NCT07282678

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

Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Major Depressive Disorder: Double-Blind, Controlled Randomized Multicenter Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 214 (estimated)
• Sponsor: Pulvinar Neuro, LLC · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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

Detailed description

This study examines the efficacy of closed-loop transcranial alternating current stimulation (CL-tACS) for the treatment of major depressive disorder (MDD) in a double-blind, controlled parallel group multi-site clinical trial. 214 participants will be randomized into receiving 5 consecutive days of active or control CL-tACS (1:1 allocation) to achieve approximately 192 participants completing the primary endpoint at week 3, assuming a 10% lost to follow-up rate. Clinical assessments of depression and anxiety symptoms are performed at Screening, Baseline, Day 5, Follow-Up 1 (week 3), and Follow-Up 2 (week 5). Additional assessments of quality of life are included. For subjects who are not considered responders at the Week 3 primary endpoint, there will be a phase 2 retreatment with active CL-tACS which will mirror the same 5-day protocol. Patients in this arm will complete additional data collection at Phase 2 baseline, Phase 2 Day 5, Phase 2 Follow-up 1 (phase 2 week 3), and phase 2 follow-up 2 (phase 2 week 5).

Conditions

• Depression - Major Depressive Disorder
• Transcranial Alternating Current Stimulation

Interventions

Type	Name	Description
DEVICE	Closed-loop tACS	Individual alpha tACS
DEVICE	Sham Comparator	Sham stimulation

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-12-01
• Completion: 2028-01-01
• First posted: 2025-12-15
• Last updated: 2025-12-17

Regulatory

• FDA-regulated device study