Single Session Personalized Aperiodic Transcranial Alternating Current Stimulation (PandA-tACS) for Antenatal Depression (PandA)

September 1, 2026 updated by: University of North Carolina, Chapel Hill

Single Session Personalized Aperiodic Transcranial Alternating Current Stimulation (PandA-tACS) for Antenatal Depression: A Randomized, Sham-Controlled Trial (R61 Phase)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this study is to evaluate the safety, feasibility, tolerability, and brain effects of a single session of a personalized form of non-invasive brain stimulation called PandA-tACS in individuals with antenatal depression. PandA-tACS uses each participant's own EEG activity to create an individualized stimulation waveform. Participants will be females aged 18-45 years who are 14-32 weeks pregnant with a viable, low-risk singleton pregnancy and meet criteria for unipolar, non-psychotic major depressive disorder. Participants must be at low suicide risk, and be able to complete study procedures.

Participants will complete screening, informed consent, clinical assessments, pregnancy safety review, and high-density EEG recordings. Eligible participants will attend one in-person stimulation visit and will be randomized to receive PandA-tACS, individualized alpha-frequency tACS, or sham stimulation. Stimulation will be delivered through scalp electrodes while participants are monitored by trained study staff. EEG, symptom ratings, blood pressure, pre-natal safety checks, and adverse event monitoring will be completed before and/or after stimulation. Optional MRI may be completed for electric-field modeling. Pregnancy and birth outcomes will be reviewed through the medical record.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Inactive Sham (placebo)
Participants will receive sham tACS. Sham stimulation mimics all procedures used in active stimulation.
Other: Sham (placebo) tACS
Participants will be fitted with the same electrode setup and receive sham (placebo) tACS delivered using the neuroConn DC Stimulator MC.
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.
Other: IAF-tACS
Participants will be fitted with the same electrode setup and receive IAF-tACS delivered using the neuroConn DC Stimulator MC.
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.
Other: PandA-tACS
Participants will be fitted with the same electrode setup and receive PandA-tACS delivered using the neuroConn DC Stimulator MC.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety via the presence of any serious AEs
Time Frame: Day 1 to within 90 days of expected delivery date.
The number of serious adverse events (SAEs) deemed at least potentially related to PandA-tACS.
Day 1 to within 90 days of expected delivery date.
Tolerability of PandA-tACS
Time Frame: Immediately after intervention
Proportion of participants reporting stimulation intolerance or unable to complete stimulation due to tolerability.
Immediately after intervention
Feasibility of PandA-tACS
Time Frame: Through completion of the study, roughly 2 years
Total number of enrolled participants. Must be at least 45 overall, and 15 per group.
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).
Pre- to post-stimulation change in left dorsolateral prefrontal cortex (dlPFC) aperiodic slope (beta coefficient/exponent) derived from resting high-density (HD-EEG). The endpoint will be compared for PandA-tACS versus IAF-tACS and sham.
Immediately before and after 40 minutes of stimulation (on single interventional session day).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation between modeled left dorsolateral prefrontal cortex (dlPFC) electric field strength and pre- to post-stimulation change in left dlPFC aperiodic slope
Time Frame: Immediately before and after 40 minutes of stimulation (on single interventional session day).
Within the PandA-tACS group, correlation between modeled left dlPFC electric field strength and pre- to post-stimulation change in left dlPFC aperiodic slope.
Immediately before and after 40 minutes of stimulation (on single interventional session day).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Flavio Frohlich, PhD, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 26-1564
  • R61MH144538 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

This study will collect 128-channel high-density electroencephalography (HD-EEG) data, clinician and self-report assessments relating to depression and other mood symptoms, diagnostic interviews relating to psychiatric disorders, medical chart information including current and past medical history in relation to general medical history, pregnancy and birth outcome information, and psychiatric history; anatomical MRI data, intervention experience questionnaires including tolerability and blinding questionnaires, demographic data, blood pressure at each intervention visit, and daily self-reported prenatal symptoms. The investigators will share de-identified HD-EEG, MRI, safety, feasibility, and tolerability data, symptom ratings, intervention experience questionnaires, demographic data, blood pressure and pre-natal symptoms. Data will be available on the NIMH Data Archive (NDA) per NIMH policies, and also the Open Science Framework (open source) labelled under the appropriate NCT number.

IPD Sharing Time Frame

Research participant data (e.g., demographics [age, sex], symptom ratings [DSM-5 Cross Cutting Symptom Measure, WHODAS, GAD-7, PHQ-9], blood pressure, pre-natal symptoms, intervention experience questionnaires, safety, feasibility, and tolerability data) on a 6-month schedule starting one year after receipt of award as required by the NDA. MRI imaging data, and raw and pre-processed electroencephalography data will be shared upon completion of the award. Code created as part of this award will be uploaded to GitHub upon relevant publication. The NIMH NDA has standard processes in place for the request of data use and will arbitrate which requests to allow. The scientific data will be made available for at least as long as required by applicable data repository policies.

IPD Sharing Access Criteria

Data will be findable and identifiable through the NDA Collection associated with this award. NDA collections have digital object identifiers (DOIs), making them easy to locate. The investigators will upload a data dictionary alongside relevant data. Code created as part of this award will be uploaded to GitHub upon relevant publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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