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Completed

NCT Number: NCT02404857

BCI Post-stroke Neurorehabilitation

The goal is to evaluate the potential of a EEG based BCI (Brain-Computer-Interface) connected to a non-invasive pneumatic glove for rehabilitation of hand-movements post-stroke.

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Key information

Conditions

Poststroke/CVA Hemiparesis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hand Flaccid Paralysis Nervous System Diseases Paralytic Stroke Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Lapeyronie

Montpellier, Herault, 34295, France

About this study

Brain computer interfaces (BCI) encompasses the usage of the brain signals to compensate for lost physical function. The current protocol evaluates the therapeutic potential of a EEG based driven BCI that is connected to a non-invasive pneumatic glove for rehabilitation of hand flexion/extension post-stroke. The system non-invasive, portable and low-cost. The utility and usability of the system will be investigated at two levels. First by means of questionnaires for patients and therapist and second by means of in depth analysis of the EEG signals during intended, imagined and passive driven hand movements in relation to no movement at all and the capacity of the BCI to distinguish between these conditions.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • > 6 months post-stroke (chronic), unilateral
  • > 18 yrs
  • little to no hand movement
  • spasticity < 3 on modified Ashworth Scale

Exclusion criteria

  • major cognitive deficits (Folstein mini mental status > 23
  • strong hemi-neglect (Catherine Bergego scale > 15/30)

Treatment and study plan

EEG based Brain Computer Interface

Device

Using EEG signals to classify brain activity being 'rest' or 'active' to control the attached pneumatic glove and close the sensory-motor loop between intentional/mental movement and physical (though passive) movement.

Primary outcomes

  1. Performance of the BCI-system (evaluation of performance through patient questionaires & the performance of the BCI classifier during intended and imagined hand movements)

    Time frame: During the whole study. Assesment is made for each patient after his participation ( 2 hours).

    Evaluation of the BCI-platform performance through patient questionnaires & the performance of the BCI classifier during intended and imagined hand movements.

Secondary outcomes

  1. EEG sensory-motor rhythm signals (Detailed analysis of the EEG signals in relation to the severity of the paresis and movement condition)

    Time frame: During the whole studyAssesment is made for each patient after his participation ( 2 hours).

    Detailed analysis of the EEG signals in relation to the severity of the paresis and movement condition

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Centre Hospitalier Universitaire de Nīmes
  • National University of Ireland, Maynooth
  • Université Montpellier

Registry information

Official study title

A Novel BCI-controlled Pneumatic Glove System for Neurorehabilitation Post-stroke

Acronym: BCI-stroke

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 1, 2015
Registry last updated
Nov 24, 2015

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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