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

Not Applicable

Completed

• Conditions: Depression; Major Depressive Disorder; TACS
• Interventions: Device: Closed-loop tACS

• Registration Number: NCT05772702
• Lead Sponsor: Electromedical Products International, Inc.

Brief 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.

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.

Study Timeline

• Study Start: 2023-02-13
• Study First Submitted: 2023-02-24
• Study First Submitted QC: 2023-03-06
• Study First Posted: 2023-03-16
• Primary Completion: 2024-04-22
• Study Completion: 2024-08-19
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Closed-loop tACS	Closed-loop tACS	Closed-loop individual alpha tACS daily for five consecutive days.

Primary Outcome Measures

Name	Time	Method
HDRS-17 change	19 days	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.

Secondary Outcome Measures

Name	Time	Method
Change in Snaith-Hamilton Pleasure Scale (SHAPS)	19 days	Change in SHAPS at D5, FU1, FU2; minimum value is 0, maximum value is 14. Higher scores indicate worse outcome.
Response/Remission of depression	19 days	Number of response/remission rates at D5 and FU2
Change in Altman Self-Rating Mania Scale (ASRM)	19 days	Change in ASRM at D5, FU1, FU2; minimum value is 0, maximum value is 20. Higher scores indicate worse outcome.
Change in Depression Anxiety and Stress Scale (DASS-42)	19 days	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.
Change in Clinical Global Impression Scale (CGI)	19 days	Change in CGI at Day 5, 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.
HDRS-17 change	5 days	Change in HDRS-17 between D5 and D1
Change in Quick Inventory of Depressive Symptomatology (QIDS)	19 days	Change in QIDS at D5, FU1, FU2; minimum value is 0, maximum value is 27. Higher scores indicate worse outcome.
Change in State-Train Anxiety Inventory (STAI)	19 days	Change in STAI at D5, FU1, FU2; minimum value is 20, maximum value is 80. Higher scores indicate worse outcome.
Change in Quality of Life Enjoyment and Satisfaction Questionnaire, short form (Q-LES-Q-SF)	19 days	Change in Q-LES-Q-SF at D5, FU1, FU2; minimum value is 14, maximum value is 70. Higher scores indicate better outcome.

Trial Locations

Locations (1)

Carolina Center for Neurostimulation; 🇺🇸 Chapel Hill, North Carolina, United States