Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 6:38 PM
Study NCT ID:
NCT04354935
Status:
RECRUITING
Last Update Posted:
2023-02-27
First Post:
2020-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Resistant Depression by Repetitive Transcranial Magnetic Stimulation (rTMS) Multicentric Naturalistic Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicentric Naturalistic Study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-23', 'studyFirstSubmitDate': '2020-04-16', 'studyFirstSubmitQcDate': '2020-04-17', 'lastUpdatePostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measure the evolution of the HDRS-17 score', 'timeFrame': 'an average of 1 year', 'description': 'The evolution of the HDRS-17 score (Hamilton depression scale, 17 items) between the Baseline and the end of the initial 4 to 6 week treatment course'}], 'secondaryOutcomes': [{'measure': 'Rate of responding patients', 'timeFrame': 'an average of 1 year', 'description': 'Rate of responder patients (defined by a 50% decrease in HDRS score)'}, {'measure': 'Rate of patients in remission', 'timeFrame': 'an average of 1 year', 'description': 'defined by HDRS score\\<8'}, {'measure': 'Evolution of the quality of life score', 'timeFrame': 'an average of 1 year', 'description': 'EQ5D between Baseline and the end of the initial treatment between 4 and 6 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rTMS', 'TMS', 'depression'], 'conditions': ['To Evaluate the Effectiveness of Open rTMS']}, 'descriptionModule': {'briefSummary': 'Repetitive Transcranial Magnetic Stimulation (rTMS) for repetitive Transcranial Magnetic Stimulation) is a a recent technique to stimulate the brain in a way that non-invasive, for therapeutic purposes. The first trials of analgesic use of rTMS date back to about 15 years ago. years and clinical use has now entered the practice of some specialized centers. Used at a frequency less than or equal to 1 Hertz (Hz; a stimulation per second), it is called bass rTMS. frequency and results in inhibition of cortical excitability at the level of the stimulated area. Conversely, a stimulation with a frequency higher than 5 Hz, called high-frequency rTMS, will have an excitatory effect on the targeted neurons. In addition to its local effects at the stimulation site, rTMS can also have effects on distance on regions other than those directly targeted. The impact of this treatment would be the local modulation of the cerebral plasticity and also act on the anatomical connectivity and functional brain function in both healthy subjects and those who are patients with psychiatric disorders', 'detailedDescription': 'Main objective :\n\nTo show the effectiveness of rTMS carried out in open on the symptoms of depression resistant in common practice between the Baseline and the end of the initial treatment (between 1 and 6 weeks).\n\nSecondary Objectives\n\nEvaluate the tolerance of the rTMS carried out in open on the symptoms of depression resistant in common practice between the Baseline and the end of the initial cure (between 1 and 6 weeks)\n\nEvaluate the impact of this treatment on :\n\n* The response rate\n* The remission rate\n* Quality of life To assess the correlation between personality dimensions and depression.\n\nThe criteria main evaluation :\n\nThe evolution of the HDRS-17 score (Hamilton depression scale, 17 items) between the Baseline and the end of the initial treatment (1 to 6 weeks)\n\nThe evaluation criteria secondary :\n\n* Responder patient rate (defined as a 50% decrease in the rate of\n\n % of HDRS score)\n* Rate of patients in remission (defined by HDRS score\\<8)\n* Evolution of the EQ5D quality of life score between Baseline and end of the initial treatment (between 1 and 6 weeks)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presenting a depressive episode characterized as resistant according to the DSM 5 criteria\n* resistance is characterized by: non-response to at least two different antidepressants prescribed at effective doses for a duration greater than or equal to 6 weeks.\n* Patient who agrees to participate in the study and who has signed an informed consent.\n* Patient fluent in French\n* Affiliation to a social security scheme.\n* Women of childbearing age must be on contraception\n\nExclusion Criteria:\n\n* Presenting a contraindication to TMS: intrafemale foreign body cranial, unstable epilepsy, cochlear implant, pacemaker, pregnancy\n* Presence of a psychotic disorder\n* Presence of an unstable medical condition\n* Presence of schizophrenia or persistent delusional disorder\n* Persons under guardianship, curatorship and safeguarding of justice.\n* Pregnant women,\n* Woman of childbearing age without effective contraception\n* Breastfeeding woman'}, 'identificationModule': {'nctId': 'NCT04354935', 'acronym': 'DSNATUR', 'briefTitle': 'Treatment of Resistant Depression by Repetitive Transcranial Magnetic Stimulation (rTMS) Multicentric Naturalistic Study', 'organization': {'class': 'OTHER', 'fullName': 'Centre hospitalier de Ville-Evrard, France'}, 'officialTitle': 'Treatment of Resistant Depression by Repetitive Transcranial Magnetic Stimulation (rTMS) Multicentric Naturalistic Study', 'orgStudyIdInfo': {'id': '10477M-DSNATUR-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Method 1 ( iTBS)', 'description': 'target region: Dorsolateral Prefrontal left Fréquence : 50 Hz Intensity of the stimulation : 120% SM duration : 3 minutes Number of pulses : 600', 'interventionNames': ['Device: rTMS basic']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Method 2 (French touch)', 'description': 'target region : dorsolateral prefrontal cortex right Frequency:1HZ Intensity:120% SM duration : 8 Min 30 Sec Number of plulses : 360', 'interventionNames': ['Device: rTMS basic']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Method 3 (FDA)', 'description': 'target region: Dorsolateral Prefrontal left Fréquence : 10HZ Intensity of the stimulation : 120% SM duration : 37 minutes Number of pulses : 3000', 'interventionNames': ['Device: rTMS basic']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Method 4 (ITBS VIIT)', 'description': 'target region: Dorsolateral Prefrontal left Fréquence : 50HZ Intensity of the stimulation : 90% SM Duration : 9 minutes Number of pulses : 1800', 'interventionNames': ['Device: rTMS VIIT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Method 5 (SNTm)', 'description': 'Target region: Dorsolateral Prefrontal left Fréquence : 50HZ Intensity of the stimulation : 90% SM Duration : 9 minutes Number of pulses : 1800', 'interventionNames': ['Device: rTMS SAINT modified']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Method 6 (SNT)', 'description': 'Target region: Dorsolateral Prefrontal left Fréquence : 50HZ Intensity of the stimulation : 90% SM Duration : 9 minutes Number of pulses : 1800', 'interventionNames': ['Device: rTMS SAINT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Method 7 (DASH)', 'description': 'Target region: Dorsolateral Prefrontal left Fréquence : 10HZ Intensity of the stimulation : 120% SM Duration : 18.75 minutes Number of pulses : 3000', 'interventionNames': ['Device: rTMS basic']}], 'interventions': [{'name': 'rTMS basic', 'type': 'DEVICE', 'description': '1 session per day, for 4 or 6 weeks.', 'armGroupLabels': ['Method 1 ( iTBS)', 'Method 2 (French touch)', 'Method 3 (FDA)', 'Method 7 (DASH)']}, {'name': 'rTMS VIIT', 'type': 'DEVICE', 'description': '5 sessions per day, for 2 weeks.', 'armGroupLabels': ['Method 4 (ITBS VIIT)']}, {'name': 'rTMS SAINT modified', 'type': 'DEVICE', 'description': '8 sessions per day, for 1 week.', 'armGroupLabels': ['Method 5 (SNTm)']}, {'name': 'rTMS SAINT', 'type': 'DEVICE', 'description': '10 sessions per day, for 1 week.', 'armGroupLabels': ['Method 6 (SNT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93330', 'city': 'Neuilly-sur-Marne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Youcef BENCHERIF', 'role': 'CONTACT', 'email': 'bencherif.info@gmail.com', 'phone': '0782723674'}], 'facility': 'Youcef Bencherif', 'geoPoint': {'lat': 48.85373, 'lon': 2.54903}}, {'zip': '93330', 'city': 'Neuilly-sur-Marne', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'BENCHERIF, CRA', 'role': 'CONTACT', 'phone': '0143093232'}], 'facility': 'Unité de recherche clinique', 'geoPoint': {'lat': 48.85373, 'lon': 2.54903}}], 'centralContacts': [{'name': 'YOUCEF BENCHERIF', 'role': 'CONTACT', 'email': 'youcef.bencherif@gmail.com', 'phone': '0782723674'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre hospitalier de Ville-Evrard, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'psychiatrist', 'investigatorFullName': 'Noomane Bouaziz, MD', 'investigatorAffiliation': 'Centre hospitalier de Ville-Evrard, France'}}}}