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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A comparative cross-sectional study: Major Depressive Disorder | Experimental |
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| A comparative cross-sectional study: Schizophrenia | Experimental |
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| A comparative cross-sectional study: Obsessive-Compulsive Disorder | Experimental |
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| A comparative cross-sectional study ; Generalized Anxiety Disorder | Experimental |
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| comparative cross-sectional study; Insomnia | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS Parameters | Device | 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Elbahy | faculty of medicine | Principal Investigator |
| Mahmoud Abo Salem | faculty of medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine | Cairo | Menofia | 32511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39473161 | Background | 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. | |
| 28229395 | 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. |
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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
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 1, 2023 | Mar 1, 2026 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 1, 2023 | Mar 1, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D009771 | Obsessive-Compulsive Disorder |
| D000098647 | Generalized Anxiety Disorder |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D001523 | Mental Disorders |
| D012559 | Schizophrenia |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
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A comparative cross-sectional study including five diagnostic groups:
Major Depressive Disorder (MDD), Schizophrenia, Obsessive-Compulsive Disorder (OCD), Generalized Anxiety Disorder (GAD), and Insomnia
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| 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. |
| D012893 |
| Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |