RecruitingNot Applicable

Pilot Study of Personalized Aperiodic Transcranial Alternating Current Stimulation in Antenatal Depression (PandA-tACS)

United States10 participantsStarted 2025-08-12

Plain-language summary

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.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Female aged 18 - 45 * Capacity to understand all relevant risks and potential benefits of the study as determined by study staff (provision of informed consent) * Stated willingness to comply with all study procedures and availability for the duration of the study * Low suicide risk (defined for this study as no active suicidal ideation in the past month and no suicide attempts, preparatory actions, or significant non-suicidal self-harm in the previous 2 years). Risk will be assessed utilizing the C-SSRS screen and triage version with further exploration of positive responses. For healthy control population: * Use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation, according to NIH Therapeutics Research Program Guidelines. Additional for antenatal depression population: * Between weeks 14-32 of viable singleton pregnancy * Established obstetric care through UNC * Pre-identified DSM-5 diagnosis of unipolar, non-psychotic MDD which is confirmed by the DIAMOND * HDRS-17 score ≥8 Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: * DSM-5 diagnosis of severe alcohol use disorder (AUD) within the last 12 months, as evidenced by the DIAMOND * DSM-5 diagnosis of moderate to severe substance…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety via the presence of any serious AEs related to stimulation

Timeframe: 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)

Feasibility via the number of participants enrolled relative to the target recruitment in each group

Timeframe: Baseline to end of recruitment period (12 months following recruitment start)

Feasibility via the number of participants completing all study visits within the intervention and follow-up period

Timeframe: Healthy controls: Baseline to Follow-Up (Day 19); antenatal depression group: Baseline to Day 5

Tolerability via the proportion of participants rating stimulation-related sensations as 'high'

Timeframe: Day 1 to Day 5

Tolerability via the proportion of participants reporting intolerance to stimulation

Timeframe: Day 1 to Day 5

Safety via review of birth outcomes within 90 days of birth in the antenatal depression population

Timeframe: Baseline to end of monitoring (birth outcomes review within 90 days of expected delivery date)

Trial details

NCT IDNCT06979154

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-01

Contact for this trial

Athena Stein, PhD

19199669929 athena_stein@med.unc.edu

View on ClinicalTrials.gov More Antenatal Depression trials

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Safety via the presence of any serious AEs related to stimulation

Timeframe: 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)

Feasibility via the number of participants enrolled relative to the target recruitment in each group

Timeframe: Baseline to end of recruitment period (12 months following recruitment start)

Feasibility via the number of participants completing all study visits within the intervention and follow-up period

Timeframe: Healthy controls: Baseline to Follow-Up (Day 19); antenatal depression group: Baseline to Day 5

Tolerability via the proportion of participants rating stimulation-related sensations as 'high'

Timeframe: Day 1 to Day 5

Tolerability via the proportion of participants reporting intolerance to stimulation

Timeframe: Day 1 to Day 5

Safety via review of birth outcomes within 90 days of birth in the antenatal depression population

Timeframe: Baseline to end of monitoring (birth outcomes review within 90 days of expected delivery date)