Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Depression
Purpose
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.
Conditions
- Depression
- Major Depressive Disorder
- tACS
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Open-Label
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Closed-loop tACS |
Closed-loop individual alpha tACS daily for five consecutive days. |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Electromedical Products International, Inc.
Study Contact
Detailed Description
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 up to 35 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, FU2) using the Hamilton Depression Rating Scale (HDRS-17). For a subset of patients, electroencephalography (EEG) is collected at D1 prior to stimulation and after stimulation and again at FU2. For a subset of patients, self-scoring surveys will be sent bi-weekly until 12 weeks after treatment.
