Antenatal DepressionPandA-tACSNCT06979154
Pilot Study of Personalized Aperiodic Transcranial Alternating Current Stimulation in Antenatal Depression (PandA-tACS)
A study testing tACS (aperiodic) in people with Antenatal Depression and Major Depressive Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Antenatal Depression, Major Depressive Disorder, Major Depressive Disorder in Pregnancy
- What is being tested?
- tACS (aperiodic)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2025to 29 Jun 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 Columbia Suicide Severity Rating Scale (C-SSRS) screen and triage version with further exploration of positive responses.
- For healthy control population:
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- 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 Diagnostic and Statistical Manual-5 (DSM-5) diagnosis of unipolar, non-psychotic Major depressive disorder (MDD) which is confirmed by the DIAMOND
- Hamilton Depression Rating Scale-17 (HDRS-17) score ≥8
Who cannot join
- 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
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- 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 Central nervous system (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
- Unstable medical disorder or anything that would place the participant at increased risk or preclude the participant's full compliance with or completion of the study, in the opinion of the Investigator
- Additional for the healthy control population:
- Current pregnancy or lactation (as determined by urine pregnancy test)
- History of depression, as evidenced by DIAMOND
- Additional for the antenatal depression population:
- 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 prenatal care
- No scheduled prenatal 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
- Other cause of markedly high-risk pregnancy as determined by the Investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolina Center for Neurostimulation
Chapel Hill, North Carolina, 27516
About this study
Official title: Pilot Study Using Endogenous Aperiodic Brain Activity to Personalize Transcranial Alternating Current Stimulation as a Treatment for Antenatal Depression: PandA-tACS
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.
Read the detailed description
The purpose of this study is an initial pilot study to develop the safety, feasibility, and tolerability of a novel, individualized transcranial alternating current stimulation (tACS) approach in antenatal depression, which delivers personalized stimulation waveforms based on the aperiodic component of individual participant EEG activity (PandA-tACS). In Phase I, five healthy controls will receive five consecutive days of PandA-tACS. High-density electroencephalography will be collected at Baseline, D1 and D5, as well as intermittently throughout stimulation sessions. Symptoms will be checked at Follow-up 1 (FUP1) (two weeks following intervention). In Phase II, PandA-tACS will be expanded into five patients with antenatal depression with the same study design. In addition to high density (HD) HD-EEG measurements, depression and related symptoms will be measured at D1, D5 in these patients. Depression and related symptoms will be measured again FUP1 (two weeks following intervention) and Follow-up 2 (FUP2) (4-6 weeks post delivery). Birth outcomes will be recorded within 90 days of expected delivery date as an additional form of safety monitoring.
Primary Aim: To investigate the safety, feasibility, and tolerability of five days of PandA-tACS in healthy controls (Phase I) and in participants with antenatal depression (Phase II).
Exploratory Aim: To investigate aperiodic EEG changes following five days of PandA-tACS in healthy controls and in participants with antenatal depression. Additionally, changes in depression symptoms will be investigated two weeks following PandA-tACS in antenatal depression.
- Conditions
- Antenatal Depression, Major Depressive Disorder, Major Depressive Disorder in Pregnancy, Healthy Controls
- Being tested
- tACS (aperiodic)
- 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
- Medical subject headings
- Depressive Disorder, Major, Behavioral Symptoms, Mood Disorders, Mental Disorders, Depression, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tACS (aperiodic)Device
Individualized tACS waveform based on aperiodic EEG activity will be delivered.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: tACS (aperiodic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Healthy controls: Day 1 through Follow-up 1 (Day 19). Antenatal depression participants: Day 1 through birth outcome assessment within 90 days after delivery, up to 17 weeks after Day 1.
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
Measured: Baseline to end of recruitment period (12 months following recruitment start)
Feasibility Via the Number of Participants Completing All Study Visits Within the Intervention Period
The number of participants who complete all study visits within the intervention period in the healthy control and antenatal depression groups.
Measured: Baseline (up to 7 days before intervention Day 1) to Day 5 (end of five-day intervention)
Tolerability Via the Number 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.
Measured: 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.
Measured: 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 .
Measured: Healthy controls: Day 1 through Follow-up 1 (Day 19). Antenatal depression participants: Day 1 through birth outcome assessment within 90 days after delivery, up to 17 weeks after Day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start12 Aug 2025
- Primary completion29 Jun 2026
- Study completion29 Jun 2026
Why it stopped: Due to lack of resources the study was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Antenatal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- First phase of study involves healthy controls. Second phase of study involves patients with antenatal depression.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Brain & Behavior Research Foundation, Michigan State University
- Responsible party
- Sponsor
- Investigators
- Flavio Frohlich, PhD, MSc ETH, MA, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979154
- Sponsor's protocol ID
- 25-0425
- Acronym
- PandA-tACS
- Status last verified
- Jun 2026
- First submitted
- 8 May 2025
- Last updated
- 28 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared in this study due to the small sample size, which may cause participants to become identifiable.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Using Endogenous Aperiodic Brain Activity to Personalize Transcranial Alternating Current Stimulation as a Treatment for Antenatal Depression: PandA-tACS
- ClinicalTrials.gov ID
- NCT06979154
- Acronym / sponsor ID
- PandA-tACS / 25-0425
- Conditions
- Antenatal Depression, Major Depressive Disorder, Major Depressive Disorder in Pregnancy, Healthy Controls
- Keywords
- Behavioral Symptoms, Mood Disorders, Mental Disorders, Depression, Depressive Disorder, Major Depressive Disorder, Antenatal diagnoses, Prenatal diagnoses
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to lack of resources the study was terminated.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Brain & Behavior Research Foundation, Michigan State University
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 29 Jun 2026 (actual)
- Study completion
- 29 Jun 2026 (actual)
- First posted
- 18 May 2025 (actual)
- Results
- Posted 28 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is an initial pilot study to develop the safety, feasibility, and tolerability of a novel, individualized transcranial alternating current stimulation (tACS) approach in antenatal depression, which delivers personalized stimulation waveforms based on the aperiodic component of individual participant EEG activity (PandA-tACS). In Phase I, five healthy controls will receive five consecutive days of PandA-tACS. High-density electroencephalography will be collected at Baseline, D1 and D5, as well as intermittently throughout stimulation sessions. Symptoms will be checked at Follow-up 1 (FUP1) (two weeks following intervention). In Phase II, PandA-tACS will be expanded into five patients with antenatal depression with the same study design. In addition to high density (HD) HD-EEG measurements, depression and related symptoms will be measured at D1, D5 in these patients. Depression and related symptoms will be measured again FUP1 (two weeks following intervention) and Follow-up 2 (FUP2) (4-6 weeks post delivery). Birth outcomes will be recorded within 90 days of expected delivery date as an additional form of safety monitoring.
Primary Aim: To investigate the safety, feasibility, and tolerability of five days of PandA-tACS in healthy controls (Phase I) and in participants with antenatal depression (Phase II).
Exploratory Aim: To investigate aperiodic EEG changes following five days of PandA-tACS in healthy controls and in participants with antenatal depression. Additionally, changes in depression symptoms will be investigated two weeks following PandA-tACS in antenatal depression.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- First phase of study involves healthy controls. Second phase of study involves patients with antenatal depression.
| Arm | Type | Receives |
|---|---|---|
| Healthy Control Group | Experimental | Device: tACS (aperiodic)Aperiodic tACS delivered using a waveform based on individual participant EEG activity which has been modified to alter excitation/inhibition balance. |
| Antenatal Depression Group | Experimental | Device: tACS (aperiodic)Aperiodic tACS delivered using a waveform based on individual participant EEG activity which has been modified to alter excitation/inhibition balance. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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 Columbia Suicide Severity Rating Scale (C-SSRS) screen and triage version with further exploration of positive responses.
Key exclusion criteria (57 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tACS (aperiodic)Individualized tACS waveform based on aperiodic EEG activity will be delivered. | Device | Antenatal Depression Group, Healthy Control Group |
Primary outcome
Safety Via the Presence of Any Serious AEs Related to Stimulation
Time frame: Healthy controls: Day 1 through Follow-up 1 (Day 19). Antenatal depression participants: Day 1 through birth outcome assessment within 90 days after delivery, up to 17 weeks after Day 1.
The number of serious adverse events reported in healthy control and antenatal depression groups.
Feasibility Via the Number of Participants Enrolled Relative to the Target Recruitment in Each Group
Time frame: Baseline to end of recruitment period (12 months following recruitment start)
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
Feasibility Via the Number of Participants Completing All Study Visits Within the Intervention Period
Time frame: Baseline (up to 7 days before intervention Day 1) to Day 5 (end of five-day intervention)
The number of participants who complete all study visits within the intervention period in the healthy control and antenatal depression groups.
Tolerability Via the Number of Participants Rating Stimulation-related Sensations as 'High'
Time frame: Day 1 to Day 5
The number of participants who rate stimulation-related sensations as 'high' within the intervention period in the healthy control and antenatal depression groups.
Tolerability Via the Proportion of Participants Reporting Intolerance to Stimulation
Time frame: Day 1 to Day 5
The proportion of participants who are unable to tolerate stimulation within the intervention period in the healthy control and antenatal depression groups.
Safety Via Review of Birth Outcomes Within 90 Days of Birth in the Antenatal Depression Population
Time frame: Healthy controls: Day 1 through Follow-up 1 (Day 19). Antenatal depression participants: Day 1 through birth outcome assessment within 90 days after delivery, up to 17 weeks after Day 1.
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 .
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NeuroConn DC-Stimulator MCLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared in this study due to the small sample size, which may cause participants to become identifiable.
Related trials for Antenatal Depression
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Stronger Together: Antenatal Depressive Symptoms - Prevalence and Digital Treatment
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Integration of Stepped Care for Perinatal Mood and Anxiety Disorders Among Women Attending MCH Clinics
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flavio Frohlich, PhD, MSc ETH, MA principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tACS (aperiodic) in people with Antenatal Depression and Major Depressive Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 57 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Via the Presence of Any Serious AEs Related to Stimulation (time frame: Healthy controls: Day 1 through Follow-up 1 (Day 19). Antenatal depression participants: Day 1 through birth outcome assessment within 90 days after delivery, up to 17 weeks after Day 1.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.