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BCI Post-stroke Neurorehabilitation (BCI-stroke)

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ClinicalTrials.gov Identifier: NCT02404857
Recruitment Status : Completed
First Posted : April 1, 2015
Last Update Posted : November 24, 2015
Sponsor:
Collaborators:
Université Montpellier
National University of Ireland, Maynooth
Centre Hospitalier Universitaire de Nīmes
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Poststroke/CVA Hemiparesis Paralytic Stroke Hand Flaccid Paralysis Device: EEG based Brain Computer Interface Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Novel BCI-controlled Pneumatic Glove System for Neurorehabilitation Post-stroke
Study Start Date : January 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02404857


Locations
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France
CHRU Lapeyronie
Montpellier, Herault, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Université Montpellier
National University of Ireland, Maynooth
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Liesjet Van Dokkum, PhD CHRU Montpellier, Lapeyronie // Euromov-M2H, Montpellier University
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02404857    
Other Study ID Numbers: 9431
First Posted: April 1, 2015    Key Record Dates
Last Update Posted: November 24, 2015
Last Verified: November 2015
Keywords provided by University Hospital, Montpellier:
Post stroke
BCI
Reeducation
Hand movement
Additional relevant MeSH terms:
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Stroke
Paralysis
Paresis
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations