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

U

University of Belgrade

Status

Active, not recruiting

Conditions

Stroke

Treatments

Device: BCI feasibility test

Study type

Interventional

Funder types

Other

Identifiers

NCT05152108
6066223

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Device Feasibility

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Stroke patients
Experimental group
Description:
Experimental group of stroke survivors for testing the feasibility of a BCI system
Treatment:
Device: BCI feasibility test

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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