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

NCT05152108 | Active Not Recruiting

• 1 other identifier: 6066223
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Fugl Meyer sensory score for upper extremity

  immediately after experimental session

• NASA-TLX

  within 30 minutes after experimental session

Study Arms (1)

Stroke patients

EXPERIMENTAL

Experimental group of stroke survivors for testing the feasibility of a BCI system

Device: BCI feasibility test

Interventions

BCI feasibility test DEVICE

Testing the feasibility of BCI device by determining the accuracy of BCI control

Stroke patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Belgrade: lead

Study Sites (1)

Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade

Belgrade, 11000, Serbia

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 13, 2021
• First Posted: December 9, 2021
• Study Start: April 1, 2022
• Primary Completion: July 15, 2025
• Study Completion: December 15, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

SE (1)