BCI Post-stroke Neurorehabilitation (BCI-stroke)

November 23, 2015 updated by: University Hospital, Montpellier

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Herault
      • Montpellier, Herault, France, 34295
        • CHRU Lapeyronie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chronic post-stroke
Patients >6 months post-stroke with little to no hand movement. use of EEG based BCI in the neurorehabilitation process
Device: EEG based Brain Computer Interface
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the whole study. Assesment is made for each patient after his participation ( 2 hours).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During the whole studyAssesment is made for each patient after his participation ( 2 hours).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

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

Investigators

  • Principal Investigator: Liesjet Van Dokkum, PhD, CHRU Montpellier, Lapeyronie // Euromov-M2H, Montpellier University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

March 26, 2015

First Posted (Estimate)

April 1, 2015

Study Record Updates

Last Update Posted (Estimate)

November 24, 2015

Last Update Submitted That Met QC Criteria

November 23, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9431 (Other Identifier: CTEP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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