NCT06979154

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The purpose of this study is an initial pilot study to develop the safety, feasibility, and tolerability of a novel, individualized transcranial alternating current stimulation (tACS) approach in antenatal depression, which delivers personalized stimulation waveforms based on the aperiodic component of individual participant EEG activity (PandA-tACS). In Phase I, five healthy controls will receive five consecutive days of PandA-tACS. High-density electroencephalography will be collected at Baseline, D1 and D5, as well as intermittently throughout stimulation sessions. Symptoms will be checked at FUP1 (two weeks following intervention). In Phase II, PandA-tACS will be expanded into five patients with antenatal depression with the same study design. In addition to HD-EEG measurements, depression and related symptoms will be measured at D1, D5 in these patients. Depression and related symptoms will be measured again FUP1 (two weeks following intervention) and FUP2 (4-6 weeks post delivery). Birth outcomes will be recorded within 90 days of expected delivery date as an additional form of safety monitoring. Primary Aim: To investigate the safety, feasibility, and tolerability of five days of PandA-tACS in healthy controls (Phase I) and in participants with antenatal depression (Phase II). Exploratory Aim: To investigate aperiodic EEG changes following five days of PandA-tACS in healthy controls and in participants with antenatal depression. Additionally, changes in depression symptoms will be investigated two weeks following PandA-tACS in antenatal depression.

Conditions

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

Interventions

Type	Name	Description
DEVICE	tACS (aperiodic)	Individualized tACS waveform based on aperiodic EEG activity will be delivered.

Timeline

• Start date: 2025-08-12
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-05-18
• Last updated: 2026-04-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study