RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pilot Study Using Endogenous Aperiodic Brain Activity to Personalize Transcranial Alternating Current Stimulation as a Treatment for Antenatal Depression: PandA-tACS

Quick Facts

Study Start:2025-08

Study Completion:2026-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06979154

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.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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. * 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. * 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 ≥14	* 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 * 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 * Current pregnancy or lactation (as determined by urine pregnancy test) * History of depression, as evidenced by DIAMOND * 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

Inclusion Criteria

Exclusion 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.
* 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.
* 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 ≥14

* 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
* 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
* Current pregnancy or lactation (as determined by urine pregnancy test)
* History of depression, as evidenced by DIAMOND
* 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

Contacts and Locations

Study Contact

Athena Stein, PhD

CONTACT

19199669929

athena_stein@med.unc.edu

Zachary Stewart

CONTACT

9199669929

zachary_stewart@med.unc.edu

Principal Investigator

Flavio Frohlich, PhD, MSc ETH, MA

PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Study Locations (Sites)

Carolina Center for Neurostimulation

Chapel Hill, North Carolina, 27516

United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

Flavio Frohlich, PhD, MSc ETH, MA, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2025-08

Study Completion Date2026-12-01

Study Record Updates

Study Start Date2025-08

Study Completion Date2026-12-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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