Stroke
Conditions
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.
Interventions
DEVICEBCI feasibility test
Testing the feasibility of BCI device by determining the accuracy of BCI control
Sponsors
University of Belgrade
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Serbia
Outcome results
None listed