Hybrid Brain Computer Interface for Control of Sensory - Motor Coupling in Post - Stroke Rehabilitation (HYBIS)
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
BCI feasibility test
Sponsored by
About this trial
This is an interventional device feasibility trial for Stroke
Eligibility Criteria
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.
Sites / Locations
- Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of BelgradeRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stroke patients
Arm Description
Experimental group of stroke survivors for testing the feasibility of a BCI system
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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
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.
Full Information
NCT ID
NCT05152108
First Posted
November 13, 2021
Last Updated
October 31, 2022
Sponsor
University of Belgrade
1. Study Identification
Unique Protocol Identification Number
NCT05152108
Brief Title
Hybrid Brain Computer Interface for Control of Sensory - Motor Coupling in Post - Stroke Rehabilitation
Acronym
HYBIS
Official Title
Feasibility Clinical Study of a Novel Hybrid Brain Computer Interface for Control of Sensory-motor Coupling in Post-stroke Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
July 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Belgrade
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stroke patients
Arm Type
Experimental
Arm Description
Experimental group of stroke survivors for testing the feasibility of a BCI system
Intervention Type
Device
Intervention Name(s)
BCI feasibility test
Intervention Description
Testing the feasibility of BCI device by determining the accuracy of BCI control
Primary Outcome Measure Information:
Title
Electrotactile BCI system accuracy
Description
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.
Time Frame
within 30 minutes after experimental session
Title
Motor Imagery BCI system accuracy
Description
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.
Time Frame
within 30 minutes after experimental session
Secondary Outcome Measure Information:
Title
Fugl Meyer sensory score for upper extremity
Description
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
Time Frame
immediately after experimental session
Title
NASA-TLX
Description
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.
Time Frame
within 30 minutes after experimental session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ljubica M Konstantinovic, PhDMD
Phone
+381112061513
Email
ljubica.konstantinovic@med.bg.ac.rs
12. IPD Sharing Statement
Learn more about this trial
Hybrid Brain Computer Interface for Control of Sensory - Motor Coupling in Post - Stroke Rehabilitation
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