Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Major Depressive Disorder

NCT07282678 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: PN1000
• Study Type: interventional
• Target: 214
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this research study is to investigate a closed-loop transcranial alternating current stimulation (tACS) device to evaluate its ability to reduce symptoms of major depressive disorder

Conditions

Depression - Major Depressive Disorder; Transcranial Alternating Current Stimulation

Keywords

tACS; Depression; Major Depressive Disorder; Transcranial Alternating Current Stimulation

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale (HDRS) score reduction, Phase 1 Evaluation

  Response rates (at least 50% reduction in HDRS-D17 score) (0-52 score range, higher score is worse)

  Timeframe: Baseline to Week 3

Secondary Outcomes (10)

• Hamilton Depression Rating Scale (HDRS) Score reduction, at study end

  At the phase 1, week 3 assessment OR at the phase 2, week 3 assessment.

• The State-Trait Anxiety Inventory (STAI) Score

  Timeframe: Baseline to week 3, Phase 1

• Hamilton Depression Rating Scale (HDRS) Remission Rate

  Timeframe: Baseline to Week 3, Phase 1

• Hamilton Depression Rating Scale (HDRS) Remission Rate at Baseline Evaluation

  Timeframe: Baseline to Day 5

• Responder rates (at least 50% reduction in Hamilton Depression Rating Scale (HDRS) score)

  Timeframe: Baseline to Day 5

Study Arms (3)

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

Open Label, Active Closed-loop tACS Retreatment

EXPERIMENTAL

An open label, second dose of Closed-loop individual alpha tACS daily for five consecutive days. Assignment to this arm occurs after participation in the closed label active or sham arms.

Device: Closed-loop tACS

Interventions

Closed-loop tACS DEVICE

Individual alpha tACS

Active Closed-loop tACS; Open Label, Active Closed-loop tACS Retreatment

Sham Comparator DEVICE

Sham stimulation

Sham Closed-loop tACS

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 22 years of age;
• with at least moderate symptom severity (HAM-D17 ≥ 17);
• who are currently in a depressive episode;
• who have used at least 1 antidepressant in the current or previous episode, but have not found adequate symptom relief or who were not able to tolerate medication side effects;
• who, for 6 weeks prior to enrollment, are either;
• not taking antidepressant medication, or:
• are taking a stable psychiatric medication regimen with one or more stable antidepressant medication dose(s)
• if currently engaged in depression-focused psychotherapy, have maintained stable frequency of therapy for at least 8 weeks prior to enrollment and agree to continue the same regimen throughout study participation;
• are able and willing to comply with the protocol and follow up schedule and protocol, in the opinion of the investigator;
• who understand English and are able to provide written informed consent;
• who are currently under the care of a psychiatric clinician or a primary care physician for major depressive disorder, and who agree to promptly inform the study staff of any change of psychiatric or mental health providers during study participation;
• who agree to allow any and all forms of communication between the investigators/study staff and their current or past (within 2 years) healthcare providers;
• who agree to provide the names and verifiable contact information (email and mailing addresses, mobile and/or land-line phone numbers, as applicable) for at least two persons (≥ age 18) who reside within a 60-minute drive of their residence and whom the research staff are at liberty to contact, as they deem necessary, to ensure participant safety for the duration of study participation;

You may not qualify if:

• Subjects with current / past six months use of an external stimulation device for MDD, including electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), deep brain stimulation (DBS), or other brain or cranial nerve stimulation;
• Subjects with (lifetime) history of failure to response to an adequate trial of ECT, TMS, or implanted vagus nerve stimulation;
• Subjects who currently receive esketamine, ketamine, or psilocybin treatment
• Subjects who are pregnant or of childbearing potential and not using adequate contraception, as determined by the investigator;
• Subjects who are breastfeeding.
• Subjects whose current depressive episode had onset within 6 months post-partum;
• Presence of active skin disorder on the forehead that could be exacerbated by stimulation electrodes in the opinion of the investigator.
• Subjects with clinical or historical features which, in the opinion of the investigator, make them an inappropriate candidate for participation in this trial;
• Subjects whose current depressive episode has not responded to 3 or more adequate trials of FDA approved antidepressant medications;
• Subjects with current suicidal ideation with plan or intent, or suicidal behavior or preparation in the past 3 months, as determined by CSSRS assessment or by the Investigator;
• Subjects with a history of epilepsy or unexplained seizures, as determined by the Investigator;
• Subjects with a diagnosis or clinical history suggestive of bipolar disorder, hypomania, mania, or psychosis, as determined by the Investigator.
• Subjects currently participating, or intending to participate (during the next 3 months) in another study involving an investigational drug or device treatment that, in the opinion of the investigator, could impact symptoms of MDD or use of the investigational device;
• Subjects with a history of intracranial surgery;
• Subjects with implanted neurostimulators, nonremovable or implanted electrical devices or intracranial metal objects, with the exception of dental metal;

Sponsors & Collaborators

• Pulvinar Neuro, LLC: lead

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

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

Study Officials

• Mark George, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James McCall, PhD

CONTACT

910-447-6576; james.mccall@pulvinarneuro.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 15, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share