Trials / Recruiting
RecruitingNCT06874374
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Pulvinar Neuro, LLC · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The purpose of this study is to investigate device feasibility and performance of the XCSITE 100 Pro V2 device and assess preliminary efficacy of closed-loop transcranial alternating current stimulation (CL-tACS) for reducing symptoms of major depressive disorder (MDD) in a double-blind, sham-controlled, parallel group, single-site clinical trial. A total of 40 participants will be randomized to receive active or sham CL-tACS via carbon-silicone electrodes for up to 40 minutes over 5 consecutive days. Device feasibility and performance data will be collected from every stimulation session. Clinical assessments of depression and related symptoms will be performed at Baseline (Day 1), End Of Treatment (EOT; Day 5), and Follow-Up (FUP, 2-weeks post-treatment, Day 19). High-density electroencephalography (HD-EEG) will be performed at Baseline, EOT and FUP. An optional MRI will be performed up to 30 days before, or on Baseline, to provide anatomical data for EEG brain connectivity analysis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Closed-loop tACS | Individual alpha tACS |
| DEVICE | Sham Comparator | Sham stimulation |
Timeline
- Start date
- 2025-04-11
- Primary completion
- 2025-12-31
- Completion
- 2026-02-28
- First posted
- 2025-03-13
- Last updated
- 2025-04-16
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06874374. Inclusion in this directory is not an endorsement.