Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Depression

Study Overview
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Brief Summary
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The purpose of this research study is to study closed-loop transcranial alternating current stimulation (tACS) to determine its effects on symptoms of depression in people with major depressive disorder.

Detailed Description
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The purpose of this clinical trial is to investigate the preliminary efficacy of closed-loop tACS for the treatment of major depressive disorder (MDD) in an open-label pilot study. We will recruit 20 participants with unipolar, non-psychotic MDD. Participation will include seven visits, two of them remotely (with an in-person option as needed), and one electronic survey. Potential participants fill-in an electronic pre-screening form. If potentially eligible, a remote screening visit is performed. If eligible, participants attend five consecutive, daily stimulation sessions. Clinical assessments will be performed at baseline (Day 1 of stimulation, D1), Day five of stimulation (D5), and at their follow-up visit (14 days after the completion of stimulation) using the Hamilton Depression Rating Scale (HDRS-17).

Official Title
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Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Depression (CLACS): Single-Site Open-Label Pilot Study

Conditions
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Depression, Major Depressive Disorder, tACS

Intervention / Treatment
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* Device: Closed-loop tACS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18-70 years Diagnostic and Statistical Manual, 5th Edition (DSM-5) diagnosis of MDD; unipolar, non-psychotic Hamilton Rating Depression Rating Scale (HRDS-17) score >8 Low suicide risk as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) triage form (no intent or plan) Capacity to understand all relevant risks and potential benefits of the study (informed consent) Exclusion Criteria: DSM-5 diagnosis of severe alcohol use disorder (AUD) within the last 12 months. DSM-5 diagnosis of moderate to severe substance use disorder (excluding tobacco) within the last 12 months. Lifetime history of bipolar disorder, psychotic disorder, schizophrenia, autism Current use of benzodiazepines > 20mg diazepam/d equivalent Antidepressant dose change within the last 2 weeks Initiated new antidepressant within the last 4 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Closed-loop tACS<br>Closed-loop individual alpha tACS daily for five consecutive days. | Device: Closed-loop tACS<br>* Individual alpha tACS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDRS-17 change | Change in HDRS-17 between two week follow-up (FU2) and Day 1 (D1); minimum value is 0, maximum value is 52. Higher scores indicate worse outcome. | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDRS-17 change | Change in HDRS-17 between one week follow-up (FU1) and D1 | 14 days | 
| HDRS-17 change | Change in HDRS-17 between D5 and D1 | 5 days | 
| Response/Remission of depression | Number of response/remission rates at D5, FU1 and FU2 | 21 days | 
| Change in Quick Inventory of Depressive Symptomatology (QIDS) | Change in QIDS at D5, FU1, FU2; minimum value is 0, maximum value is 27. Higher scores indicate worse outcome. | 21 days | 
| Change in Altman Self-Rating Mania Scale (ASRM) | Change in ASRM at D5, FU1, FU2; minimum value is 0, maximum value is 20. Higher scores indicate worse outcome. | 21 days | 
| Change in Snaith-Hamilton Pleasure Scale (SHAPS) | Change in SHAPS at D5, FU1, FU2; minimum value is 0, maximum value is 14. Higher scores indicate worse outcome. | 21 days | 
| Change in Depression Anxiety and Stress Scale (DASS-42) | Change in DASS-42 at D5, FU1, FU2; minimum value is 0, maximum value is 126 with three subscales (0 to 42). Higher scores indicate worse outcome. | 21 days | 
| Change in State-Train Anxiety Inventory (STAI) | Change in STAI at D5, FU1, FU2; minimum value is 20, maximum value is 80. Higher scores indicate worse outcome. | 21 days | 
| Change in Quality of Life Enjoyment and Satisfaction Questionnaire, short form (Q-LES-Q-SF) | Change in Q-LES-Q-SF at D5, FU1, FU2; minimum value is 14, maximum value is 70. Higher scores indicate better outcome. | 21 days | 
| Change in Clinical Global Impression Scale (CGI) | Change in CGI at Day 5, FU1 and FU2; CGI scale contains two scoring components, 1) Severity of Illness (0-7) and 2) Global Improvement (0-7). Higher scores in component 1 indicate worse symptoms while higher numbers in component 2 indicate worse clinical outcomes. | 21 days |