N/A
N=26
Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Depression
Depression · Major Depressive Disorder · tACS
Bottom Line
View on ClinicalTrials.gov: NCT05772702 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Change in Hamilton Depression Rating Scale 17-item (HDRS-17) — -12.04 units on a scale — p=<0.0005
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Closed-loop tACS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Electromedical Products International, Inc.
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hamilton Depression Rating Scale 17-item (HDRS-17) |
-8.36 | <0.0005 sig |
| SECONDARY Change in Hamilton Depression Rating Scale 17-item (HDRS-17) |
-8.36 | <0.0005 sig |
| SECONDARY Response/Remission of Depression |
12; 13; 21; 4; 10; 15 | — |
| SECONDARY Change in Quick Inventory of Depressive Symptomatology (QIDS) |
-3.88; -5.96; -7.48 | <0.0005 sig |
| SECONDARY Change in Altman Self-Rating Mania Scale (ASRM) |
0.88; 1.92; 1.92 | <0.0005 sig |
| SECONDARY Change in Snaith-Hamilton Pleasure Scale (SHAPS) |
-2.60; -3.48; -3.76 | <0.0005 sig |
| SECONDARY Change in Depression Anxiety and Stress Scale (DASS-42) |
-12.52; -21.44; -24.08; -6.52; -11.00; -12.20 | <0.0005 sig |
| SECONDARY Change in State-Train Anxiety Inventory (STAI) |
-3.08; -5.16; -6.16 | 0.021 sig |
| SECONDARY Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF) |
— | — |
| SECONDARY Change in Clinical Global Impression Scale (CGI) |
2.56; 1.68; 4.04; 2.36; 1.76 | <0.0005 sig |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05772702). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.