Generalized Anxiety Disorder, Insomnia, Major Depressive Disorder (MDD), Obsessive-Compulsive Disorder, SCHIZOPHRENIA 1 (Disorder)
Conditions
Keywords
Transcranial direct current stimulation, neuromodulation, psychiatric disorders, major depressive disorder, schizophrenia, obsessive-compulsive disorder, anxiety disorders, insomnia
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.
Interventions
DEVICEtDCS 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.
Sponsors
Menoufia University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A comparative cross-sectional study including five diagnostic groups: Major Depressive Disorder (MDD), Schizophrenia, Obsessive-Compulsive Disorder (OCD), Generalized Anxiety Disorder (GAD), and Insomnia
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Åsberg Depression Rating Scale | 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) |
| Positive and Negative Syndrome Scale | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Yale-Brown Obsessive Compulsive Scale | 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). |
| Generalized Anxiety Disorder-7 | 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). |
| Insomnia Severity Index - 7 items | 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). |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORMohamed Elbahy
faculty of medicine
STUDY_DIRECTORMahmoud Abo Salem
faculty of medicine
Outcome results
None listed