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
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Menofia
-
Cairo, Menofia, Egypt, 32511
- Faculty of Medicine
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: A comparative cross-sectional study: Major Depressive Disorder
|
Preparation:
Stimulation: Ramp-up current over 30 sec to avoid discomfort. Monitor for adverse effects (tingling, itching, headache ). Post-Stimulation Assessment:
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
|
Preparation:
Stimulation: Ramp-up current over 30 sec to avoid discomfort. Monitor for adverse effects (tingling, itching, headache ). Post-Stimulation Assessment:
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
|
Preparation:
Stimulation: Ramp-up current over 30 sec to avoid discomfort. Monitor for adverse effects (tingling, itching, headache ). Post-Stimulation Assessment:
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
|
Preparation:
Stimulation: Ramp-up current over 30 sec to avoid discomfort. Monitor for adverse effects (tingling, itching, headache ). Post-Stimulation Assessment:
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
|
Preparation:
Stimulation: Ramp-up current over 30 sec to avoid discomfort. Monitor for adverse effects (tingling, itching, headache ). Post-Stimulation Assessment:
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
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Montgomery-Åsberg Depression Rating Scale
Time Frame: The assessment period for each participant was 24 weeks from the start of their participation in the study.
|
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
Time Frame: The assessment period for each participant was 24 weeks from the start of their participation in the study.
|
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
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Yale-Brown Obsessive Compulsive Scale
Time Frame: The assessment period for each participant was 24 weeks from the start of their participation in the study.
|
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
Time Frame: The assessment period for each participant was 24 weeks from the start of their participation in the study.
|
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
Time Frame: The assessment period for each participant was 24 weeks from the start of their participation in the study.
|
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
Sponsor
Investigators
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)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
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
Other Study ID Numbers
- 11/2025 com7
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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