Not Yet RecruitingNot Applicable

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

214 participantsStarted 2025-12

Plain-language 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

Who can participate

Age range22 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. ≥ 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;
✓. 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;

Exclusion criteria

✕. 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;

What they're measuring

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

Timeframe: Timeframe: Baseline to Week 3

Trial details

NCT IDNCT07282678

SponsorPulvinar Neuro, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

James McCall, PhD

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

View on ClinicalTrials.gov More Depression - Major Depressive Disorder trials