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

NCT ID: NCT05772702

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-13
• Study Completion Date: 2024-08-19

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.

Conditions

Depression; Major Depressive Disorder; tACS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Closed-loop tACS

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

Group Type: EXPERIMENTAL

Closed-loop tACS

Intervention Type: DEVICE

Individual alpha tACS

Interventions

Closed-loop tACS

Individual alpha tACS

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

Electromedical Products International, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David R Rubinow, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

Carolina Center for Neurostimulation

Chapel Hill, North Carolina, United States

Countries

United States

References

Alexander ML, Alagapan S, Lugo CE, Mellin JM, Lustenberger C, Rubinow DR, Frohlich F. Double-blind, randomized pilot clinical trial targeting alpha oscillations with transcranial alternating current stimulation (tACS) for the treatment of major depressive disorder (MDD). Transl Psychiatry. 2019 Mar 5;9(1):106. doi: 10.1038/s41398-019-0439-0.

Reference Type: BACKGROUND

PMID: 30837453 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://researchforme.unc.edu/index.php/en/study-details?rcid=4419

Link to more information and study recruitment for interested potential participants.

Other Identifiers

22-3094

Identifier Type: -

Identifier Source: org_study_id