Intensive tDCS for MDD: Feasibility Study

Study Overview
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Brief Summary
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This will be a prospective, open-label, single-arm study to determine the safety and feasibility of an intensive treatment of transcranial direct current stimulation (tDCS) for major depressive disorder (MDD). Participants will be age 18-65 with a diagnosis of unipolar MDD. Participants will receive an intensive treatment of tDCS over a 10-day treatment period and complete follow-up assessments at the end of treatment, 1, and 4 weeks post-treatment.

Detailed Description
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This will be a prospective, open-label, single-arm study to determine the safety and feasibility of an intensive treatment of transcranial direct current stimulation (tDCS) for major depressive disorder (MDD). Secondary objective is to gather preliminary data on the clinical effects of the protocol. After assessment and inclusion into the study, participants will receive up to 50 tDCS sessions over 10 days. Study procedures: Daily assessments: brief questions before and after each tDCS session to evaluate potential adverse events as well as a verbal rating scale for pain. Questionnaires : a battery of mood questionnaires will be completed to inform findings regarding clinical effects of the treatment. Cognitive measures: a short cognitive assessment will be completed to inform findings regarding cognitive safety of the treatment.

Official Title
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Intensive Transcranial Direct Current Stimulation in the Treatment of Major Depression: Feasibility Study

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Device: transcranial direct current stimulation (tDCS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Major unipolar depression for at least 4 weeks meeting the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) and the Mini International Neuropsychiatric Interview (M.I.N.I) Age between 18 to 65 Minimum score of 17 on the GRID-Hamilton Depression Rating Scale (GRID-HAMD) Exclusion Criteria: Bipolar disorder, Psychosis Active substance use disorder (in the last 3 months) Personality disorder Neurocognitive disorder High risk of suicide Major comorbid medical or neurological condition Pregnancy Medical contraindications to tDCS: Ferromagnetic material in the skull Defect in the bone substance of the skull Dermatological condition (e.g. eczema, psoriasis, urticaria, dermatitis, acne, hyperhidrosis, folliculitis, rosacea, keratosis, herpes, infectious or neoplastic phenomenon, etc.) Skin lesion on the skull (ex: cuts, abrasions, rash, tattoos on the skull, piercings on the head, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open label feasibility study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active tDCS<br>Will be receiving active intensive tDCS treatment | Device: transcranial direct current stimulation (tDCS)<br>* tDCS alters brain excitability using a weak electric field induced through two electrodes and could potentially improve symptoms of depression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility-related endpoints - adherence to tDCS | Number of completed treatment sessions | after 10 days of treatment sessions | 
| Feasibility-related endpoints - retention rates | number of patients who did not completed the total (50) sessions | after 10 days of treatment sessions | 
| Adverse Events reported | Adverse Events reported | up to one month after end of the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate (> 50% improvement) and remission rate (score <7) using GRID-Hamilton Depression Rating Scale (GRID-HAMD) | Response rate (> 50% improvement) and remission rate (score <7) using GRID-HAMD scale. (score 0-7= not depressed; very severe >23). | T1 (one week after end of the treatment) and T2 (one month after end of the treatment) | 
| Percentage change on Hamilton Rating Scale for Depression (HAMD-6) | Percentage change on Hamilton Rating Scale for Depression (HAMD-6) | T0 (baseline) and T2 (one month after the end of the treatment) | 
| Percentage change on Patient Health Questionnaire (PHQ-9) | Percentage change on Patient Health Questionnaire (PHQ-9) | T0 (baseline) and T2 (one month after the end of the treatment) | 
| Percentage change on General Anxiety Disorder (GAD-7) | Percentage change on General Anxiety Disorder (GAD-7) | T0 (baseline) and T2 (one month after the end of the treatment) | 
| Percentage change on Rey Auditory Verbal Learning Scale (RAVLT). | Cognitive safety. Percentage change on Rey Auditory Verbal Learning Scale. total learning. (Minimum score 0 and maximum score 75, higher score means better outcome) | T0 (baseline) and T1 (one week after end of the treatment) | 
| Percentage change on Rey-Osterrieth Complex Figure (ROCF) | Percentage change on Rey-Osterrieth Complex Figure (ROCF), total score immediate recall. (Minimum score 0 and maximum score 36, higher score means better outcome | T0 (baseline) and T1 (one week after end of the treatment) | 
| Percentage change on Trail Making Test parts A&B | Percentage change on Trail Making Test. Total time needed for completion on part B. (no minimum and maximum time) | T0 (baseline) and T1 (one week after end of the treatment) | 
| Percentage change on the Controlled Oral Word Association (COWAT) | Percentage change on the Controlled Oral Word Association (COWAT). (Minimum score: 0; Maximum score: no maximum; higher score means better outcome). | T0 (baseline) and T1 (one week after end of the treatment) |