Antenatal DepressionPandANCT07799480
Single Session Personalized Aperiodic Transcranial Alternating Current Stimulation (PandA-tACS) for Antenatal Depression
A study testing IAF-tACS and PandA-tACS in people with Antenatal Depression, run by University of North Carolina, Chapel Hill.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Antenatal Depression
- What is being tested?
- IAF-tACS and PandA-tACS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 50Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Antenatal Depression
- Being tested
- Sham (placebo) tACS, IAF-tACS, PandA-tACS
- Keywords
- Non-invasive brain stimulation, tACS, Neurostimulation, Mood Disorders, Depression, Transcranial Alternating Current Stimulation, EEG, IAF-tACS, Individual Alpha Frequency tACS, Antenatal
- Medical subject headings
- Mood Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham (placebo) tACSOther
Participants will be fitted with the same electrode setup and receive sham (placebo) tACS delivered using the neuroConn DC Stimulator MC.
IAF-tACSOther
Participants will be fitted with the same electrode setup and receive IAF-tACS delivered using the neuroConn DC Stimulator MC.
PandA-tACSOther
Participants will be fitted with the same electrode setup and receive PandA-tACS delivered using the neuroConn DC Stimulator MC.
| Study group | Role | What they receive |
|---|---|---|
| Inactive Sham (placebo) | Sham comparator | Participants will receive sham tACS. Sham stimulation mimics all procedures used in active stimulation. Receives: Other: Sham (placebo) tACS |
| Active IAF-tACS: Experimental Arm | Active comparator | 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. Receives: Other: IAF-tACS |
| Active PandA-tACS: Experimental Arm | Experimental | 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. Receives: Other: PandA-tACS |
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
The number of serious adverse events (SAEs) deemed at least potentially related to PandA-tACS.
Measured: Day 1 to within 90 days of expected delivery date.
Tolerability of PandA-tACS
Proportion of participants reporting stimulation intolerance or unable to complete stimulation due to tolerability.
Measured: Immediately after intervention
Feasibility of PandA-tACS
Total number of enrolled participants. Must be at least 45 overall, and 15 per group.
Measured: Through completion of the study, roughly 2 years
Change in aperiodic slope in the dlPFC region.
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.
Measured: Immediately before and after 40 minutes of stimulation (on single interventional session day).
Secondary outcomes (1)
Correlation between modeled left dorsolateral prefrontal cortex (dlPFC) electric field strength and pre- to post-stimulation change in left dlPFC aperiodic slope
Within the PandA-tACS group, correlation between modeled left dlPFC electric field strength and pre- to post-stimulation change in left dlPFC aperiodic slope.
Measured: Immediately before and after 40 minutes of stimulation (on single interventional session day).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study design is a parallel arm design in which participants will be randomized 1:1:1 to receive PandA-tACS, IAF-tACS or sham (placebo)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Flavio Frohlich, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799480
- Sponsor's protocol ID
- 26-1564
- Other IDs
- R61MH144538
- Acronym
- PandA
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Session Personalized Aperiodic Transcranial Alternating Current Stimulation (PandA-tACS) for Antenatal Depression: A Randomized, Sham-Controlled Trial (R61 Phase)
- ClinicalTrials.gov ID
- NCT07799480
- Acronym / sponsor ID
- PandA / 26-1564
- Conditions
- Antenatal Depression
- Keywords
- Non-invasive brain stimulation, tACS, Neurostimulation, Mood Disorders, Depression, Transcranial Alternating Current Stimulation, EEG, IAF-tACS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
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 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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Study design is a parallel arm design in which participants will be randomized 1:1:1 to receive PandA-tACS, IAF-tACS or sham (placebo)
| Arm | Type | Receives |
|---|---|---|
| Inactive Sham (placebo) | Sham comparator | Other: Sham (placebo) tACSParticipants will receive sham tACS. Sham stimulation mimics all procedures used in active stimulation. |
| Active IAF-tACS: Experimental Arm | Active comparator | Other: IAF-tACSParticipants 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. |
| Active PandA-tACS: Experimental Arm | Experimental | Other: PandA-tACSParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (50 listed)
- 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
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 |
|---|---|---|
| Sham (placebo) tACSParticipants will be fitted with the same electrode setup and receive sham (placebo) tACS delivered using the neuroConn DC Stimulator MC. | Other | Inactive Sham (placebo) |
| IAF-tACSParticipants will be fitted with the same electrode setup and receive IAF-tACS delivered using the neuroConn DC Stimulator MC. | Other | Active IAF-tACS: Experimental Arm |
| PandA-tACSParticipants will be fitted with the same electrode setup and receive PandA-tACS delivered using the neuroConn DC Stimulator MC. | Other | Active PandA-tACS: Experimental Arm |
Primary outcome
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.
Tolerability of PandA-tACS
Time frame: Immediately after intervention
Proportion of participants reporting stimulation intolerance or unable to complete stimulation due to tolerability.
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.
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.
1 secondary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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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.
Flavio Frohlich, PhD principal investigator
University of North Carolina, Chapel Hill
Questions about this trial
What is this clinical trial studying?
A study testing IAF-tACS and PandA-tACS in people with Antenatal Depression, run by University of North Carolina, Chapel Hill.
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 6 inclusion and 50 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: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Flavio Frohlich, PhD (919-966-9929, flavio_frohlich@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety via the presence of any serious AEs (time frame: Day 1 to within 90 days of expected delivery date.). The study lists 4 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 2 Sep 2026.