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

Sponsor
University of Belgrade (Other)
Overall Status
Recruiting
CT.gov ID
NCT05152108
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
8.5
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: BCI feasibility test
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
Feasibility Clinical Study of a Novel Hybrid Brain Computer Interface for Control of Sensory-motor Coupling in Post-stroke Rehabilitation
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Jul 15, 2022
Anticipated Study Completion Date :
Dec 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Stroke patients

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

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade Belgrade Serbia 11000

Sponsors and Collaborators

  • University of Belgrade

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Konstantinovic Ljubica, Professor, University of Belgrade
ClinicalTrials.gov Identifier:
NCT05152108
Other Study ID Numbers:
  • 6066223
First Posted:
Dec 9, 2021
Last Update Posted:
May 24, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Stroke

Study Results

No Results Posted as of May 24, 2022