Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:36 PM
Study NCT ID:
NCT07452835
Status:
COMPLETED
Last Update Posted:
2026-03-06
First Post:
2026-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcranial Direct Current Stimulation (tDCS) in Different Psychiatric Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}, {'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-12-01', 'size': 931396, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2026-03-01T07:47', 'hasProtocol': True}, {'date': '2023-12-01', 'size': 790606, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2026-03-01T07:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A comparative cross-sectional study including five diagnostic groups:\n\nMajor Depressive Disorder (MDD), Schizophrenia, Obsessive-Compulsive Disorder (OCD), Generalized Anxiety Disorder (GAD), and Insomnia'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-03-01', 'studyFirstSubmitQcDate': '2026-03-01', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Montgomery-Åsberg Depression Rating Scale', 'timeFrame': 'The assessment period for each participant was 24 weeks from the start of their participation in the study.', 'description': 'Depression severity was assessed using the Montgomery-Åsberg Depression Rating Scale. The total scores on this scale range from a minimum of 0 to a maximum of 60, with higher scores indicating a greater severity of depressive symptoms (a worse outcome)'}, {'measure': 'Positive and Negative Syndrome Scale', 'timeFrame': 'The assessment period for each participant was 24 weeks from the start of their participation in the study.', 'description': 'Symptom severity was evaluated using the Positive and Negative Syndrome Scale. Total scores on this scale range from a minimum of 30 to a maximum of 210, with higher scores indicating a greater severity of symptoms (a worse outcome).'}], 'secondaryOutcomes': [{'measure': 'Yale-Brown Obsessive Compulsive Scale', 'timeFrame': 'The assessment period for each participant was 24 weeks from the start of their participation in the study.', 'description': 'The severity of obsessive-compulsive symptoms was measured using the Yale-Brown Obsessive Compulsive Scale. Total scores on this scale range from a minimum of 0 to a maximum of 40, with higher scores indicating more severe symptoms (a worse outcome).'}, {'measure': 'Generalized Anxiety Disorder-7', 'timeFrame': 'The assessment period for each participant was 24 weeks from the start of their participation in the study.', 'description': 'Anxiety severity was measured using the Generalized Anxiety Disorder-7 scale. Total scores on this scale range from a minimum of 0 to a maximum of 21, with higher scores indicating more severe anxiety symptoms (a worse outcome).'}, {'measure': 'Insomnia Severity Index - 7 items', 'timeFrame': 'The assessment period for each participant was 24 weeks from the start of their participation in the study.', 'description': 'The severity of insomnia was assessed using the Insomnia Severity Index. Total scores on this scale range from a minimum of 0 to a maximum of 28, with higher scores indicating more severe insomnia symptoms (a worse outcome).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transcranial direct current stimulation', 'neuromodulation', 'psychiatric disorders', 'major depressive disorder', 'schizophrenia', 'obsessive-compulsive disorder', 'anxiety disorders', 'insomnia'], 'conditions': ['Major Depressive Disorder (MDD)', 'SCHIZOPHRENIA 1 (Disorder)', 'Obsessive-Compulsive Disorder', 'Generalized Anxiety Disorder', 'Insomnia']}, 'referencesModule': {'references': [{'pmid': '39473161', 'type': 'BACKGROUND', 'citation': 'Warthen KG, Walker NC, Wicklund BD, Gonzalez MM, Ramirez N, Gee SC, Al-Dasouqi H, Madore MR. Neuromodulation of the Cerebellum for Motor Applications: A Systematic Review. J Integr Neurosci. 2024 Oct 25;23(10):195. doi: 10.31083/j.jin2310195.'}, {'pmid': '28229395', 'type': 'BACKGROUND', 'citation': 'Hameed MQ, Dhamne SC, Gersner R, Kaye HL, Oberman LM, Pascual-Leone A, Rotenberg A. Transcranial Magnetic and Direct Current Stimulation in Children. Curr Neurol Neurosci Rep. 2017 Feb;17(2):11. doi: 10.1007/s11910-017-0719-0.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the efficacy and safety of transcranial direct current stimulation (tDCS) in reducing core symptoms of different psychiatric disorders using validated clinical scales.\n\n* To assess response and remission rates.\n* To evaluate the durability of treatment effects over follow-up.\n* To examine effects on cognition, daily functioning, and quality of life.\n* To monitor tolerability and adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 16 and 65 years\n* Fulfillment of DSM-5 diagnostic criteria for one of the target disorders\n* Stable pharmacological treatment for at least four weeks prior to enrollment (if applicable)\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* History of epilepsy or seizures\n* Presence of intracranial metallic implants or implanted electronic devices\n* Severe neurological disorders (e.g., brain tumors)\n* Pregnancy\n* Active substance use disorder\n* Severe cognitive impairment or comorbid psychiatric disorders interfering with assessment'}, 'identificationModule': {'nctId': 'NCT07452835', 'acronym': 'Transcranial', 'briefTitle': 'Transcranial Direct Current Stimulation (tDCS) in Different Psychiatric Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Menoufia University'}, 'officialTitle': 'Transcranial Direct Current Stimulation (tDCS) in Different Psychiatric Disorders', 'orgStudyIdInfo': {'id': '11/2025 com7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A comparative cross-sectional study: Major Depressive Disorder', 'description': '* Left DLPFC (F3) Anode: F3, Cathode: right supraorbital\n* 2 mA 20-30 min\n* 10 -20 daily )', 'interventionNames': ['Device: tDCS Parameters']}, {'type': 'EXPERIMENTAL', 'label': 'A comparative cross-sectional study: Schizophrenia', 'description': '* Left TPJ (P3) + Left DLPFC (F3)\n* Anode: P3, Cathode: F3 (for hallucinations)\n* 2 mA 20 min\n* 10-15', 'interventionNames': ['Device: tDCS Parameters']}, {'type': 'EXPERIMENTAL', 'label': 'A comparative cross-sectional study: Obsessive-Compulsive Disorder', 'description': '* SMA (Cz) or OFC (Fp1/Fp2)\n* Anode: Cz/Fp1, Cathode: contralateral shoulder\n* 2 mA 20 min\n* 10-20', 'interventionNames': ['Device: tDCS Parameters']}, {'type': 'EXPERIMENTAL', 'label': 'A comparative cross-sectional study ; Generalized Anxiety Disorder', 'description': '* Right DLPFC (F4) or vmPFC\n* Anode: F4, Cathode: left DLPFC (F3)\n* 2 mA -Session duration: 20-30 minutes per session.\n* 10', 'interventionNames': ['Device: tDCS Parameters']}, {'type': 'EXPERIMENTAL', 'label': 'comparative cross-sectional study; Insomnia', 'description': '* Left DLPFC (F3) or Parietal (Pz)\n* Anode: F3/Pz, Cathode: contralateral supraorbital\n* 2 mA -Session duration: 20-30 minutes per session.\n* 10 -12', 'interventionNames': ['Device: tDCS Parameters']}], 'interventions': [{'name': 'tDCS Parameters', 'type': 'DEVICE', 'description': 'Preparation:\n\n* Clean scalp with alcohol to reduce impedance.\n* Apply conductive gel and position electrodes using the 10-20 EEG system.\n* Use rubber electrodes (5×7 cm) for anodal/cathodal placement.\n\nStimulation:\n\nRamp-up current over 30 sec to avoid discomfort. Monitor for adverse effects (tingling, itching, headache ).\n\nPost-Stimulation Assessment:\n\n* Evaluate symptom changes using standardized scales (e.g., HAM-D for depression, Y-BOCS for OCD).\n* Repeat sessions 3-5 times per week.. Safety and Monitoring\n\nAdverse Effects:\n\nMild skin irritation, headache (rarely seizures-screen high-risk patients(.\n\nContraindications:\n\nMetallic implants, scalp lesions, epilepsy history. Conclusion tDCS is a promising neuromodulatory tool for psychiatric disorders, with varying protocols based on disorder-specific neural targets.', 'armGroupLabels': ['A comparative cross-sectional study ; Generalized Anxiety Disorder', 'A comparative cross-sectional study: Major Depressive Disorder', 'A comparative cross-sectional study: Obsessive-Compulsive Disorder', 'A comparative cross-sectional study: Schizophrenia', 'comparative cross-sectional study; Insomnia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32511', 'city': 'Cairo', 'state': 'Menofia', 'country': 'Egypt', 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mohamed Elbahy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'faculty of medicine'}, {'name': 'Mahmoud Abo Salem', 'role': 'STUDY_DIRECTOR', 'affiliation': 'faculty of medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'present', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after de-identification, will be shared with researchers who provide a methodologically sound proposal. The data will be available upon reasonable request to the principal investigator starting 6 months after publication. Requestors will need to sign a data access agreement before data is securely transferred'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menoufia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fellow Professor', 'investigatorFullName': 'SSalah el-bahy', 'investigatorAffiliation': 'Menoufia University'}}}}