BCI Post-stroke Neurorehabilitation (BCI-stroke)
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| ClinicalTrials.gov Identifier: NCT02404857 |
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Recruitment Status :
Completed
First Posted : April 1, 2015
Last Update Posted : November 24, 2015
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Sponsor:
University Hospital, Montpellier
Collaborators:
Université Montpellier
National University of Ireland, Maynooth
Centre Hospitalier Universitaire de Nīmes
Information provided by (Responsible Party):
University Hospital, Montpellier
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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 |
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 (Clinical Trial) |
| Actual Enrollment : | 20 participants |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Chronic post-stroke
Patients >6 months post-stroke with little to no hand movement. use of EEG based BCI in the neurorehabilitation process
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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. |
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) [ 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 :
- 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
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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)
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
| 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
| Principal Investigator: | Liesjet Van Dokkum, PhD | CHRU Montpellier, Lapeyronie // Euromov-M2H, Montpellier University |
| Responsible Party: | University Hospital, Montpellier |
| ClinicalTrials.gov Identifier: | NCT02404857 History of Changes |
| 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:
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Post stroke BCI Reeducation Hand movement |
Additional relevant MeSH terms:
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Brain Diseases Stroke Paralysis Paresis Cerebrovascular Disorders Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Neurologic Manifestations Signs and Symptoms |