Single Session Personalized Aperiodic Transcranial Alternating Current Stimulation (PandA-tACS) for Antenatal Depression
Single Session Personalized Aperiodic Transcranial Alternating Current Stimulation (PandA-tACS) for Antenatal Depression: A Randomized, Sham-Controlled Trial (R61 Phase)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 45 Years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: MRI scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Optional MRI may be completed for electric-field modeling."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
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 sites (1)
NC
- Carolina Center for Neurostimulation, Department of Psychiatry, UNC-Chapel Hill · Chapel Hill, NC 27516Athena Stein, PhD, MPH · Study contact · 919 966 9929 · ASTER@med.unc.eduHaileigh Taylor, BA · Study contact · 919 966 9929 · ASTER@med.unc.eduMore trials in Chapel Hill