The purpose of this pilot trial is to primarily assess safety, feasibility, and tolerability of PandA-tACS in antenatal depression and determine whether a single PandA-tACS session produces greater left dlPFC aperiodic slope flattening (reduction) from pre- to post-stimulation than IAF-tACS and sham.
Aged 18 - 45
Capacity to understand all relevant risks and potential benefits of the study as determined by study staff (provision of informed consent) Stated willingness to comply with all study procedures and availability for the duration of the study
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.
Between weeks 14-32 of viable singleton pregnancy
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
Lifetime history of bipolar disorder, as evidenced by DIAMOND
Schizophrenia spectrum and other psychotic disorders, as evidenced by DIAMOND
Parallel
Sham (placebo) tACS
Other interventionParticipants will be fitted with the same electrode setup and receive sham (placebo) tACS delivered using the neuroConn DC Stimulator MC.
IAF-tACS
Other interventionParticipants will be fitted with the same electrode setup and receive IAF-tACS delivered using the neuroConn DC Stimulator MC.
PandA-tACS
Other interventionParticipants will be fitted with the same electrode setup and receive PandA-tACS delivered using the neuroConn DC Stimulator MC.
Safety via the presence of any serious AEs
The number of serious adverse events (SAEs) deemed at least potentially related to PandA-tACS.
Tolerability of PandA-tACS
Proportion of participants reporting stimulation intolerance or unable to complete stimulation due to tolerability.
Feasibility of PandA-tACS
Total number of enrolled participants. Must be at least 45 overall, and 15 per group.
Change in aperiodic slope in the dlPFC region.
Pre- to post-stimulation change in left dorsolateral prefrontal cortex (dlPFC) aperiodic slope (beta coefficient/exponent) derived from resting high-density (HD-EEG). The endpoint will be compared for PandA-tACS versus IAF-tACS and sham.
Correlation between modeled left dorsolateral prefrontal cortex (dlPFC) electric field strength and pre- to post-stimulation change in left dlPFC aperiodic slope
Within the PandA-tACS group, correlation between modeled left dlPFC electric field strength and pre- to post-stimulation change in left dlPFC aperiodic slope.
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University of North Carolina, Chapel Hill
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
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