Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2026-01-28 @ 9:05 PM
Study NCT ID:
NCT02927002
Status:
UNKNOWN
Last Update Posted:
2017-10-09
First Post:
2016-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Non-invasive Brain Stimulation in Impulse Control Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007174', 'term': 'Disruptive, Impulse Control, and Conduct Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-06', 'studyFirstSubmitDate': '2016-05-17', 'studyFirstSubmitQcDate': '2016-10-05', 'lastUpdatePostDateStruct': {'date': '2017-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in decision-making from pre to post stimulation assessed with the Balloon Analogue Risk Task', 'timeFrame': '10 minutes before and immediately after the 30 minutes of non invasive brain stimulation'}], 'secondaryOutcomes': [{'measure': 'Changes in brain activity assessed between before and during stimulation measured with functional magnetic resonance (fMRI)', 'timeFrame': '20 minutes before and immediately after the 30 minutes of non invasive brain stimulation'}, {'measure': 'Neural metabolites concentrations measured with magnetic resonance spectroscopy (MRS)', 'timeFrame': '20 minutes before and immediately after the 30 minutes of non invasive brain stimulation'}, {'measure': 'Change in Craving from pre to post stimulation assessed with a single standardized scale', 'timeFrame': '7 minutes before and 3 minutes after the end of the 30 minutes of non invasive brain stimulation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Impulse Control Disorder']}, 'descriptionModule': {'briefSummary': 'The goal of this project is to study the effect of noninvasive brain stimulation on decision-making and on brain activity in impulse control disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Impulse control disorders according to DSM-IV criteria\n\nExclusion Criteria:\n\n* Other psychiatric disorders\n* Contraindication to Non-invasive brain stimulation and MRI'}, 'identificationModule': {'nctId': 'NCT02927002', 'briefTitle': 'Effects of Non-invasive Brain Stimulation in Impulse Control Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Effects of Non-invasive Brain on Decision-making in Impulse Control Disorders', 'orgStudyIdInfo': {'id': '2014-374'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Noninvasive brain stimulation: active', 'description': 'In active condition, subject will receive stimulation during all the 30-minute stimulation period', 'interventionNames': ['Device: Noninvasive brain stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Noninvasive brain: sham', 'description': 'In sham condition, subject will receive stimulation only at the beginning and at the end of 30-minute stimulation period.', 'interventionNames': ['Device: Noninvasive brain stimulation']}], 'interventions': [{'name': 'Noninvasive brain stimulation', 'type': 'DEVICE', 'armGroupLabels': ['Noninvasive brain stimulation: active', 'Noninvasive brain: sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1M2S8', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Interdisciplinaire de Recherche en Réadaptation et Intégration', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}