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Finding studies
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Lead
University of North Carolina, Chapel Hill
With
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 Follow-up 1 (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 high density (HD) 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 Follow-up 2 (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.
Age
18–45
Sex
FEMALE
Healthy volunteers
Accepted
