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Active, Not Recruiting

NCT Number: NCT05152108

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Belgrade, 11000, Serbia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BCI feasibility test

Device

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Fugl Meyer sensory score for upper extremity

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Belgrade

Other

Registry information

Official study title

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

Acronym: HYBIS

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2021
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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