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

NCT06874374 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

  • Depression - Major Depressive Disorder
  • Transcranial Alternating Current Stimulation

Interventions

DEVICE

Closed-loop tACS

Individual alpha tACS

DEVICE

Sham Comparator

Sham stimulation

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • Pulvinar Neuro, LLC

    lead INDUSTRY

Principal Investigators

  • David Rubinow, MD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-11
Primary Completion
2026-05-22
Completion
2026-06-22
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06874374 on ClinicalTrials.gov