Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-13 @ 9:43 AM
Study NCT ID:
NCT02404857
Status:
COMPLETED
Last Update Posted:
2015-11-24
First Post:
2015-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BCI Post-stroke Neurorehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-23', 'studyFirstSubmitDate': '2015-01-12', 'studyFirstSubmitQcDate': '2015-03-26', 'lastUpdatePostDateStruct': {'date': '2015-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance of the BCI-system (evaluation of performance through patient questionaires & the performance of the BCI classifier during intended and imagined hand movements)', 'timeFrame': 'During the whole study. Assesment is made for each patient after his participation ( 2 hours).', 'description': 'Evaluation of the BCI-platform performance through patient questionnaires \\& the performance of the BCI classifier during intended and imagined hand movements.'}], 'secondaryOutcomes': [{'measure': 'EEG sensory-motor rhythm signals (Detailed analysis of the EEG signals in relation to the severity of the paresis and movement condition)', 'timeFrame': 'During the whole studyAssesment is made for each patient after his participation ( 2 hours).', 'description': 'Detailed analysis of the EEG signals in relation to the severity of the paresis and movement condition'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Post stroke', 'BCI', 'Reeducation', 'Hand movement'], 'conditions': ['Poststroke/CVA Hemiparesis', 'Paralytic Stroke', 'Hand Flaccid Paralysis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 6 months post-stroke (chronic), unilateral\n* \\> 18 yrs\n* little to no hand movement\n* spasticity \\< 3 on modified Ashworth Scale\n\nExclusion Criteria:\n\n* major cognitive deficits (Folstein mini mental status \\> 23\n* strong hemi-neglect (Catherine Bergego scale \\> 15/30)'}, 'identificationModule': {'nctId': 'NCT02404857', 'acronym': 'BCI-stroke', 'briefTitle': 'BCI Post-stroke Neurorehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'A Novel BCI-controlled Pneumatic Glove System for Neurorehabilitation Post-stroke', 'orgStudyIdInfo': {'id': '9431'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chronic post-stroke', 'description': 'Patients \\>6 months post-stroke with little to no hand movement. use of EEG based BCI in the neurorehabilitation process', 'interventionNames': ['Device: EEG based Brain Computer Interface']}], 'interventions': [{'name': 'EEG based Brain Computer Interface', 'type': 'DEVICE', '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.", 'armGroupLabels': ['Chronic post-stroke']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'state': 'Herault', 'country': 'France', 'facility': 'CHRU Lapeyronie', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Liesjet Van Dokkum, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU Montpellier, Lapeyronie // Euromov-M2H, Montpellier University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'collaborators': [{'name': 'Université Montpellier', 'class': 'OTHER'}, {'name': 'National University of Ireland, Maynooth', 'class': 'OTHER'}, {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}