Transcranial Direct Current Stimulation (tDCS) in Different Psychiatric Disorders

NCT07452835 | Completed

• 1 other identifier: 11/2025 com7
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder (MDD); SCHIZOPHRENIA 1 (Disorder); Obsessive-Compulsive Disorder; Generalized Anxiety Disorder; Insomnia

Keywords

Transcranial direct current stimulation; neuromodulation; psychiatric disorders; major depressive disorder; schizophrenia; obsessive-compulsive disorder; anxiety disorders; insomnia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Yale-Brown Obsessive Compulsive Scale

  The assessment period for each participant was 24 weeks from the start of their participation in the study.

• Generalized Anxiety Disorder-7

  The assessment period for each participant was 24 weeks from the start of their participation in the study.

• Insomnia Severity Index - 7 items

  The assessment period for each participant was 24 weeks from the start of their participation in the study.

Study Arms (5)

A comparative cross-sectional study: Major Depressive Disorder

EXPERIMENTAL

* Left DLPFC (F3) Anode: F3, Cathode: right supraorbital * 2 mA 20-30 min * 10 -20 daily )

Device: tDCS Parameters

A comparative cross-sectional study: Schizophrenia

EXPERIMENTAL

* Left TPJ (P3) + Left DLPFC (F3) * Anode: P3, Cathode: F3 (for hallucinations) * 2 mA 20 min * 10-15

Device: tDCS Parameters

A comparative cross-sectional study: Obsessive-Compulsive Disorder

EXPERIMENTAL

* SMA (Cz) or OFC (Fp1/Fp2) * Anode: Cz/Fp1, Cathode: contralateral shoulder * 2 mA 20 min * 10-20

Device: tDCS Parameters

A comparative cross-sectional study ; Generalized Anxiety Disorder

EXPERIMENTAL

* Right DLPFC (F4) or vmPFC * Anode: F4, Cathode: left DLPFC (F3) * 2 mA -Session duration: 20-30 minutes per session. * 10

Device: tDCS Parameters

comparative cross-sectional study; Insomnia

EXPERIMENTAL

* 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

Interventions

tDCS Parameters DEVICE

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.

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

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Faculty of Medicine

Cairo, Menofia, 32511, Egypt

Location

Related Publications (2)

• 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: 39473161 BACKGROUND

• 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.

  PMID: 28229395 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major; Obsessive-Compulsive Disorder; Generalized Anxiety Disorder; Sleep Initiation and Maintenance Disorders; Mental Disorders; Schizophrenia; Anxiety Disorders

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• Mohamed Elbahy

  faculty of medicine

  PRINCIPAL INVESTIGATOR

• Mahmoud Abo Salem

  faculty of medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow Professor

Model Details: A comparative cross-sectional study including five diagnostic groups: Major Depressive Disorder (MDD), Schizophrenia, Obsessive-Compulsive Disorder (OCD), Generalized Anxiety Disorder (GAD), and Insomnia

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: March 5, 2026
• Study Start: January 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: present

Locations

EG (1)