Actively Recruiting
Pilot Study of Personalized Aperiodic Transcranial Alternating Current Stimulation in Antenatal Depression (PandA-tACS)
Led by University of North Carolina, Chapel Hill · Updated on 2026-04-09
10
Participants Needed
1
Research Sites
68 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
B
Brain & Behavior Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pilot Study of Personalized Aperiodic Transcranial Alternating Current Stimulation in Antenatal Depression (PandA-tACS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 45 years
- Ability to understand study risks and benefits and provide informed consent
- Willingness to follow all study procedures and be available for the entire study
- Low suicide risk: no active suicidal thoughts in past month and no suicide attempts or significant self-harm in past 2 years
- For healthy controls: use of highly effective contraception for at least 1 month before screening and during study
- For antenatal depression group: between 14 and 32 weeks of single viable pregnancy
- Receiving established obstetric care through UNC
- Confirmed diagnosis of unipolar, non-psychotic major depressive disorder
- Hamilton Depression Rating Scale (HDRS-17) score of 8 or higher
You will not qualify if you...
- Diagnosis of severe alcohol use disorder in past 12 months
- Diagnosis of moderate to severe substance use disorder (excluding tobacco) in past 12 months
- History of bipolar disorder
- History of schizophrenia spectrum or other psychotic disorders
- History of autism spectrum disorder
- Started new psychotropic medication or changed dose in last 6 weeks
- Started new psychotherapy in last 6 weeks
- Received neurostimulation treatment in last 6 weeks
- History of seizures (except childhood febrile seizures or ECT-induced seizures)
- Neurological disorders increasing risk or confounding results (e.g., dementia, stroke, Parkinson's, multiple sclerosis, traumatic brain injury with prolonged unconsciousness, ruptured aneurysm, CNS radiation)
- Previous non-response to ECT or TMS
- Prior brain surgery or brain implants
- Implanted electrical medical devices
- Currently enrolled in another depression clinical trial
- Unstable medical conditions or risks preventing study completion
- For healthy controls: currently pregnant or breastfeeding, and history of depression
- For antenatal depression group: history of diabetes, pre-term delivery, eclampsia, severe pre-eclampsia, asthma needing daily meds, chronic hypertension, immune thrombocytopenia, hyperthyroidism needing meds, BMI 40+, in vitro fertilization, uterine anomalies, organ transplant, history of clotting disorders or anticoagulation plans, fetal autoimmune hydrops, abnormal placenta
- Current pregnancy with HIV/Hep B/C with detectable viral load, anemia (hemoglobin below 11.0), no prenatal visits by week 15, placenta previa or accreta, pre-eclampsia, gestational diabetes or hypertension, fetus with abnormal chromosomes, short cervix (<2.5 cm), cerclage or vaginal progesterone use, fetal growth restriction, macrosomia, polyhydramnios, oligohydramnios, membrane rupture, severe morning sickness, confirmed chromosomal trisomy testing, persistent congenital anomalies, or other high-risk pregnancy conditions as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Carolina Center for Neurostimulation
Chapel Hill, North Carolina, United States, 27516
Actively Recruiting
Research Team
A
Athena Stein, PhD
CONTACT
Z
Zachary Stewart
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
2
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