NCT06874374

Brief Summary

The purpose of this research study is to study a closed-loop transcranial alternating current stimulation (tACS) device to evaluate feasibility of the product in a clinical trial and collect preliminary data on potential effects on symptoms of depression in people with major depressive disorder.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
29 days until next milestone

Study Start

First participant enrolled

April 11, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

April 16, 2025

Status Verified

March 1, 2025

Enrollment Period

9 months

First QC Date

January 28, 2025

Last Update Submit

April 11, 2025

Conditions

Depression - Major Depressive DisorderTranscranial Alternating Current Stimulation

Keywords

tACSDepressionMajor Depressive DisorderTranscranial Alternating Current Stimulation

Outcome Measures

Primary Outcomes (4)

  • Correct Assignment by Device of Study Arm

    Successful assignment by device software to correct study arm for each participant for each session, Day 1 (D1) through Day 5 (D5). Measured as percentage of successful assignments compared to intended programming.

    5 days

  • Accuracy of Device Study Arm Parameters by Device

    Verification of correct study arm parameters applied by device for each participant for each session, Day 1 (D1) through Day 5 (D5).

    5 days

  • Accuracy of Stimulation Initiation Based on EEG by Device

    Verification of correct stimulation initiation decisions for each evaluated EEG window by device for each participant for each session, Day 1 (D1) through Day 5 (D5).

    5 days

  • Accuracy of Device Logs Uploaded to Cloud by Device

    Verification of equivalence between logs stored on local device and corresponding logs uploaded to cloud for each participant for each session, Day 1 (D1) through Day 5 (D5).

    5 days

Secondary Outcomes (2)

  • HDRS-17 Change

    21 Days

  • Change in Alpha Oscillation Power

    5 Days

Other Outcomes (8)

  • Change in Alpha Oscillation Power and Connectivity

    21 Days

  • Remission Rate

    21 Days

  • Response Rate

    21 Days

  • +5 more other outcomes

Study Arms (2)

Active Closed-loop tACS

EXPERIMENTAL

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

Device: Closed-loop tACS

Sham Closed-loop tACS

SHAM COMPARATOR

Sham closed-loop individual alpha tACS daily for five consecutive days.

Device: Sham Comparator

Interventions

Closed-loop tACSDEVICE

Individual alpha tACS

Also known as: CL-tACS
Active Closed-loop tACS
Sham ComparatorDEVICE

Sham stimulation

Sham Closed-loop tACS

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any gender, aged 18 - 70
  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • DSM-5 diagnosis of unipolar, non-psychotic MDD as evidenced by the DIAMOND
  • HDRS-17 score ≥14
  • Low suicide risk (defined for this study as no active suicidal ideation in the past month and no suicide attempts, preparatory actions, or significant non-suicidal self-harm in the previous 2 years). Risk will be assessed utilizing the C-SSRS screen and triage version with further exploration of positive responses.
  • Capacity to understand all relevant risks and potential benefits of the study (informed consent)
  • For people of childbearing potential: use of highly effective contraception as determined by the Investigator for at least 1 month prior to screening and agreement to use such a method during study participation

You may not qualify if:

  • DSM-5 diagnosis of severe alcohol use disorder (AUD) within the last 12 months, as evidenced by the DIAMOND
  • DSM-5 diagnosis of moderate to severe substance use disorder (excluding tobacco) within the last 12 months, as evidenced by the DIAMOND
  • Lifetime history of bipolar disorder, as evidenced by DIAMOND
  • Schizophrenia spectrum and other psychotic disorders, as evidenced by DIAMOND
  • History of autism spectrum disorder
  • Initiated any new psychotropic medication in the 6 weeks prior to screening or had a dose change in the preceding 6 weeks
  • Initiated a new course of psychotherapy in the 6 weeks preceding screening
  • Received any neurostimulation treatment in the 6 weeks preceding screening
  • History of seizures (excluding febrile seizures in childhood or Electroconvulsive Therapy (ECT) induced seizures)
  • Neurological disorders that would increase risk of participation or present a significant confounder in the opinion of the investigator (for example, dementia, history of stroke, Parkinson's disease, multiple sclerosis, history of traumatic brain injury with prolonged loss of consciousness, ruptured cerebral aneurysm, previous CNS radiation)
  • Previously failed to respond to ECT or transcranial magnetic stimulation (TMS)
  • Prior brain surgery and/or brain implants
  • Implanted medical device that uses electricity
  • Current pregnancy or lactation
  • Currently enrolled in another clinical trial for depression
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carolina Center for Neurostimulation

Chapel Hill, North Carolina, 27516, United States

RECRUITING

Related Publications (2)

  • Schwippel T, Pupillo F, Feldman Z, Walker C, Townsend L, Rubinow D, Frohlich F. Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Major Depressive Disorder: An Open-Label Pilot Study. Am J Psychiatry. 2024 Sep 1;181(9):842-845. doi: 10.1176/appi.ajp.20230838. Epub 2024 Aug 7. No abstract available.

    PMID: 39108159BACKGROUND

  • 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.

    PMID: 30837453BACKGROUND

MeSH Terms

Conditions

DepressionDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental Disorders

Study Officials

  • David Rubinow, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Athena Stein, PhD

CONTACT

919-966-9929astein1@email.unc.edu

Zachary Stewart

CONTACT

zachary_stewart@med.unc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2025

First Posted

March 13, 2025

Study Start

April 11, 2025

Primary Completion

December 31, 2025

Study Completion

February 28, 2026

Last Updated

April 16, 2025

Record last verified: 2025-03

Locations

US(1)