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

NCT06979154 | Recruiting FDA Device

• 1 other identifier: 25-0425
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Antenatal Depression; Healthy Controls; Major Depressive Disorder; Major Depressive Disorder in Pregnancy

Keywords

Behavioral Symptoms; Mood Disorders; Mental Disorders; Depression; Depressive Disorder; Major Depressive Disorder; Antenatal diagnoses; Prenatal diagnoses; Pregnancy; Electric Stimulation; non-invasive brain stimulation; transcranial alternating current stimulation; tACS; EEG; antenatal depression; Healthy Controls; Aperiodic brain activity

Outcome Measures

Primary Outcomes (6)

• Safety via the presence of any serious AEs related to stimulation

  The number of serious adverse events reported in healthy control and antenatal depression groups.

  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

  The number of participants enrolled relative to the target recruitment of five participants in each of the healthy control and antenatal depression groups over the specified 12-month period

  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

  The number of participants who complete all study visits within the intervention and follow-up period in the healthy control and antenatal depression groups.

  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'

  The number of participants who rate stimulation-related sensations as 'high' within the intervention period in the healthy control and antenatal depression groups.

  Day 1 to Day 5

• Tolerability via the proportion of participants reporting intolerance to stimulation

  The proportion of participants who are unable to tolerate stimulation within the intervention period in the healthy control and antenatal depression groups.

  Day 1 to Day 5

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

  The number of adverse birth outcomes in participants with antenatal depression. Review will consider length of pregnancy in days, delivery (spontaneous, induced, cesarian (planned or acute), vaginal birth, forceps and/or vacuum extraction), gestational age at birth, Apgar 5 min, malformation, child weight at birth in grams, birth size (small for gestational age, appropriate for gestational age, large for gestational age), neonatal need for intensive care, stillbirth, maternal length of stay in hospital, maternal need for intensive care, pre-eclampsia, as well as EPDS score between 2-4 weeks post-delivery .

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

Other Outcomes (11)

• Change in aperiodic exponent following the five-day PandA-tACS intervention

  Day 1 to Day 5

• Change in HDRS-17 score following intervention in the antenatal depression population

  Day 1 up to Follow-up 1 (2 weeks post-stimulation)

• Change in Edinburgh Postnatal Depression Scale (EPDS) in the antenatal depression population

  Day 1 up to Follow-up 1 (2 weeks post-stimulation)

Study Arms (2)

Healthy Control Group

EXPERIMENTAL

Aperiodic tACS delivered using a waveform based on individual participant EEG activity which has been modified to alter excitation/inhibition balance.

Device: tACS (aperiodic)

Antenatal Depression Group

EXPERIMENTAL

Aperiodic tACS delivered using a waveform based on individual participant EEG activity which has been modified to alter excitation/inhibition balance.

Device: tACS (aperiodic)

Interventions

tACS (aperiodic) DEVICE

Individualized tACS waveform based on aperiodic EEG activity will be delivered.

Antenatal Depression Group; Healthy Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 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 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

Sponsors & Collaborators

• Michigan State University: collaborator
• University of North Carolina, Chapel Hill: lead
• Brain & Behavior Research Foundation: collaborator

Study Sites (1)

Carolina Center for Neurostimulation

Chapel Hill, North Carolina, 27516, United States

RECRUITING

Related Links

• NeuroConn DC-Stimulator MC

MeSH Terms

Conditions

Depressive Disorder, Major; Behavioral Symptoms; Mood Disorders; Mental Disorders; Depression; Depressive Disorder

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Flavio Frohlich, PhD, MSc ETH, MA

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Athena Stein, PhD

CONTACT

19199669929; athena_stein@med.unc.edu

Zachary Stewart

CONTACT

9199669929; zachary_stewart@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: First phase of study involves healthy controls. Second phase of study involves patients with antenatal depression.

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 18, 2025
• Study Start: August 12, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)