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

Stroke Clinical Trial

— HYBIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05152108
• Other study ID #: 6066223
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: December 15, 2025

Study information

• Verified date: November 2023
• Source: University of Belgrade
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 15, 2025
• Est. primary completion date: July 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• BCI feasibility test
Testing the feasibility of BCI device by determining the accuracy of BCI control

Locations

Country	Name	City	State
Serbia	Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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