Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2026-01-01 @ 10:23 PM
Study NCT ID:
NCT01373866
Status:
COMPLETED
Last Update Posted:
2024-01-26
First Post:
2011-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal MRI-guided rTMS to Treat Refractory Hallucinations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006212', 'term': 'Hallucinations'}, {'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-25', 'studyFirstSubmitDate': '2011-05-13', 'studyFirstSubmitQcDate': '2011-06-14', 'lastUpdatePostDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity and Frequency of Hallucinations', 'timeFrame': 'Assessed at baseline (t0) and longitudinally after the 10 rTMS sessions during the following month (D+15, M+1, M+3, M+6, M+12)', 'description': 'Visual Analogue Scale (Severity)/ Visual Analogue Scale (Frequency rate)'}], 'secondaryOutcomes': [{'measure': 'Clinical State', 'timeFrame': 'Assessed at baseline (t0) and longitudinally after the 10 rTMS sessions during the following month (D+15, M+1, M+3, M+6, M+12)', 'description': 'Clinical Global Improvement \\[CGI\\]/ Positive \\& Negative Symptoms Scale \\[PANSS\\]/ Global Assessment of Functioning \\[GAF\\].\n\nFor the auditory modality: Add the Auditory Hallucinations rating Scale \\[AHRS\\] frequency scale and total score/ Add the computerized Binary Scale of Auditory Speech Hallucinations \\[cbSASH\\]'}, {'measure': 'MRI changes', 'timeFrame': 'Assessed at baseline (t0) and 1 month after the rTMS sessions (M+1)', 'description': 'structural MRI/ functional MRI/ Diffusion Tensor Imaging/ MR-spectroscopy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Repetitive Transcranial Magnetic Stimulation', 'Neuronavigation', 'Functional Magnetic Resonance Imaging', 'Diffusion Tensor Imaging'], 'conditions': ['Hallucinations', 'Schizophrenia', 'Perceptual Disorders']}, 'referencesModule': {'references': [{'pmid': '28660668', 'type': 'DERIVED', 'citation': 'Leroy A, Foucher JR, Pins D, Delmaire C, Thomas P, Roser MM, Lefebvre S, Amad A, Fovet T, Jaafari N, Jardri R. fMRI capture of auditory hallucinations: Validation of the two-steps method. Hum Brain Mapp. 2017 Oct;38(10):4966-4979. doi: 10.1002/hbm.23707. Epub 2017 Jun 28.'}]}, 'descriptionModule': {'briefSummary': '* The efficacy of neuro-navigated rTMS for patients with schizophrenia suffering from drug-resistant multisensory hallucinations will be tested by the implementation of a double-blind randomized controlled trial (RCT)\n* This study will use a combination of different MRI modalities (fMRI and DTI) to define with precision rTMS brain-targets in the case of multisensory hallucinations\n* The investigators anticipate that multimodal MRI-guided rTMS will allow a significant improvement in the efficacy of neuromodulation treatment of refractory hallucinations'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Right-handed Female/Male, \\[13-60 y.o.\\],\n* Schizophrenia (DSM-IV-TR diagnosis),\n* Drug-resistant hallucinations (Kinon \\& Kane criteria, 1993),\n* Unmodified antipsychotic dosage during the 30 days preceding rMTS,\n* No anticonvulsive medication,\n* No neurological disorder, no addictive behavior,\n* Matched for sex, age and PANSS scores,\n* Consent to participate to the study,\n\nExclusion Criteria:\n\n* Pregnancy\n* Contraindication to MRI scan\n* Contraindication to rTMS treatment\n* Claustrophobia\n* No social insurance'}, 'identificationModule': {'nctId': 'NCT01373866', 'acronym': 'MULTIMODHAL', 'briefTitle': 'Multimodal MRI-guided rTMS to Treat Refractory Hallucinations', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Multimodal MRI-guided Repetitive Transcranial Magnetic Stimulation to Treat Drug-resistant Hallucinations: a Randomized Control Trial', 'orgStudyIdInfo': {'id': '2009_17/0927'}, 'secondaryIdInfos': [{'id': '2009-A00842-55', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multimodal MRI-guided rTMS', 'interventionNames': ['Device: MagPro X100 repetitive Transcranial Magnetic Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional T3-P3 rTMS', 'interventionNames': ['Device: MagPro X100 repetitive Transcranial Magnetic Stimulation']}], 'interventions': [{'name': 'MagPro X100 repetitive Transcranial Magnetic Stimulation', 'type': 'DEVICE', 'description': 'Target defined using both fMRI during hallucinations occurence and tractography.\n\nParameters: 1 Hz/ 100% of the Motor Threshold/ 10 sessions (2/ day over 5 days)/ 1200 pulses/ session', 'armGroupLabels': ['Multimodal MRI-guided rTMS']}, {'name': 'MagPro X100 repetitive Transcranial Magnetic Stimulation', 'type': 'DEVICE', 'description': 'Target: T3-P3 (10-20 EEG international System). Parameters: 1 Hz/ 100% of the Motor Threshold/ 10 sessions (2/ day over 5 days)/ 1200 pulses/ session', 'armGroupLabels': ['Conventional T3-P3 rTMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'F-59037', 'city': 'Lille', 'country': 'France', 'facility': 'Lille University Hospital Centre', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '75005', 'city': 'Paris', 'country': 'France', 'facility': 'Saint-Anne Psychiatric Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Renaud Jardri, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lille University Medical Centre, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}