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| Name | Class |
|---|---|
| Brain & Behavior Research Foundation | OTHER |
| Michigan State University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Control Group | Experimental | Aperiodic tACS delivered using a waveform based on individual participant EEG activity which has been modified to alter excitation/inhibition balance. |
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| Antenatal Depression Group | Experimental | Aperiodic tACS delivered using a waveform based on individual participant EEG activity which has been modified to alter excitation/inhibition balance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tACS (aperiodic) | Device | Individualized tACS waveform based on aperiodic EEG activity will be delivered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety via the presence of any serious AEs related to stimulation | The number of serious adverse events reported in healthy control and antenatal depression groups. | Day 1 to Follow-Up (Day 19) (HC) or Day 1 to end of monitoring (birth outcomes review within 90 days of expected delivery date) (antenatal depression) |
| Feasibility via the number of participants enrolled relative to the target recruitment in each group | The number of participants enrolled relative to the target recruitment of five participants in each of the healthy control and antenatal depression groups over the specified 12-month period | Baseline to end of recruitment period (12 months following recruitment start) |
| Feasibility via the number of participants completing all study visits within the intervention and follow-up period | The number of participants who complete all study visits within the intervention and follow-up period in the healthy control and antenatal depression groups. | Healthy controls: Baseline to Follow-Up (Day 19); antenatal depression group: Baseline to Day 5 |
| Tolerability via the proportion of participants rating stimulation-related sensations as 'high' | The number of participants who rate stimulation-related sensations as 'high' within the intervention period in the healthy control and antenatal depression groups. | Day 1 to Day 5 |
| Tolerability via the proportion of participants reporting intolerance to stimulation | The proportion of participants who are unable to tolerate stimulation within the intervention period in the healthy control and antenatal depression groups. | Day 1 to Day 5 |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in aperiodic exponent following the five-day PandA-tACS intervention | The change in aperiodic exponent from resting state EEG recordings on the first day and the final day of stimulation in healthy control and antenatal depression populations. | Day 1 to Day 5 |
| Change in HDRS-17 score following intervention in the antenatal depression population |
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
For healthy control population:
Additional for antenatal depression population:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
Additional for the healthy control population:
Additional for the antenatal depression population:
History of any of the following conditions:
Current pregnancy:
Other cause of markedly high-risk pregnancy as determined by the Investigator
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| Name | Affiliation | Role |
|---|---|---|
| Flavio Frohlich, PhD, MSc ETH, MA | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolina Center for Neurostimulation | Chapel Hill | North Carolina | 27516 | United States |
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| Label | URL |
|---|---|
| NeuroConn DC-Stimulator MC | View source |
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Individual participant data will not be shared in this study due to the small sample size, which may cause participants to become identifiable.
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First phase of study involves healthy controls. Second phase of study involves patients with antenatal depression.
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| Safety via review of birth outcomes within 90 days of birth in the antenatal depression population |
The number of adverse birth outcomes in participants with antenatal depression. Review will consider length of pregnancy in days, delivery (spontaneous, induced, cesarian (planned or acute), vaginal birth, forceps and/or vacuum extraction), gestational age at birth, Apgar 5 min, malformation, child weight at birth in grams, birth size (small for gestational age, appropriate for gestational age, large for gestational age), neonatal need for intensive care, stillbirth, maternal length of stay in hospital, maternal need for intensive care, pre-eclampsia, as well as EPDS score between 2-4 weeks post-delivery . |
| Baseline to end of monitoring (birth outcomes review within 90 days of expected delivery date) |
The HDRS-17 is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 52. A higher score indicates a worse outcome. Investigators will determine the change in scores across the intervention from Day 1 to Day 5, Day 1 to Follow-up 1, Day 5 to Follow-up 1 |
| Day 1 up to Follow-up 1 (2 weeks post-stimulation) |
| Change in Edinburgh Postnatal Depression Scale (EPDS) in the antenatal depression population | The EPDS is a self-administered questionnaire designed to screen for potential symptoms of depression during pregnancy and the postpartum period. This scale consists of 10 short statements, where the participant checks off one of four possible answers about how they have been feeling for the past week. Responses are scored from 0-3, where total scores above 12 or 13 are likely to be suffering from depression. Investigators will determine the change in scores between across the intervention from Day 1 to Day 5, Day 1 to Follow-up 1, Day 5 to Follow-up 1. | Day 1 up to Follow-up 1 (2 weeks post-stimulation) |
| Change in Snaith-Hamilton Pleasure Scale (SHAPS) in the antenatal depression population | The SHAPS is a 14-item scale which assesses for anhedonia (the inability to experience pleasure) where each item has a set of four response categories (definitely agree=1, agree=2, disagree=3, definitely disagree=4). Participants are considered to be experiencing mild anhedonia if they disagree with three or more statements. Participants can agree or disagree on a minimum of 0 and maximum of 14 statements. Investigators will determine the change in scores across the intervention from Day 1 to Day 5, Day 1 to Follow-up 1, Day 5 to Follow-up 1. | Day 1 up to Follow-up 1 (2 weeks post-stimulation) |
| Change in Clinical Global Impression Scale (CGI) in the antenatal depression population | The CGI is a measure of symptom severity, treatment response and the efficacy of treatments. The CGI involves a single question for the clinician, who rates how mentally ill the participant is, on a scale from 1 (normal), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill) and 7 (among the most extremely ill participants). Investigators will determine the change in scores across the intervention from Day 1 to Day 5, Day 1 to Follow-up 1, Day 5 to Follow-up 1. | Day 1 up to Follow-up 1 (2 weeks post-stimulation) |
| Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) in the antenatal depression population | The Q-LES-Q-SF is a self-report measure of enjoyment and satisfaction in daily functioning. The total score ranges from 14 to 70, and is expressed as a percentage of the maximum total score that is achievable, where a percentage score ranging from 70-100 is generally indicative of a normal population. Investigators will determine the change in scores across the intervention by comparing scores from Day 1 to Day 5, Day 1 to Follow-up 1, Day 5 to Follow-up 1. | Day 1 up to Follow-up 1 (2 weeks post-stimulation) |
| Change in HDRS-17 score following intervention in the antenatal depression population (postnatal period) | The HDRS-17 is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 52. A higher score indicates a worse outcome. Investigators will determine the change in scores across the intervention from Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery) | Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery) |
| Change in Edinburgh Postnatal Depression Scale (EPDS) in the antenatal depression population (postnatal period) | The EPDS is a self-administered questionnaire designed to screen for potential symptoms of depression during pregnancy and the postpartum period. This scale consists of 10 short statements, where the participant checks off one of four possible answers about how they have been feeling for the past week. Responses are scored from 0-3, where total scores above 12 or 13 are likely to be suffering from depression. Investigators will determine the change in scores between Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery) | Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery) |
| Change in Snaith-Hamilton Pleasure Scale (SHAPS) in the antenatal depression population (postnatal period) | The SHAPS is a 14-item scale which assesses for anhedonia (the inability to experience pleasure) where each item has a set of four response categories (definitely agree=1, agree=2, disagree=3, definitely disagree=4). Participants are considered to be experiencing mild anhedonia if they disagree with three or more statements. Participants can agree or disagree on a minimum of 0 and maximum of 14 statements. Investigators will determine the change in scores across the intervention from Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery) | Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery) |
| Change in Clinical Global Impression Scale (CGI) in the antenatal depression population (postnatal period) | The CGI is a measure of symptom severity, treatment response and the efficacy of treatments. The CGI involves a single question for the clinician, who rates how mentally ill the participant is, on a scale from 1 (normal), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill) and 7 (among the most extremely ill participants). Investigators will determine the change in scores across the intervention from Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery) | Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery) |
| Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) in the antenatal depression population (postnatal period) | The Q-LES-Q-SF is a self-report measure of enjoyment and satisfaction in daily functioning. The total score ranges from 14 to 70, and is expressed as a percentage of the maximum total score that is achievable, where a percentage score ranging from 70-100 is generally indicative of a normal population. Investigators will determine the change in scores across the intervention by comparing scores from Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery) | Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery) |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D001526 | Behavioral Symptoms |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D003863 | Depression |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D001519 | Behavior |
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