Transcranial Direct Current Stimulation (tDCS) in Different Psychiatric Disorders (Transcranial)

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.

• To assess response and remission rates.
• To evaluate the durability of treatment effects over follow-up.
• To examine effects on cognition, daily functioning, and quality of life.
• To monitor tolerability and adverse events.

Study Overview

• Status: Completed
• Conditions: Obsessive-Compulsive Disorder; Insomnia; Generalized Anxiety Disorder; Major Depressive Disorder (MDD); SCHIZOPHRENIA 1 (Disorder)
• Intervention / Treatment: Device: tDCS Parameters

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Menofia
    • Cairo, Menofia, Egypt, 32511
      • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 16 and 65 years
• Fulfillment of DSM-5 diagnostic criteria for one of the target disorders
• Stable pharmacological treatment for at least four weeks prior to enrollment (if applicable)
• Ability to provide informed consent

Exclusion Criteria:

• History of epilepsy or seizures
• Presence of intracranial metallic implants or implanted electronic devices
• Severe neurological disorders (e.g., brain tumors)
• Pregnancy
• Active substance use disorder
• Severe cognitive impairment or comorbid psychiatric disorders interfering with assessment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A comparative cross-sectional study: Major Depressive Disorder; Left DLPFC (F3) Anode: F3, Cathode: right supraorbital; 2 mA 20-30 min; 10 -20 daily )	Device: tDCS Parameters; Preparation: Clean scalp with alcohol to reduce impedance.; Apply conductive gel and position electrodes using the 10-20 EEG system.; Use rubber electrodes (5×7 cm) for anodal/cathodal placement. Stimulation: Ramp-up current over 30 sec to avoid discomfort. Monitor for adverse effects (tingling, itching, headache ). Post-Stimulation Assessment: Evaluate symptom changes using standardized scales (e.g., HAM-D for depression, Y-BOCS for OCD).; Repeat sessions 3-5 times per week.. Safety and Monitoring Adverse Effects: Mild skin irritation, headache (rarely seizures-screen high-risk patients(. Contraindications: Metallic implants, scalp lesions, epilepsy history. Conclusion tDCS is a promising neuromodulatory tool for psychiatric disorders, with varying protocols based on disorder-specific neural targets.
Experimental: A comparative cross-sectional study: Schizophrenia; Left TPJ (P3) + Left DLPFC (F3); Anode: P3, Cathode: F3 (for hallucinations); 2 mA 20 min; 10-15	Device: tDCS Parameters; Preparation: Clean scalp with alcohol to reduce impedance.; Apply conductive gel and position electrodes using the 10-20 EEG system.; Use rubber electrodes (5×7 cm) for anodal/cathodal placement. Stimulation: Ramp-up current over 30 sec to avoid discomfort. Monitor for adverse effects (tingling, itching, headache ). Post-Stimulation Assessment: Evaluate symptom changes using standardized scales (e.g., HAM-D for depression, Y-BOCS for OCD).; Repeat sessions 3-5 times per week.. Safety and Monitoring Adverse Effects: Mild skin irritation, headache (rarely seizures-screen high-risk patients(. Contraindications: Metallic implants, scalp lesions, epilepsy history. Conclusion tDCS is a promising neuromodulatory tool for psychiatric disorders, with varying protocols based on disorder-specific neural targets.
Experimental: A comparative cross-sectional study: Obsessive-Compulsive Disorder; SMA (Cz) or OFC (Fp1/Fp2); Anode: Cz/Fp1, Cathode: contralateral shoulder; 2 mA 20 min; 10-20	Device: tDCS Parameters; Preparation: Clean scalp with alcohol to reduce impedance.; Apply conductive gel and position electrodes using the 10-20 EEG system.; Use rubber electrodes (5×7 cm) for anodal/cathodal placement. Stimulation: Ramp-up current over 30 sec to avoid discomfort. Monitor for adverse effects (tingling, itching, headache ). Post-Stimulation Assessment: Evaluate symptom changes using standardized scales (e.g., HAM-D for depression, Y-BOCS for OCD).; Repeat sessions 3-5 times per week.. Safety and Monitoring Adverse Effects: Mild skin irritation, headache (rarely seizures-screen high-risk patients(. Contraindications: Metallic implants, scalp lesions, epilepsy history. Conclusion tDCS is a promising neuromodulatory tool for psychiatric disorders, with varying protocols based on disorder-specific neural targets.
Experimental: A comparative cross-sectional study ; Generalized Anxiety Disorder; Right DLPFC (F4) or vmPFC; Anode: F4, Cathode: left DLPFC (F3); 2 mA -Session duration: 20-30 minutes per session.; 10	Device: tDCS Parameters; Preparation: Clean scalp with alcohol to reduce impedance.; Apply conductive gel and position electrodes using the 10-20 EEG system.; Use rubber electrodes (5×7 cm) for anodal/cathodal placement. Stimulation: Ramp-up current over 30 sec to avoid discomfort. Monitor for adverse effects (tingling, itching, headache ). Post-Stimulation Assessment: Evaluate symptom changes using standardized scales (e.g., HAM-D for depression, Y-BOCS for OCD).; Repeat sessions 3-5 times per week.. Safety and Monitoring Adverse Effects: Mild skin irritation, headache (rarely seizures-screen high-risk patients(. Contraindications: Metallic implants, scalp lesions, epilepsy history. Conclusion tDCS is a promising neuromodulatory tool for psychiatric disorders, with varying protocols based on disorder-specific neural targets.
Experimental: comparative cross-sectional study; Insomnia; Left DLPFC (F3) or Parietal (Pz); Anode: F3/Pz, Cathode: contralateral supraorbital; 2 mA -Session duration: 20-30 minutes per session.; 10 -12	Device: tDCS Parameters; Preparation: Clean scalp with alcohol to reduce impedance.; Apply conductive gel and position electrodes using the 10-20 EEG system.; Use rubber electrodes (5×7 cm) for anodal/cathodal placement. Stimulation: Ramp-up current over 30 sec to avoid discomfort. Monitor for adverse effects (tingling, itching, headache ). Post-Stimulation Assessment: Evaluate symptom changes using standardized scales (e.g., HAM-D for depression, Y-BOCS for OCD).; Repeat sessions 3-5 times per week.. Safety and Monitoring Adverse Effects: Mild skin irritation, headache (rarely seizures-screen high-risk patients(. Contraindications: Metallic implants, scalp lesions, epilepsy history. Conclusion tDCS is a promising neuromodulatory tool for psychiatric disorders, with varying protocols based on disorder-specific neural targets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery-Åsberg Depression Rating Scale	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)	The assessment period for each participant was 24 weeks from the start of their participation in the study.
Positive and Negative Syndrome Scale	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).	The assessment period for each participant was 24 weeks from the start of their participation in the study.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Yale-Brown Obsessive Compulsive Scale	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).	The assessment period for each participant was 24 weeks from the start of their participation in the study.
Generalized Anxiety Disorder-7	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).	The assessment period for each participant was 24 weeks from the start of their participation in the study.
Insomnia Severity Index - 7 items	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).	The assessment period for each participant was 24 weeks from the start of their participation in the study.

Collaborators and Investigators

• Sponsor: Menoufia University
• Investigators: Principal Investigator: Mohamed Elbahy, Faculty of medicine; Study Director: Mahmoud Abo Salem, Faculty of medicine

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: March 1, 2026
• First Submitted That Met QC Criteria: March 1, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: obsessive-compulsive disorder; schizophrenia; insomnia; major depressive disorder; neuromodulation; Transcranial direct current stimulation; anxiety disorders; psychiatric disorders
• Additional Relevant MeSH Terms: Nervous System Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Sleep Wake Disorders; Mood Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Depressive Disorder; Schizophrenia; Anxiety Disorders; Mental Disorders; Depressive Disorder, Major; Sleep Initiation and Maintenance Disorders; Obsessive-Compulsive Disorder; Generalized Anxiety Disorder
• Other Study ID Numbers: 11/2025 com7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan 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
• IPD Sharing Time Frame: present
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No