Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-27 @ 12:16 AM
Study NCT ID:
NCT02559466
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2015-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Deep Transcranial Magnetic Stimulation (TMS) for Treatment-resistant Depression and Neuroanatomical Correlates: a Clinical Study Coupled With Positon Emission Tomography (PET)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-23', 'studyFirstSubmitDate': '2015-09-23', 'studyFirstSubmitQcDate': '2015-09-23', 'lastUpdatePostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The depression score in Montgomery-Åsberg Depression Rating Scale (MADRS).', 'timeFrame': '24 month', 'description': 'performed before and after TMS'}], 'secondaryOutcomes': [{'measure': 'Short self-completion questionnaire on symptoms of depression', 'timeFrame': '24 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pharmaco-resistant depressed patients'], 'conditions': ['Pharmacoresistant Depression']}, 'descriptionModule': {'briefSummary': 'Repetitive transcranial magnetic stimulation (TMS) is an emergent non-invasive treatment for treatment resistant depression (TRD). The exact neuro-functional mechanisms related to TMS efficiency remains however unknown; besides local effect on the target, TMS may induce interaction changes between remote cerebral regions. On the other hand, few studies have been performed in comparison to sham placebo stimulation. The investigators recently showed that non-responder depressive patients to TMS exhibited deeper and wider brain functional abnormalities hardly reachable by standard coils. The H1-Coil is a novel TMS (H-TMS) device capable of inducing a magnetic field with a deeper and wider distribution than standard coils.\n\nThe investigators design here a randomized controlled study in which the investigators will compare the clinical effects of H-coil TMS and standard TMS in patients with TRD, and their functional neuroanatomical correlates and changes in connectivity by Positron Emission Tomography (PET). The general objective is to better understand the mechanisms related to TMS efficiency in pharmacoresistant depression, in order to propose the best therapeutic approach for the patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who met the diagnosis of major depressive episode (MDE)\n* Patient right-handed\n* Men and women aged over 18 years with major depressive episode IV (DSM-IV criteria), isolated or recurrent.\n* Scores on the scale MADRS\\> 20\n* Resistance Criterion defined as the failure of two antidepressants effective dose for a minimum of six weeks.\n* Drug Therapy stable for at least 2 weeks\n\nExclusion Criteria:\n\n* Bipolar disorder type I or type II\n* Depression With Psychotic Features\n* Diagnosis according comorbid Axis I (DSM IV) with schizophrenia, alcohol abuse and / or toxic substances.\n* Inpatient under stress or under legal protection measure (guardianship, curatorship)\n* Counter to the practice of Transcranial Magnetic Stimulation : a personal history of seizure, history of neurological or neurosurgical pathologies, metallic prosthetic material or foreign objects (pacemakers, prosthetic eye equipment, etc.).\n* Pregnant or breastfeeding ongoing.\n* Somatic disorder may affect cognitive abilities and brain structures\n* Known allergy to any component of Fludeoxyglucose'}, 'identificationModule': {'nctId': 'NCT02559466', 'briefTitle': 'Efficacy of Deep Transcranial Magnetic Stimulation (TMS) for Treatment-resistant Depression and Neuroanatomical Correlates: a Clinical Study Coupled With Positon Emission Tomography (PET)', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Efficacy of Deep Transcranial Magnetic Stimulation (TMS) for Treatment-resistant Depression and Neuroanatomical Correlates: a Randomized Clinical Study Coupled With Positon Emission Tomography (PET)', 'orgStudyIdInfo': {'id': '2015-08'}, 'secondaryIdInfos': [{'id': 'RCAPHM15_0084', 'type': 'OTHER', 'domain': 'APHM'}, {'id': '2015-A00345-44', 'type': 'REGISTRY', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients stimulated with a H-TMS (deep)', 'description': '20 sessions navigated with Deep Transcranial Magnetic Stimulation', 'interventionNames': ['Device: Transcranial Magnetic Stimulation (TMS - ) - MagPro®', 'Device: Positon Emission Tomography (PET) - Discovery 710®']}, {'type': 'OTHER', 'label': 'Patients stimulated with a conventional TMS', 'description': '20 sessions navigated with Conventional Transcranial Magnetic Stimulation', 'interventionNames': ['Device: Transcranial Magnetic Stimulation (TMS - ) - MagPro®', 'Device: Positon Emission Tomography (PET) - Discovery 710®']}], 'interventions': [{'name': 'Transcranial Magnetic Stimulation (TMS - ) - MagPro®', 'type': 'DEVICE', 'description': 'Class IIa', 'armGroupLabels': ['Patients stimulated with a H-TMS (deep)', 'Patients stimulated with a conventional TMS']}, {'name': 'Positon Emission Tomography (PET) - Discovery 710®', 'type': 'DEVICE', 'description': 'Class IB', 'armGroupLabels': ['Patients stimulated with a H-TMS (deep)', 'Patients stimulated with a conventional TMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13354', 'city': 'Marseille', 'country': 'France', 'facility': 'Assistance Publique Hôpitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'Urielle DESALBRES, Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique Hôpitaux de Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}