Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-28 @ 8:08 PM
Study NCT ID:
NCT02175251
Status:
COMPLETED
Last Update Posted:
2023-09-08
First Post:
2014-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low and High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Resistant Auditory Hallucination in Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-07', 'studyFirstSubmitDate': '2014-05-22', 'studyFirstSubmitQcDate': '2014-06-25', 'lastUpdatePostDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the efficiency of high frequency (20Hz) repetitive Transcranial Magnetic Stimulation (rTMS) to the left temporoparietal cortex compared to sham controlled condition rTMS in term on Auditory Hallucinations reduction.', 'timeFrame': '5 day', 'description': 'Auditory Hallucinations improvement at 5-day was evaluate with AHRS (Auditory Hallucination Rating Scale) score'}], 'secondaryOutcomes': [{'measure': 'To compare the efficiency of low frequency (1Hz) to sham-controlled condition repetitive Transcranial Magnetic Stimulation (rTMS) in term of Auditory Hallucination reduction.', 'timeFrame': '5 days', 'description': 'Auditory Hallucinations improvement evaluated with Auditory Hallucination Rating Scale (AHRS)'}, {'measure': 'To compare the efficiency of high frequency to low frequency (1Hz) in term of Auditory Hallucination reduction.', 'timeFrame': '5 days', 'description': 'Auditory Hallucinations improvement evaluated with Auditory Hallucination Rating Scale (AHRS)'}, {'measure': 'To compare the maintenance of therapeutic effect for one month of high frequency to low frequency (1Hz) in term of Auditory Hallucination reduction.', 'timeFrame': '1 month', 'description': 'Auditory Hallucinations improvement evaluated with Auditory Hallucination Rating Scale (AHRS)'}, {'measure': 'To evaluate the maintenance of therapeutic effect of high frequency compared to sham controlled condition for 15 days 1 month, 2 months and 3 months', 'timeFrame': '15 days 1 month, 2 months and 3 months'}, {'measure': 'To compare the side effects of each of the active treatment', 'timeFrame': 'at Inclusion and 5 day', 'description': 'Tolerance assessed with the UDVALG of KLINISKE UNDERSOGELSER scale (UKU )'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['rTMS', 'Schizophrenia', 'high frequency rTMS', 'low frequency rTMS', 'AHRS', 'SAPS SANS PANSS', 'GAF', 'UKU'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'Auditory Hallucinations (AH) are experienced by 50 to 70% of subjects with schizophrenia. Almost a quarter of patients are medication resistant to such symptoms. The application of rTMS at low frequency in the left temporoparietal cortex reduces AH. A pilot study reported successful treatment of AH with high frequency rTMS. rTMS (20Hz) should be a shorter and an easier treatment for out-patients with schizophrenia compared to low stimulation treatment.', 'detailedDescription': '90 schizophrenia patients Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM IV-TR) criteria with persistent Auditory Hallucinations (AH) resistant to antipsychotic treatments will be recruited. A double blind sham-controlled randomized parallel study comparing three groups treated 10 session in 5 days with high frequency (20 Hz), low frequency (1Hz) and sham-controlled condition rTMS. They will be followed 3 month and evaluated using Auditive Hallucination Rating Scale (AHRS), Scale for the Assessment of Positive Symptoms Scores (SAPS), Scale for the Assessment of Negative Symptoms Scores (SANS) and Positive And Negative Symptom Scale (PANSS) global score and Global Assessment of Functioning (GAF) score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with schizophrenia DSM IV-TR criteria and persistent AH resistant to antipsychotic treatments.\n\nExclusion Criteria:\n\n* Left handed patients lateralizes\n* rTMS contraindications'}, 'identificationModule': {'nctId': 'NCT02175251', 'acronym': 'rTMS', 'briefTitle': 'Low and High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Resistant Auditory Hallucination in Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Low and High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Resistant Auditory Hallucination in Schizophrenia: a Double Blind Sham-controlled Randomised Study', 'orgStudyIdInfo': {'id': 'P120909'}, 'secondaryIdInfos': [{'id': 'IDRCB 2013-A00872-43', 'type': 'OTHER', 'domain': 'FRENCH AUTHORITY'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'low frequency (1Hz)', 'description': 'low frequency', 'interventionNames': ['Procedure: low frequency (1Hz)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Comparator', 'description': 'Sham Comparator', 'interventionNames': ['Procedure: Sham Comparator']}, {'type': 'EXPERIMENTAL', 'label': 'high frequency (20Hz)', 'description': 'high frequency', 'interventionNames': ['Procedure: high frequency (20Hz)']}], 'interventions': [{'name': 'high frequency (20Hz)', 'type': 'PROCEDURE', 'description': '10 session in 5 days with high frequency (20 Hz)', 'armGroupLabels': ['high frequency (20Hz)']}, {'name': 'low frequency (1Hz)', 'type': 'PROCEDURE', 'description': '10 session in 5 days with low frequency (1Hz)', 'armGroupLabels': ['low frequency (1Hz)']}, {'name': 'Sham Comparator', 'type': 'PROCEDURE', 'description': '10 session in 5 days with sham-controlled', 'armGroupLabels': ['Sham Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92700', 'city': 'Colombes', 'country': 'France', 'facility': 'Department of Psychiatry, Louis Mourier Hospital', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}], 'overallOfficials': [{'name': 'Caroline DUBERTRET, PU-PH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Psychiatry, Louis MOURIER Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}