Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-01 @ 4:14 AM
Study NCT ID:
NCT03381456
Status:
COMPLETED
Last Update Posted:
2017-12-22
First Post:
2017-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Task-dependent Operation of a Mechanism Intracortical Inhibition in Dystonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020821', 'term': 'Dystonic Disorders'}], 'ancestors': [{'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '10 patient with dystonia and 10 healthy subject paired by sex and age.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-18', 'studyFirstSubmitDate': '2017-12-18', 'studyFirstSubmitQcDate': '2017-12-18', 'lastUpdatePostDateStruct': {'date': '2017-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'long-interval intracortical inhibition (LICI) level', 'timeFrame': 'Baseline', 'description': 'Amount of inhibition at interstimulus intervals of between 50 to 300ms'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dystonia, Primary']}, 'descriptionModule': {'briefSummary': 'Cortical excitability depends on inhibitory mechanisms efficiency among which long latency intracortical inhibition (LICI) can be studied by paired pulses transcranial magnetic stimulation (TMS). Some recent evidences suggest that LICI may be one of the mechanisms by which the motor comment is adapted to the ongoing motor task with LICI strength being dependent on task complexity. In writer cramp and musician cramp, two forms of dystonia, the cortical excitability is not correctly modulated in some complex gestures. the hypothesis is that this task dependent perturbation of excitability in writer cramp could be due to a lack of LICI efficiency.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with hand dystonia : writers cramp\n* Subject affiliated to social security regimen.\n\nFor healthy volunteers :\n\n* Healthy volunteer without neurological disorders based on sensorimotor examination.\n* Subject affiliated to social security regimen.\n\nExclusion Criteria :\n\n* Subject unable to receive informed consent (dementia).\n* Contraindication to Transcranial Magnetic Stimulation(TMS) (epilepsia, intracranial metalic foreign object, hearing device, cochlear implant).\n* Patient using a psychotrope treatment.\n* Patient under guardianship or curatorship.\n* Pregnant or nursing women.\n* Patient with a cardiac stimulator.\n\nFor healthy volunteers only :\n\n• Abnormal neurological evaluation based on sensorimotor examination or neurological history ( epilepsy, stroke ; brain or spinal cord surgery ; history of neurological disease affective sensitive and motor control)'}, 'identificationModule': {'nctId': 'NCT03381456', 'acronym': 'LICIdystonie', 'briefTitle': 'Task-dependent Operation of a Mechanism Intracortical Inhibition in Dystonia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Task-dependent Operation of a Mechanism Intracortical Inhibition in Dystonia', 'orgStudyIdInfo': {'id': '2013_51'}, 'secondaryIdInfos': [{'id': '2014-A00244-43', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy subject', 'description': 'LICI', 'interventionNames': ['Other: LICI']}, {'type': 'EXPERIMENTAL', 'label': 'Dystonic subject', 'description': 'LICI', 'interventionNames': ['Other: LICI']}], 'interventions': [{'name': 'LICI', 'type': 'OTHER', 'description': 'Paired pulse TMS to measure LICI and late cortical disinhibition', 'armGroupLabels': ['Dystonic subject', 'Healthy subject']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Roger Salengro, CHRU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Philippe Derambure, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}