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

NCT05772702 | Completed Results FDA Device

• 1 other identifier: 22-3094
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Major Depressive Disorder; tACS

Outcome Measures

Primary Outcomes (1)

• Change in Hamilton Depression Rating Scale 17-item (HDRS-17)

  Change in HDRS-17 from Day 1 (D1) to Day 19 (i.e., two week follow-up; FU2); HDRS-17 minimum value is 0, maximum value is 52. Higher scores indicate worse outcome. Negative scores indicate improved outcomes.

  Day 1 to Day 19 (i.e. 19 days)

Secondary Outcomes (9)

• Change in Hamilton Depression Rating Scale 17-item (HDRS-17)

  Day 1 to Day 5 (i.e., 5 days)

• Response/Remission of Depression

  Day 5 and Day 19

• Change in Quick Inventory of Depressive Symptomatology (QIDS)

  Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)

• Change in Altman Self-Rating Mania Scale (ASRM)

  Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)

• Change in Snaith-Hamilton Pleasure Scale (SHAPS)

  Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)

Other Outcomes (8)

• Change in Alpha Oscillation Power

  19 days

• Change in Quick Inventory of Depressive Symptomatology (QIDS) Over 12 Weeks

  89 days

• Change in Altman Self-Rating Mania Scale (ASRM) Over 12 Weeks

  89 days

Study Arms (1)

Closed-loop tACS

EXPERIMENTAL

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

Device: Closed-loop tACS

Interventions

Closed-loop tACS DEVICE

Individual alpha tACS

Closed-loop tACS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Electromedical Products International, Inc.: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Carolina Center for Neurostimulation

Chapel Hill, North Carolina, 27516, United States

Location

Related Publications (1)

• 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: 30837453 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Christopher Walker
• Organization: Pulvinar Neuro

chris.walker@pulvinarneuro.com

8043173403

Study Officials

• David R Rubinow, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-Label

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 16, 2023
• Study Start: February 13, 2023
• Primary Completion: April 22, 2024
• Study Completion: August 19, 2024
• Last Updated: May 29, 2025
• Results First Posted: May 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)