
🇷🇸Belgrade, Serbia