Personalized PandA-tACS for Antenatal Depression
Official title: Single Session Personalized Aperiodic Transcranial Alternating Current Stimulation (PandA-tACS) for Antenatal Depression: A Randomized, Sham-Controlled Trial (R61 Phase)
Run by University of North Carolina, Chapel Hill · NCT07799480 · Data updated 2026-11-12
This study tests whether a single personalized brain stimulation session can help pregnant people with depression more than a standard or sham stimulation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Status | Recruiting |
| Started | November 2026 |
| Main results expected | June 2028 |
| Study ends | June 2028 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT07799480 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18-45, 14-32 weeks pregnant with a viable singleton pregnancy, diagnosed with unipolar, non-psychotic major depressive disorder, and at low suicide risk.
✕Probably not a fit
Individuals outside the gestational window, with non-MDD diagnoses, higher suicide risk, or other exclusion criteria may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a pilot, randomized, single-session study in pregnant individuals with unipolar major depressive disorder to assess safety, feasibility, tolerability, and brain effects of PandA-tACS, a personalized, non-invasive brain stimulation. Participants receive PandA-tACS, individualized alpha tACS, or sham stimulation during one in-person visit, with monitoring, EEG, symptom ratings, and safety checks before and after stimulation. Optional MRI for electric-field modeling may be performed, and pregnancy/birth outcomes will be reviewed from medical records. The study aims to see if PandA-tACS produces greater changes in left dlPFC activity compared with other conditions.
Why it matters
Potential benefit: If successful, participants may experience relief from depressive symptoms and gain insight into a safe brain-stimulation option during pregnancy.
How similar studies have gone: Previous non-invasive brain stimulation studies in mood disorders have shown potential benefits, but this is a novel, pregnancy-focused application with PandA-tACS.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * Between weeks 14-32 of viable singleton pregnancy * Currently meet DSM-5 criteria of unipolar, non-psychotic MDD which is confirmed by the DIAMOND * HDRS-17 score ≥8 Exclusion Criteria: * 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 use disorder (excluding tobacco) within the last 12 months, as evidenced by the DIAMOND * Lifetime history of bipolar disorder, as evidenced by DIAMOND * Schizophrenia spectrum and other psychotic disorders, as evidenced by DIAMOND * History of autism spectrum disorder * Initiated any new psychotropic medication in the 6 weeks prior to screening or had a dose change or discontinuation in the preceding 6 weeks * Initiated a new course of psychotherapy in the 6 weeks preceding screening * Received any neurostimulation treatment in the 6 weeks preceding screening * History of seizures (excluding febrile seizures in childhood or Electroconvulsive Therapy (ECT) induced seizures) * Neurological disorders that would increase risk of participation or present a significant confounder in the opinion of the investigator (for example, dementia, history of stroke, Parkinson's disease, multiple sclerosis, history of traumatic brain injury with prolonged loss of consciousness, ruptured cerebral aneurysm, previous CNS radiation) * Previously failed to respond to ECT or transcranial magnetic stimulation (TMS) * Prior brain surgery and/or brain implants * Implanted medical device that uses electricity * Currently enrolled in another clinical trial for depression History of any of the following conditions: * Diabetes (gestational or general history) * Pre-term delivery (\<37 weeks) * Eclampsia * Pre-eclampsia with severe features * Asthma requiring daily medication * Chronic hypertension * Immune thrombocytopenia (ITP) * Hyperthyroidism requiring medication * Pre-pregnancy BMI 40 or more * In vitro fertilization (IVF) * Mullerian anomaly of uterus * Organ transplant * Prior history of deep vein thrombosis/pulmonary embolism (DVT/PE) or plan for anticoagulation during pregnancy * Fetus with autoimmune hydrops * Abnormal placenta Current pregnancy: * HIV/Hep B/Hep C with detectable viral loads * Anemia \[Hemoglobin under 11.0\] upon entry to pre-natal care * No scheduled pre-natal visits by 15 weeks * Placenta previa * Placenta accreta spectrum (PAS) * Pre-eclampsia * Gestational diabetes * Gestational hypertension * Fetus with abnormal chromosomes * Cervical length \< 2.5 cm * Presence of cerclage or vaginal progesterone to decrease chance of pre-term labor * Fetal growth restriction * Macrosomia * Polyhydramnios * Oligohydramnios * Rupture of membranes * Hyperemesis Gravidarum (HEG) * Confirmation testing for Tri 13/18/21 * Congenital anomalies on anatomy ultrasound that do not resolve with follow-up ultrasound
Where it's running
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Carolina Center for Neurostimulation, Department of Psychiatry, UNC-Chapel Hill
Chapel Hill, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Flavio Frohlich, PhD — University of North Carolina, Chapel Hill
- Study coordinator: Flavio Frohlich, PhD
- Email: flavio_frohlich@med.unc.edu
- Phone: 919-966-9929
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.