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BCI Post-stroke Neurorehabilitation (BCI-stroke)

Primary Purpose

Poststroke/CVA Hemiparesis, Paralytic Stroke, Hand Flaccid Paralysis

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

EEG based Brain Computer Interface

About this trial

This is an interventional basic science trial for Poststroke/CVA Hemiparesis focused on measuring Post stroke, BCI, Reeducation, Hand movement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

CHRU Lapeyronie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chronic post-stroke

Arm Description

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT02404857

First Posted

January 12, 2015

Last Updated

November 23, 2015

Sponsor

University Hospital, Montpellier

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02404857

Brief Title

BCI Post-stroke Neurorehabilitation

Acronym

BCI-stroke

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Poststroke/CVA Hemiparesis, Paralytic Stroke, Hand Flaccid Paralysis

Keywords

Post stroke, BCI, Reeducation, Hand movement

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chronic post-stroke

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

EEG based Brain Computer Interface

Intervention Description

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 Outcome Measure Information:

Title

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

Description

Evaluation of the BCI-platform performance through patient questionnaires & 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).

Secondary Outcome Measure Information:

Title

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

Description

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).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Liesjet Van Dokkum, PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHRU Lapeyronie

City

Montpellier

State/Province

Herault

ZIP/Postal Code

34295

Country

France

12. IPD Sharing Statement

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BCI Post-stroke Neurorehabilitation

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