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BCI Post-stroke Neurorehabilitation

NCT ID: NCT02404857

Last Updated: 2015-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Poststroke/CVA Hemiparesis Paralytic Stroke Hand Flaccid Paralysis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Chronic post-stroke

Patients \>6 months post-stroke with little to no hand movement. use of EEG based BCI in the neurorehabilitation process

Group Type EXPERIMENTAL

EEG based Brain Computer Interface

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Université Montpellier

OTHER

Sponsor Role collaborator

National University of Ireland, Maynooth

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Liesjet Van Dokkum, PhD

Role: PRINCIPAL_INVESTIGATOR

CHRU Montpellier, Lapeyronie // Euromov-M2H, Montpellier University

Locations

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CHRU Lapeyronie

Montpellier, Herault, France

Site Status

Countries

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France

Other Identifiers

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9431

Identifier Type: -

Identifier Source: org_study_id