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Pilot study using personalized transcranial alternating current stimulation as a treatment for antenatal depression: PandA-tACS (antenatal depression phase)

The purpose of this study is an initial pilot study to develop the safety, feasibility, and tolerability of a new type of individualized transcranial alternating current stimulation (tACS) to treat antenatal depression, which delivers personalized stimulation waveforms based individual participant EEG activity. In the previous stage of the study, we investigated this intervention in healthy controls. In the current phase of this study, we are investigating this intervention in people with antenatal depression (depression during pregnancy).

Age & Gender

  • 18 years ~ 45 years
  • Female

Visit Availability

  • Standard business hours (M-F, 8-5)
  • Extended hours (M-F, early morning or evening)
  • Weekend hours, if needed

Location

North Carolina (Statewide)

What will be asked of you

1. You will first complete a brief online pre-screening. If eligible, we will request a HIPAA authorization to review your medical records to confirm eligibility. 2. If you are determined to be eligible, we will schedule you for a remote screening appointment with a study staff member (about 1 hour). If you qualify, we will collect electronic informed consent at the conclusion of this screening session. 3. Within 30 days after the screening appointment, you will attend the Carolina Center for Neurostimulation to have high density electroencephalography (HD-EEG) to measure your brain activity (approximately 1.5 hour session). 4. The following week, you will return for five consecutive days of PandA-tACS, scheduled flexibly around your availability on Monday through Friday. Sessions will take approximately 3 hours on Monday and Friday, and 2-2.5 hours from Tuesday to Thursday. During the in-person visits, you will receive active PandA-tACS for 40 minutes. PandA-tACS uses a weak electrical current applied to your forehead through electrodes attached with paste. You will also answer questions about depression, mood symptoms and mental health. 5. Two weeks after your last session, you will have a 45 minute virtual follow-up to complete questionnaires about your mood and overall mental health. 6. 4-6 weeks after your delivery, you will have a final 45 minute virtual follow-up to complete questionnaires about your mood and overall mental health.

Incentives

Up to $600. Participants who attend screen and are ineligible will be reimbursed $20 for their time.

In-person visits:
6
Phone or online visits:
3
Total length of participation:
9 visits over 15-33 weeks (depending on gestational age at intervention)

Looking for Specific Volunteers

Able to participate:

  • Female aged 18-45
  • Between 14-32 weeks of pregnancy (single baby) at time of intervention
  • Received diagnosis of major depressive disorder
  • Current moderate - severe depressive symptoms

Not eligible if:

  • History of bipolar disorder, schizophrenia, and/or other psychotic disorders
  • Diagnosis of autism spectrum disorder
  • History of seizures (excluding febrile seizures in childhood)
  • Diagnosis of moderate - severe alcohol or substance use disorder in last 12 months
  • Prior brain surgery and/or brain implants

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Visit Study Website

Primary Visit Location

Carolina Center for Neurostimulation
100 Market Street, Chapel Hill, NC, USA

Additional Study Information

Principal Investigator

Flavio Frohlich
Psychiatry - Research

Study Type

Clinical or Medical
Interventional

Study Topics

Behavior
Brain, Head, Nervous System
Healthy Volunteer or General Population
Mental and Emotional Health
Parents of Children
Pregnancy
Women's Health
UNC or UNC Health employees
UNC Students (undergrad, grad, professional)

IRB Number

25-0425

ClinicalTrials.gov

NCT06979154

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