Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT04352569
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2015-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of tDCS in the Treatment of Resistant Auditory Hallucinations in Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D006212', 'term': 'Hallucinations'}, {'id': 'D000090663', 'term': 'Schizophrenia, Treatment-Resistant'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'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'}]}, '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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-03-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-15', 'studyFirstSubmitDate': '2015-10-27', 'studyFirstSubmitQcDate': '2020-04-17', 'lastUpdatePostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'auditory hallucinations rating scale (AHRS)', 'timeFrame': 'At baseline', 'description': 'AHRS is a scale frequently used to assess auditory hallucinations in schizophrenia studies (Hoffman et al. 2005).'}, {'measure': 'auditory hallucinations rating scale (AHRS)', 'timeFrame': '15 days after', 'description': 'AHRS is a scale frequently used to assess auditory hallucinations in schizophrenia studies (Hoffman et al. 2005).'}], 'secondaryOutcomes': [{'measure': 'PANSS,', 'timeFrame': 'At baseline', 'description': 'Positive and negative symptom scale (PANSS, Kay et al. 1988)'}, {'measure': 'PANSS,', 'timeFrame': '15 days after', 'description': 'Positive and negative symptom scale (PANSS, Kay et al. 1988)'}, {'measure': 'CGI', 'timeFrame': 'At baseline', 'description': 'clinical global impression (Kadouri et al. 2007)'}, {'measure': 'CGI', 'timeFrame': '15 days after', 'description': 'clinical global impression (Kadouri et al. 2007)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Hallucinations', 'Refractory Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The regions which are assumed to underlie the pathophysiology of schizophrenia, namely hypoactivity at the prefrontal level and pathological hyperactivity of the associative regions of the language located in the left temporoparietal region.\n\nTo assess the efficacy of tDCS on auditory hallucinations, the investigators performs an randomized double blind versus placebo trial. In each arms patients will receive two tDCS sessions a day during two weeks.', 'detailedDescription': "Hearing hallucinations are one of the major symptoms of schizophrenia. In 30% of patients they are resistant to common psychotropic treatments. tDCS (Transcranial Direct Current Stimulation) is a technical of brain stimulation, non-invasive, painless that modulates brain activity by the transcranial administration of a low-intensity electric current, via two electrodes (an anode and a cathode). Several scientifics studies have reported a beneficial effect of tDCS in the treatment of pain, depression and especially hearing hallucinations in schizophrenia.\n\nThe main study purpose is to evaluate the effectiveness of tDCS on resistant auditory hallucinations in patients with schizophrenia.\n\nThen, to evaluate the effectiveness of tDCS on global schizophrenic symptomatology and to assess the impact of tDCS on patients' quality of life.\n\nAlso the study, evaluate the impact of tDCS on cortical excitability. We measure the change in serum BDNF (Brain Derived Neutrophic Factor) before and after tDCS stimulation. Indeed, to evaluate the impact of tDCS on neurocognitive functions.\n\nPatients will receive either active tDCS or placebo tDCS randomly. All patients will have two tDCS/day sessions, one hour apart, for 2 working weeks. The stimulation parameters will be consistent with the literature data, namely: Intensity = 2mA; duration of sessions = 20 minutes; total number of sessions = 20 (2 daily sessions for two working weeks)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Schizophrenia according to DSM-V.\n* Refractory auditory hallucinations(despite two antipsychotics trials).\n* Right-handed patients.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Presence of other psychiatric disorders than schizophrenia (except addiction to tobacco or caffeine ).\n* History of severe head trauma or coma.\n* History of epilepsy or neurological disorder or a general medical condition.\n* Presence of intracranial metallic objects or pacemaker.\n* Hospitalized patients without consent.\n* pregnant women .'}, 'identificationModule': {'nctId': 'NCT04352569', 'acronym': 'TDCSHALLU', 'briefTitle': 'Efficacy of tDCS in the Treatment of Resistant Auditory Hallucinations in Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Centre hospitalier de Ville-Evrard, France'}, 'officialTitle': 'Efficacy of tDCS in the Treatment of Resistant Auditory Hallucinations in Schizophrenia: A Double Blind, Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'DMDPT-TCH/MM/2015-A00842-47'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'transcranial direct current stimulation', 'description': 'The transcranial direct current stimulation (tDCS) with two elecrodes placed over the scalp: the anode over the LTP, le cathode over L DLPFG.', 'interventionNames': ['Device: transcranial direct current stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'transcranial direct current stimulation sham', 'description': 'tDCS device allows sham stimulation. This technic give the same impression that active stimulation and allows optimum placebo stimulation.', 'interventionNames': ['Device: transcranial direct current stimulation']}], 'interventions': [{'name': 'transcranial direct current stimulation', 'type': 'DEVICE', 'otherNames': ['tDCS'], 'description': 'transcranial direct current stimulation (tDCS) is a non invasive brain stimulation technic', 'armGroupLabels': ['transcranial direct current stimulation', 'transcranial direct current stimulation sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93332', 'city': 'Neuilly-sur-Marne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Rusheenthira THAVASEELAN, Msc', 'role': 'CONTACT', 'email': 'r.thavaseelan@epsve.fr', 'phone': '0143093232'}], 'facility': "unité de recherche clinique de l'E.P.S de Ville Evrard", 'geoPoint': {'lat': 48.85373, 'lon': 2.54903}}], 'centralContacts': [{'name': 'Rusheenthira THAVASEELAN, Msc', 'role': 'CONTACT', 'email': 'r.thavaseelan@epsve.fr', 'phone': '0143093232'}, {'name': 'NOOMANE BOUAZIZ, MD', 'role': 'CONTACT', 'email': 'urcve1@gmail.com', 'phone': '0143093232'}], 'overallOfficials': [{'name': 'NOOMANE BOUAZIZ, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Unité de Recherche Clinique de l'EPS de Ville Evard"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre hospitalier de Ville-Evrard, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Noomane Bouaziz, MD', 'investigatorAffiliation': 'Centre hospitalier de Ville-Evrard, France'}}}}