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

Last updated: January 15, 2025
Sponsor: Electromedical Products International, Inc.
Overall Status: Completed

Phase

N/A

Condition

Depression

Affective Disorders

Depression (Adult And Geriatric)

Treatment

Closed-loop tACS

Clinical Study ID

NCT05772702
22-3094
  • Ages 18-70
  • All Genders

Study 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

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

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

Total Participants: 26
Treatment Group(s): 1
Primary Treatment: Closed-loop tACS
Phase:
Study Start date:
February 13, 2023
Estimated Completion Date:
August 19, 2024

Study 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.

Connect with a study center

  • Carolina Center for Neurostimulation

    Chapel Hill, North Carolina 27516
    United States

    Site Not Available

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