RecruitingNot ApplicableNCT06874374

Individualized Non-invasive Brain Stimulation for the Treatment of Major Depressive Disorder

Closed-Loop Transcranial Alternating Current Stimulation (CL-tACS) for the Treatment of Major Depressive Disorder: Double-Blind, Sham-Controlled Randomized Pilot Study


Sponsor

Pulvinar Neuro, LLC

Enrollment

40 participants

Start Date

Apr 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this research study is to study a closed-loop transcranial alternating current stimulation (tACS) device to evaluate feasibility of the product in a clinical trial and collect preliminary data on potential effects on symptoms of depression in people with major depressive disorder.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized, non-invasive brain stimulation technique (like targeted magnetic or electrical pulses to the brain) as a treatment for major depressive disorder (MDD) — severe depression — in people who have not responded well enough to medications. **You may be eligible if...** - You are between 18 and 70 years old - You have a confirmed diagnosis of major depressive disorder (unipolar, non-psychotic) - Your depression symptoms are at least moderate in severity (HDRS-17 score of 14 or above) - You have low suicide risk (no active suicidal thoughts in the past month, no attempts in the past 2 years) - You are willing to follow all study procedures **You may NOT be eligible if...** - You have a severe alcohol use disorder in the past year - You have a moderate-to-severe substance use disorder (other than tobacco) in the past year - You have a psychotic illness or bipolar disorder - You have medical conditions that make brain stimulation unsafe (such as certain metal implants in the head) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEClosed-loop tACS

Individual alpha tACS

DEVICESham Comparator

Sham stimulation


Locations(1)

Carolina Center for Neurostimulation

Chapel Hill, North Carolina, United States

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NCT06874374


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