Recruiting

PandA-tACS & IAF-tACS

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT07799480

Conditions

Antenatal Depression

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Sham (placebo) tACS

IAF-tACS

PandA-tACS

Study Details

Brief summary:

The purpose of this pilot trial is to primarily assess safety, feasibility, and tolerability of PandA-tACS in antenatal depression and determine whether a single PandA-tACS session produces greater left dlPFC aperiodic slope flattening (reduction) from pre- to post-stimulation than IAF-tACS and sham.

Conditions

Antenatal Depression

Study ID

NCT07799480

Start date

Nov, 2026

Status verified date

Oct, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

sham comparator: Inactive Sham (placebo)

Participants will receive sham tACS. Sham stimulation mimics all procedures used in active stimulation.

active comparator: Active IAF-tACS: Experimental Arm

Participants will receive active IAF-tACS delivered at the participant's individual alpha frequency, as measured by EEG. 2mA will be delivered at Cz, and 1 mA (antiphase) split between F3/F4 (in phase). IAF-tACS is delivered in 4 x blocks of 10 min, separated by 2 min HD-EEG.

experimental: Active PandA-tACS: Experimental Arm

Participants will receive active PandA-tACS delivered with the participant's flatter aperiodic slope, as measured by EEG. 2mA will be delivered at Cz, and 1 mA (antiphase) split between F3/F4 (in phase). PandA-tACS is delivered in 4 x blocks of 10 min, separated by 2 min HD-EEG.

Interventions

Sham (placebo) tACS

Participants will be fitted with the same electrode setup and receive sham (placebo) tACS delivered using the neuroConn DC Stimulator MC.

IAF-tACS

Participants will be fitted with the same electrode setup and receive IAF-tACS delivered using the neuroConn DC Stimulator MC.

PandA-tACS

Participants will be fitted with the same electrode setup and receive PandA-tACS delivered using the neuroConn DC Stimulator MC.

Primary outcome measure

  • Safety via the presence of any serious AEs [ Time Frame: Day 1 to within 90 days of expected delivery date. ]
  • Tolerability of PandA-tACS [ Time Frame: Immediately after intervention ]
  • Feasibility of PandA-tACS [ Time Frame: Through completion of the study, roughly 2 years ]
  • Change in aperiodic slope in the dlPFC region. [ Time Frame: Immediately before and after 40 minutes of stimulation (on single interventional session day). ]

Central Contacts and Locations

Central contacts

Locations

Carolina Center for Neurostimulation, Department of Psychiatry, UNC-Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27516

Contacts

Athena Stein, PhD, MPH

919 966 9929ASTER@med.unc.edu

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Nov 3, 2026

Last verified

Oct, 2026

Keywords

  • Non-invasive brain stimulation
  • tACS
  • Neurostimulation
  • Mood Disorders
  • Depression
  • Transcranial Alternating Current Stimulation
  • EEG
  • IAF-tACS
  • Individual Alpha Frequency tACS
  • Antenatal

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-04. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-11-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.