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NCT05152108Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 9 Dec 2024

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
10 (estimated)
First submitted
13 Nov 2021
Start date
1 Apr 2022
Primary completion date
15 Jul 2025
Lead sponsor
University of Belgrade
Diseases
Stroke
NCT number
NCT05152108

What you commit to

  • Study type: Interventional
  • Planned participants: 10
  • From 1 Apr 2022 to the primary completion date, 15 Jul 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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;

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade
Coordinator of this site? Confirm its status
BelgradeSerbiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.