Pulvinar Neuro, LLC
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
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 Follo…
Inclusion Criteria: 1. ≥ 22 years of age; 2. with at least moderate symptom severity (HAM-D17 ≥ 17); 3. who are currently in a depressive episode; 4. 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; 5. 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) and agree to continue the same regimen throughout study p…
Individual alpha tACS
Sham stimulation
Arctuva estimate
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