Pilot Study of Personalized Aperiodic Transcranial Alternating Current Stimulation in Antenatal Depression (PandA-tACS)
Part of paid clinical trials in Chapel Hill, North Carolina.
- Sponsor
- University of North Carolina, Chapel Hill
- Study ID
- NCT06979154
- Status
- Recruiting
Conditions
- Antenatal Depression
- Healthy Controls
- Major Depressive Disorder
- Major Depressive Disorder in Pregnancy
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 45 Years
- Healthy Volunteers
- Accepted
Interventions
- tACS (aperiodic) — DEVICEIndividualized tACS waveform based on aperiodic EEG activity will be delivered.
Study Details
The purpose of this study is to develop the safety, feasibility, and tolerability of a personalized transcranial alternating current stimulation (tACS) approach in antenatal depression.
Key Dates
- Start date
- Aug 12, 2025
- Status verified
- Apr 2026
- Primary completion
- Dec 1, 2026
- Completion
- Dec 1, 2026
Study Design
- Enrollment
- 10 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- OTHER
Arms
- Experimental: Healthy Control GroupAperiodic tACS delivered using a waveform based on individual participant EEG activity which has been modified to alter excitation/inhibition balance.
- Experimental: Antenatal Depression GroupAperiodic tACS delivered using a waveform based on individual participant EEG activity which has been modified to alter excitation/inhibition balance.
Primary Outcome Measure
Safety via the presence of any serious AEs related to stimulation [ Time Frame: Day 1 to Follow-Up (Day 19) (HC) or Day 1 to end of monitoring (birth outcomes review within 90 days of expected delivery date) (antenatal depression) ]
Central Contacts
- Athena Stein, PhD19199669929
- Zachary Stewart9199669929
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Carolina Center for Neurostimulation | Chapel Hill | North Carolina | 27516 | Flavio Frohlich, PhD (PRINCIPAL_INVESTIGATOR) |
Find similar trials in Chapel Hill, NC
By condition
By specialty
By research site
Related Studies
- Study of ALTO-300 in MDDPHASE2 · Recruiting · Alto Neuroscience · Phoenix, Arizona
- A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive SymptomsPHASE4 · Recruiting · Axsome Therapeutics, Inc. · Bellflower, California
- "A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder"PHASE3 · Recruiting · Cybin IRL Limited · Phoenix, Arizona
- Ovarian Hormone Withdrawal, Anhedonia, and Reward Sensitivity in Women With Premenstrual Exacerbations of DepressionPHASE4 · Recruiting · University of North Carolina, Chapel Hill · Chapel Hill, North Carolina