Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-30 @ 6:54 PM
Study NCT ID:
NCT01076933
Status:
COMPLETED
Last Update Posted:
2017-05-11
First Post:
2010-01-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcranial Magnetic Stimulation for Borderline Personality Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001883', 'term': 'Borderline Personality Disorder'}], 'ancestors': [{'id': 'D010554', 'term': 'Personality 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-10', 'studyFirstSubmitDate': '2010-01-06', 'studyFirstSubmitQcDate': '2010-02-25', 'lastUpdatePostDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tower of London', 'timeFrame': 'Inclusion, 15th day, 30th day and 3rd month'}], 'secondaryOutcomes': [{'measure': 'Balloon Analog Risk Task', 'timeFrame': 'Inclusion, 15th day, 30th day and 3rd month'}, {'measure': 'Micro-World Test', 'timeFrame': 'Inclusion, 15th day and 3rd month'}, {'measure': 'Borderline Personality Disorder Severity Index', 'timeFrame': 'Pre-inclusion, 30th day and 3rd month'}, {'measure': 'Symptom Check List - 90', 'timeFrame': 'Inclusion, 15th day, 30th day and 3rd month'}, {'measure': 'Barratt Impulsivity Scale', 'timeFrame': 'Inclusion and 3rd month'}, {'measure': 'Global Assessment Scale', 'timeFrame': 'Inclusion and 3rd month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Borderline Personality Disorder', 'Transcranial Magnetic Stimulation', 'Neuropsychological Test', 'Randomised Control Trial'], 'conditions': ['Borderline Personality Disorder']}, 'referencesModule': {'references': [{'pmid': '24503285', 'type': 'RESULT', 'citation': 'Cailhol L, Roussignol B, Klein R, Bousquet B, Simonetta-Moreau M, Schmitt L, Thalamas C, Tap G, Birmes P. Borderline personality disorder and rTMS: a pilot trial. Psychiatry Res. 2014 Apr 30;216(1):155-7. doi: 10.1016/j.psychres.2014.01.030. Epub 2014 Jan 30.'}]}, 'descriptionModule': {'briefSummary': 'Primary purpose : to assess the effect on neuropsychological tasks related to planning of 10 daily sessions of right dorsolateral prefrontal cortex with High-frequency repetitive transcranial magnetic stimulation (rTMS) on borderline personality disorder (BPD) patients.\n\nHypothesis : BPD patients receiving 10 sessions of rTMS will have greater improvement in the average number of move to achieve tasks of the Tower of London, than those receiving sham rTMS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20 to 45 years old\n* Borderline Personality Disorder (Diagnostic Interview for Borderline Personality Disorder \\> 8)\n* psychiatric follow-up\n* righthander\n* informed consent\n* affiliated to medical insurance\n\nExclusion Criteria:\n\n* bipolar disorder\n* substance use disorder\n* Major Depressive Disorder or Stress Post Traumatic Disorder\n* history of epilepsy\n* neurosurgery\n* cardiac pacemaker\n* lefthander\n* involuntary admission\n* participation in an other research\n* legal guardianship\n* poor mastery of french.'}, 'identificationModule': {'nctId': 'NCT01076933', 'acronym': 'SiMaT-B', 'briefTitle': 'Transcranial Magnetic Stimulation for Borderline Personality Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Borderline Personality Disorder (BPD)', 'orgStudyIdInfo': {'id': '08 153 02'}, 'secondaryIdInfos': [{'id': 'AOL 2008'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rTMS', 'description': 'rTMS sessions', 'interventionNames': ['Procedure: repetitive Transcranial Stimulation Magnetic (rTMS)']}, {'type': 'SHAM_COMPARATOR', 'label': 'control', 'description': 'sham rTMS (control)', 'interventionNames': ['Procedure: sham rTMS']}], 'interventions': [{'name': 'repetitive Transcranial Stimulation Magnetic (rTMS)', 'type': 'PROCEDURE', 'description': "The motor threshold was determined in each subject once, before treatment. This was defined as the lowest stimulation intensity capable of inducing a visible movement at least five times out of 10 stimulations. The position of the right dorsolateral prefrontal cortex was defined as 5 cm anterior (in a parasagittal line) to the motor cortex. The stimulus intensity was 80% of the patient's motor threshold intensity. Treatments were given for 20 minutes per day over 10 working days.", 'armGroupLabels': ['rTMS']}, {'name': 'sham rTMS', 'type': 'PROCEDURE', 'description': 'sham rTMS', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'state': 'University Hospital Toulouse', 'country': 'France', 'facility': 'Lionel Cailhol', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Lionel Cailhol, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Toulouse - 31059 Toulouse - France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}