Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-02-20 @ 6:03 PM
Study NCT ID:
NCT01540305
Status:
COMPLETED
Last Update Posted:
2012-02-28
First Post:
2012-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Transcranial Magnetic Stimulation for Treatment of Obsessive-Compulsive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-27', 'studyFirstSubmitDate': '2012-02-15', 'studyFirstSubmitQcDate': '2012-02-27', 'lastUpdatePostDateStruct': {'date': '2012-02-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Y-BOCS scale scores relative to baseline', 'timeFrame': 'assessments were at baseline, at 2 weeks and at 3 months', 'description': 'Y-BOCS: Yale-Brown Obsessive-Compulsive Scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obsessive Compulsive Disorder', 'Transcranial Magnetic Stimulation', 'Treatment'], 'conditions': ['Obsessive Compulsive Disorder']}, 'referencesModule': {'references': [{'pmid': '19691873', 'type': 'BACKGROUND', 'citation': 'Mantovani A, Simpson HB, Fallon BA, Rossi S, Lisanby SH. Randomized sham-controlled trial of repetitive transcranial magnetic stimulation in treatment-resistant obsessive-compulsive disorder. Int J Neuropsychopharmacol. 2010 Mar;13(2):217-27. doi: 10.1017/S1461145709990435. Epub 2009 Aug 20.'}, {'pmid': '15982444', 'type': 'BACKGROUND', 'citation': "Mantovani A, Lisanby SH, Pieraccini F, Ulivelli M, Castrogiovanni P, Rossi S. Repetitive transcranial magnetic stimulation (rTMS) in the treatment of obsessive-compulsive disorder (OCD) and Tourette's syndrome (TS). Int J Neuropsychopharmacol. 2006 Feb;9(1):95-100. doi: 10.1017/S1461145705005729. Epub 2005 Jun 28."}]}, 'descriptionModule': {'briefSummary': 'This study aimed at verifying whether sessions of repetitive transcranial magnetic stimulation over a certain brain area (the supplementary motor area) could be useful in the relief of Obsessive-Compulsive Disorder symptoms.', 'detailedDescription': 'Patients were randomly administered either real (n = 12) or sham (n = 10) rTMS, once a day, 5 days a week, for 2 weeks. Randomization was performed according to a computer-generated schedule. Subjects and scale-rater physician were blind to treatment status of individuals. Only the rTMS administrator was aware of group allocations. Treatment response was assessed by self-and clinician-rated scales before treatment, immediately after treatment and 3 months thereafter, with the same examiner following a subject throughout the study. All patients included in the study had failed adequate pharmacological treatment for at least 2 antiobsessional drugs. Their prescription drugs were continued without change in dosage regimens throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 to 60 years\n* diagnosis of obsessive-compulsive disorder (OCD) according to DSM-IV-TR criteria and having OCD of at least moderate severity (YBOCS score of 16 or above).\n\nExclusion Criteria:\n\n* subjects with comorbid psychiatric disorders (except depression - HAM-D ) or history of drug abuse\n* significant head injury, or of any neurosurgical procedure\n* pregnant women\n* patients with metal implants or illnesses that prevent attendance to sessions\n* patients with a history of seizure or bearing pacemakers'}, 'identificationModule': {'nctId': 'NCT01540305', 'briefTitle': 'Efficacy Study of Transcranial Magnetic Stimulation for Treatment of Obsessive-Compulsive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Brasilia'}, 'officialTitle': 'A Randomized Double-blind Trial of Repetitive Transcranial Magnetic Stimulation in Obsessive -Compulsive Disorder With Three Months Follow-up', 'orgStudyIdInfo': {'id': '49/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Transcranial Magnetic Stimulation', 'description': 'Actual transcranial magnetic stimulation of supplementary motor areas bilaterally.', 'interventionNames': ['Device: Repetitive Transcranial Magnetic Stimulation (rTMS)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Transcranial Magnetic Stimulation', 'description': 'Sham transcranial magnetic stimulation over the supplementary motor areas.', 'interventionNames': ['Device: Sham repetitive transcranial magnetic stimulation']}], 'interventions': [{'name': 'Repetitive Transcranial Magnetic Stimulation (rTMS)', 'type': 'DEVICE', 'otherNames': ['Neuro-MS Transcranial Magnetic Stimulator'], 'description': 'rTMS was administered by means of a NEURO-MS (NEUROSOFT LTD®, Russia) with a focal 8-shaped 70 mm coil. Stimulation parameters were 1-Hz, 20-min trains (1200 pulses/day) at 100% of resting MT, once a day, 5 days a week, for 2 weeks.', 'armGroupLabels': ['Transcranial Magnetic Stimulation']}, {'name': 'Sham repetitive transcranial magnetic stimulation', 'type': 'DEVICE', 'otherNames': ['Neurosoft sham coil'], 'description': 'The sham treatment was performed using the Neurosoft ® sham coil. A metal plate placed inside this coil prevents the magnetic field from stimulating the cortex. This coil looks and sounds like an active coil.', 'armGroupLabels': ['Sham Transcranial Magnetic Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70000-000', 'city': 'Brasília', 'state': 'Federal District', 'country': 'Brazil', 'facility': 'Laboratory of Neurosciences and Behavior, Biology Institute, University of Brasília', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}], 'overallOfficials': [{'name': 'Joaquim Brasil-Neto, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Brasilia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Brasilia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Joaquim Brasil-Neto', 'investigatorAffiliation': 'University of Brasilia'}}}}