Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-02-21 @ 10:11 PM
Study NCT ID:
NCT02652832
Status:
UNKNOWN
Last Update Posted:
2018-08-01
First Post:
2015-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Noninvasive Brain Stimulation Techniques on BDNF Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-31', 'studyFirstSubmitDate': '2015-10-19', 'studyFirstSubmitQcDate': '2016-01-08', 'lastUpdatePostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum BDNF levels', 'timeFrame': 'from baseline to one month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Depression', 'Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effects of non invasive brain stimulation - NIBS - techniques (Electroconvulsivotherapy - ECT, transcranial Direct Current Stimulation - tDCS, repetitive transcranial magnetic stimulation - rTMS) on serum Brain Derived Neurotrophic factor (BDNF) levels in patients with depression and schizophrenia. Four blood samples will be collected in each participants, one before the NIBS sessions, and 3 after the completion of NIBS protocols: one immediately after the end of the NIBS sessions, a second one week after and a last one month after. Two blood samples separated by one month will also be collected in a a group of healthy volunteers.', 'detailedDescription': 'The hypothesis is that NIBS will modulate BDNF levels and that the modification in serum BDNF levels will be correlated with clinical improvements in the sample of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* in the depression group: DSM IV criteria of MDD; HDRS17\\> 22; stage 2 of resistance; received rTMS or ECT\n* in the schizophrenia group DSM IV criteria of schizophrenia; pharmaco-resistance of symptoms (either negative symptoms or auditory verbal hallucination); received rTMS or tDCS\n* in the healthy volunteers group : to not have axis I of DSM IV diagnosis; no siblings with axis I DSM IV diagnosis\n\nExclusion Criteria:\n\n* less than 18 years old\n* pregnancy\n* received benzodiazepine\n\nIn the depression and schizophrenia group:\n\n* bipolar disorder\n* other axis I of DSM IV diagnosis (excluding for Tobacco use disorder)'}, 'identificationModule': {'nctId': 'NCT02652832', 'acronym': 'Plasti-Stim', 'briefTitle': 'Effects of Noninvasive Brain Stimulation Techniques on BDNF Levels', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital le Vinatier'}, 'officialTitle': 'Effects of Noninvasive Brain Stimulation Techniques on BDNF Levels', 'orgStudyIdInfo': {'id': 'CSR B04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Depression Electroconvulsive therapy', 'description': '40 patients with major depression receiving a mean of 12 sessions of Electroconvulsive therapy', 'interventionNames': ['Device: non invasive brain stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Depression active repetitive transcranial magnetic stimulation', 'description': '40 patients with major depression receiving a mean 4 weeks of 1 Hz repetitive transcranial magnetic stimulation applied over the right dorsolateral prefrontal cortex - DLPFC', 'interventionNames': ['Device: non invasive brain stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Depression sham repetitive transcranial magnetic stimulation', 'description': '40 patients with major depression receiving a mean 4 weeks of sham 1 Hz repetitive transcranial magnetic stimulation applied over the right dorsolateral prefrontal cortex - DLPFC', 'interventionNames': ['Device: non invasive brain stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Schizophrenia active transcranial magnetic stimulati', 'description': '40 patients with schizophrenia and predominant negative symptoms receiving 20 sessions of intermittent theta burst simulation (iTBS) applied over the left dorsolateral prefrontal cortex - DLPFC', 'interventionNames': ['Device: non invasive brain stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Schizophrenia sham transcranial magnetic stimulation', 'description': 'patients with schizophrenia and predominant negative symptoms receiving 20 sessions of sham intermittent theta burst simulation (iTBS) applied over the left dorsolateral prefrontal cortex - DLPFC', 'interventionNames': ['Device: non invasive brain stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Schizophrenia active transcranial Direct Current Stimulation', 'description': '40 patients with schizophrenia and auditory verbal hallucinations receiving 10 sessions of transcranial Direct current stimulation (tDCS) applied with the anode over the left dorsolateral prefrontal cortex - DLPFC- and the cathode over the left temporoparietal junction', 'interventionNames': ['Device: non invasive brain stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Schizophrenia sham transcranial Direct Current Stimulation', 'description': '40 patients with schizophrenia and auditory verbal hallucinations receiving 10 sessions of sham transcranial Direct current stimulation (tDCS) applied with the anode over the left dorsolateral prefrontal cortex - DLPFC- and the cathode over the left temporoparietal junction', 'interventionNames': ['Device: non invasive brain stimulation']}, {'type': 'NO_INTERVENTION', 'label': 'Healthy volunteers', 'description': '80 healthy volunteers receiving no stimulation'}], 'interventions': [{'name': 'non invasive brain stimulation', 'type': 'DEVICE', 'otherNames': ['rTMS', 'tDCS', 'ECT'], 'description': 'non invasive brain stimulation', 'armGroupLabels': ['Depression Electroconvulsive therapy', 'Depression active repetitive transcranial magnetic stimulation', 'Depression sham repetitive transcranial magnetic stimulation', 'Schizophrenia active transcranial Direct Current Stimulation', 'Schizophrenia active transcranial magnetic stimulati', 'Schizophrenia sham transcranial Direct Current Stimulation', 'Schizophrenia sham transcranial magnetic stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69677', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'emmanuel poulet, MD, PhD', 'role': 'CONTACT', 'phone': '33437915565'}, {'name': 'emmanuel poulet, md, phd', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'frederic haesebaert, md, phd', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hopital Le vinatier', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'centralContacts': [{'name': 'lydie sartelet', 'role': 'CONTACT', 'email': 'lydie.sartelet@ch-le-vinatier.fr', 'phone': '+33437915531'}], 'overallOfficials': [{'name': 'jerome brunelin, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CH le vinatier'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital le Vinatier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}