Transcranial Alternating Current Stimulation for Prenatal Depression

(PandA-tACS Trial)

Overseen By Zachary Stewart

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Psychotropics, Neurostimulation

Disqualifiers: Bipolar, Schizophrenia, Diabetes, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 1 week

10 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Flavio Frohlich, PhD, MSc ETH, MA

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

This trial is for pregnant individuals experiencing antenatal depression. Participants should be in good general health and not currently receiving other treatments for depression.

Inclusion Criteria

I am a woman aged between 18 and 45.

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.

I have been using effective birth control for at least a month and agree to continue during the study.

Exclusion Criteria

History of autism spectrum disorder

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive five consecutive days of personalized transcranial alternating current stimulation (tACS)

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including virtual follow-up and birth outcomes review

19 days for virtual follow-up, up to 90 days for birth outcomes review

1 visit (virtual)

Treatment Details

Interventions

• Personalized Aperiodic Transcranial Alternating Current Stimulation

Trial Overview The study is testing a personalized brain stimulation technique called transcranial alternating current stimulation (tACS) to see if it's safe and can help with depression during pregnancy.

Participant Groups

Group I: Healthy Control Group Experimental Treatment 1 Intervention

Aperiodic tACS delivered using a waveform based on individual participant EEG activity which has been modified to alter excitation/inhibition balance.

Group II: Antenatal Depression Group Experimental Treatment 1 Intervention

Aperiodic tACS delivered using a waveform based on individual participant EEG activity which has been modified to alter excitation/inhibition balance.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Brain & Behavior Research Foundation

Collaborator

Trials

63

Recruited

2,900+

Michigan State University

Collaborator

Trials

202

Recruited

687,000+