StrokeHYBISNCT05152108
Hybrid Brain Computer Interface for Control of Sensory - Motor Coupling in Post - Stroke Rehabilitation
A study testing BCI feasibility test in people with Stroke, run by University of Belgrade at 1 site in Serbia.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- BCI feasibility test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Apr 2022to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- severe spasticity defined as Ashworth scale score of 4 in the affected arm;
- contraindication to stimulation system placement;
- nursing a child;
- pregnancy.
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade
Belgrade, 11000
About this study
Official title: Feasibility Clinical Study of a Novel Hybrid Brain Computer Interface for Control of Sensory-motor Coupling in Post-stroke Rehabilitation
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
- Being tested
- BCI feasibility test
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCI feasibility testDevice
Testing the feasibility of BCI device by determining the accuracy of BCI control
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | Experimental | Experimental group of stroke survivors for testing the feasibility of a BCI system Receives: Device: BCI feasibility test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: within 30 minutes after experimental session
Secondary outcomes (2)
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
Measured: immediately after experimental session
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.
Measured: within 30 minutes after experimental session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Apr 2022
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinovic Ljubica, University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152108
- Sponsor's protocol ID
- 6066223
- Acronym
- HYBIS
- Status last verified
- Dec 2024
- First submitted
- 13 Nov 2021
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Clinical Study of a Novel Hybrid Brain Computer Interface for Control of Sensory-motor Coupling in Post-stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT05152108
- Acronym / sponsor ID
- HYBIS / 6066223
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | Experimental | Device: BCI feasibility testExperimental group of stroke survivors for testing the feasibility of a BCI system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCI feasibility testTesting the feasibility of BCI device by determining the accuracy of BCI control | Device | Stroke patients |
Primary outcome
Electrotactile BCI system accuracy
Time frame: 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
Time frame: 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.
2 secondary outcomes
Fugl Meyer sensory score for upper extremity
Time frame: immediately after experimental session
NASA-TLX
Time frame: within 30 minutes after experimental session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCI feasibility test in people with Stroke, run by University of Belgrade at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrotactile BCI system accuracy (time frame: within 30 minutes after experimental session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.