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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate a new treatment called transcranial alternating current stimulation (tACS) for women experiencing depression during pregnancy. It seeks to determine if this non-invasive brain stimulation is safe and effective in easing symptoms of antenatal depression. The trial includes both pregnant women with confirmed depression and healthy women as a control group. Participants may qualify if they are between 14 to 32 weeks pregnant, have been diagnosed with depression during pregnancy, and are receiving prenatal care. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on a novel treatment approach.

Do I have to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot have started any new psychotropic medications or changed doses in the 6 weeks before screening.

What prior data suggests that this personalized transcranial alternating current stimulation is safe for antenatal depression?

Research is exploring a new treatment called personalized aperiodic transcranial alternating current stimulation (tACS) for antenatal depression. Researchers are testing this treatment to determine its safety and comfort for users. Although detailed results are not yet available, ongoing studies focus on ensuring participants' safety and comfort.

As this is a new method, researchers closely monitor for any side effects. Any common or serious side effects would be a key focus of the research. The goal is to ensure the treatment is safe and manageable for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about personalized aperiodic transcranial alternating current stimulation (tACS) for prenatal depression because it offers a novel approach by using electrical stimulation tailored to an individual's brain activity. Unlike traditional treatments like antidepressants or psychotherapy, which can take weeks to show effects, tACS has the potential to impact brain function more directly and rapidly. This technique modifies the brain's excitation and inhibition balance, which might lead to quicker and more effective relief from depression symptoms without the side effects often associated with medications. Additionally, it provides a non-invasive alternative, making it particularly appealing for pregnant individuals who may have concerns about medication use.

What evidence suggests that this personalized tACS is effective for prenatal depression?

Research has shown that transcranial alternating current stimulation (tACS) can influence brain activity by adjusting the balance between excitatory and calming brain signals. In individuals with depression, this balance is often disrupted, so altering it might improve mood. Early studies suggest that a personalized version of tACS, tailored to individual brain patterns, could help treat depression. This trial will specifically explore its use for prenatal depression, with participants divided into a Healthy Control Group and an Antenatal Depression Group. Although specific data on its use for depression during pregnancy is limited, this method has shown promise for other types of depression. More research is needed, but the theory and early results are encouraging. ^{1 2 3 4 6}

Who Is on the Research Team?

Flavio Frohlich, PhD, MSc ETH, MA

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06979154

NCT06979154 | Pilot Study of Personalized Aperiodic ... The purpose of this study is to develop the safety, feasibility, and tolerability of a personalized transcranial alternating current stimulation (tACS) approach ...

2. trialx.com trialx.com/clinical-trials/listings/306329/pilot-study-of-personalized-aperiodic-transcranial-alternating-current-stimulation-in-antenatal-depression-panda-tacs/

Pilot Study of Personalized Aperiodic Transcranial ... The purpose of this study is to develop the safety, feasibility, and tolerability of a personalized transcranial alternating current stimulation ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06979154/pilot-study-of-personalized-aperiodic-transcranial-alternating-current-stimulation-in-antenatal-depression-panda-tacs?activelyRecruiting=false&page=16&id=7&slug=affective-disorders

Pilot Study of Personalized Aperiodic Transcranial ... The purpose of this study is to develop the safety, feasibility, and tolerability of a personalized transcranial alternating current stimulation ...

4. withpower.com withpower.com/trial/transcranial-alternating-current-stimulation-for-prenatal-depression-970ff

Transcranial Alternating Current Stimulation for Prenatal ... The purpose of this study is to develop the safety, feasibility, and tolerability of a personalized transcranial alternating current stimulation (tACS) approach ...

5. trial.medpath.com trial.medpath.com/clinical-trial/44d2d9ec31dbd5dd/nct06979154-brain-activity-tacs-antenatal-depression

Pilot Study of Personalized Aperiodic Transcranial Alternating ... The purpose of this study is to develop the safety, feasibility, and tolerability of a personalized transcranial alternating current stimulation (tACS) approach ...

6. researchforme.unc.edu researchforme.unc.edu/study-details?rcid=6638

Pilot study using personalized transcranial alternating ... The purpose of this study is an initial pilot study to develop the safety, feasibility, and tolerability of a new type of individualized transcranial ...