Brain Stimulation for Depression
(CL-tACS RCT Trial)

Recruiting in Palo Alto (17 mi)

Overseen byDavid Rubinow, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Pulvinar Neuro, LLC

No Placebo Group

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for individuals with major depressive disorder who are interested in a non-invasive treatment option. Specific eligibility criteria details were not provided, so participants should inquire about inclusion and exclusion factors.

Inclusion Criteria

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

I am between 18 and 70 years old.

+5 more

Exclusion Criteria

I have not had any neurostimulation treatments in the last 6 weeks.

For the optional MRI session only: Contraindication to MRI according to MRI Screening Form

DSM-5 diagnosis of severe alcohol use disorder (AUD) within the last 12 months, as evidenced by the DIAMOND

+14 more

Participant Groups

The study tests a closed-loop transcranial alternating current stimulation (tACS) device against a sham comparator to see if it's feasible in trials and if it can improve depression symptoms.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active Closed-loop tACSExperimental Treatment1 Intervention

Closed-loop individual alpha tACS daily for five consecutive days.

Group II: Sham Closed-loop tACSPlacebo Group1 Intervention

Sham closed-loop individual alpha tACS daily for five consecutive days.