Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-04 @ 6:15 AM
Study NCT ID:
NCT03379532
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2017-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BCI-controlled NMES in Subacute Stroke
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2017-12-14', 'studyFirstSubmitQcDate': '2017-12-14', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Upper Limb Fugl-Meyer Score, follow up', 'timeFrame': 'Difference between the week before intervention and 12 weeks after stroke onset', 'description': 'Scale 0-66, higher scores indicate better outcome'}, {'measure': 'Change in hand grip strength, after intervention', 'timeFrame': 'Difference between the week before the intervention and the week after intervention', 'description': 'Jamar dynamometer. Continous measure expressed in kilograms. Higher values indicate better outcome.'}, {'measure': 'Change in hand grip strength, follow up', 'timeFrame': 'Difference between the week before intervention and 12 weeks after stroke onset', 'description': 'Jamar dynamometer. Continous measure expressed in kilograms. Higher values indicate better outcome.'}, {'measure': 'Change in Functional Independence Measure (FIM) score, after intervention', 'timeFrame': 'Difference between the week before the intervention and the week after intervention', 'description': 'Range 18-126, higher values indicate better outcome.'}, {'measure': 'Change in Functional Independence Measure (FIM) score, follow up', 'timeFrame': 'Difference between the week before intervention and 12 weeks after stroke onset', 'description': 'Range 18-126, higher values indicate better outcome.'}, {'measure': 'Change in Semmes-Weinstein monofilament discrimination test, after intervention', 'timeFrame': 'Difference between the week before the intervention and the week after intervention', 'description': 'Range 0.04 to 60 g. Lower values indicate better outcome.'}, {'measure': 'Change in Semmes-Weinstein monofilament discrimination test, follow up', 'timeFrame': 'Difference between the week before intervention and 12 weeks after stroke onset', 'description': 'Range 0.04 to 60 g. Lower values indicate better outcome.'}, {'measure': 'Change in Modified Ashworth Score, after intervention', 'timeFrame': 'Difference between the week before the intervention and the week after intervention', 'description': 'Range 0 to 4. Lower values indicate better outcome.'}, {'measure': 'Change in Modified Ashworth Score, follow up', 'timeFrame': 'Difference between the week before intervention and 12 weeks after stroke onset', 'description': 'Range 0 to 4. Lower values indicate better outcome.'}, {'measure': 'Change in action research arm test (ARAT) score, after intervention', 'timeFrame': 'Difference between the week before the intervention and the week after intervention', 'description': 'Scale range 0-57 points, higher values indicate better outcome.'}, {'measure': 'Change in action research arm test (ARAT) score, follow up', 'timeFrame': 'Difference between the week before intervention and 12 weeks after stroke onset', 'description': 'Scale range 0-57 points, higher values indicate better outcome.'}], 'primaryOutcomes': [{'measure': 'Change in Upper Limb Fugl-Meyer Score, after treatment', 'timeFrame': 'Difference between the week before the intervention and the week after intervention', 'description': 'Scale 0-66, higher scores indicate better outcome'}], 'secondaryOutcomes': [{'measure': 'Change in motor evoked potential amplitude of the paretic arm', 'timeFrame': 'Difference between the week before the intervention and the week after intervention', 'description': 'Continuous measure, higher amplitude changes indicate better outcome'}, {'measure': 'Change in fractional anisotropy (FA) of the cortico-spinal tract as determined from diffusion tensor imaging', 'timeFrame': 'Difference between the week before the intervention and the week after intervention', 'description': 'FA can have values between 0 and 1, higher values indicate better outcome'}, {'measure': 'Change in electroencephalography functional connectivity', 'timeFrame': 'Difference between the week before the intervention and the week after intervention', 'description': 'Computed from high-density EEG recordings. Continuous measure. Higher values indicate better outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Stroke patients with severe upper limb movement deficits have limited treatment options and often remain severely handicapped at the chronic stage.\n\nRecent findings have suggested that poor motor recovery can be due to severe damage of the cortico-spinal tract (CST), the neural fibres connecting the movement regions of the brain to the spinal cord. Hence, to improve recovery of upper limb movements it will be crucial to re-establish and strengthen CST projections.\n\nRecent studies provided evidence that closed-loop brain computer interface-driven electrical stimulation of the paretic muscles can induce clinically important and lasting recovery of upper limb function, even in patients with chronic, severe motor affection. In this treatment approach, movement intentions of the patients are detected with electroencephalography and real-time analyses. This triggers an electrical stimulation of affected upper limb muscles.\n\nIn this study, the investigators hypothesize that neuromuscular electrical stimulation (NMES) applied contingent to voluntary activation of primary motor cortex, as detected by a brain-computer interface (BCI), can help restore CST projections. This might improve recovery of patients with severe upper limb movement deficits. Treatment will be started within the first 8 weeks after stroke onset.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ischemic or hemorrhagic stroke\n* Stroke onset ≤ 8 weeks\n* Severe, unilateral motor upper extremity hemiparesis (≤15 Fugl-Meyer Score)\n* Ability to give informed consent\n\nExclusion Criteria:\n\n* Second stroke during rehabilitation\n* Skull breach\n* Cardiac pacemaker\n* Metallic implants in the brain\n* Delirium or disturbed vigilance\n* Inability to follow treatments sessions\n* Severe language comprehension deficits\n* Severe dystonia or spasticity\n* Severe co-morbidity (ex, traumatic, rheumatologic, neurodegenerative diseases)\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03379532', 'briefTitle': 'BCI-controlled NMES in Subacute Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Brain-computer Interface Controlled Neuromuscular Electrical Stimulation in Subacute Stroke', 'orgStudyIdInfo': {'id': 'CRSII5-170985B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BCI-NMES', 'description': 'Electrical stimulation of paretic upper limb is triggered contigent to voluntary motor cortex activation of the patient, as detected by the brain-computer interface.', 'interventionNames': ['Device: BCI-NMES']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham-NMES', 'description': 'Electrical stimulation of paretic upper limb is applied independently of motor cortex activation of the patient by using a prerecorded session of another patient.', 'interventionNames': ['Device: Sham-NMES']}], 'interventions': [{'name': 'BCI-NMES', 'type': 'DEVICE', 'description': 'From the recorded brain activity (EEG) subject specific patterns will be extracted with machine learning techniques from recordings where the subject executes movements tasks. Whenever a subject-specific pattern can be identified and detected, this is used for triggering neuromuscular electrical stimulation.', 'armGroupLabels': ['BCI-NMES']}, {'name': 'Sham-NMES', 'type': 'DEVICE', 'description': "Neuromuscular electrical stimulation is triggered independently of the patient's movement intentions.", 'armGroupLabels': ['Sham-NMES']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78712', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '1211', 'city': 'Geneva', 'state': 'Canton of Geneva', 'country': 'Switzerland', 'facility': 'Division of Neurorehabilitation, University Hospital of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ecole Polytechnique Fédérale de Lausanne', 'class': 'OTHER'}, {'name': 'Clinique Romande de Readaptation', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Médecin adjoint agrégé, assistant professor', 'investigatorFullName': 'Adrian Guggisberg', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}