Cranial Electrotherapy Stimulation and Acute Stress

Study Overview
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Brief Summary
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The goal of this study is to quantify the effects of 20 sessions of Cranial Electrotherapy Stimulation (CES) on measures of acute stress responses in Soldiers. The main question it aims to answer is how 20 sessions of CES will affect Soldiers' biochemical (salivary alpha amylase and cortisol), physiological (e.g., heart rate, heart rate variability, respiration rate), emotional (state anxiety), and behavioral (i.e., cognitive task performance) responses. On Day 1, participants will complete a baseline measure assessing their biochemical, physiological, emotional, and behavioral responses to a stressful lethal force decision making task. In the next four to six weeks, participants will complete 20 CES sessions. Within five days of completing the 20 CES sessions, participants will complete a follow-up measure assessing their biochemical, physiological, emotional, and behavioral responses to the same stressful lethal force decision making task they completed on Day 1. Researchers will compare the Active CES group to the Sham CES group to see how 20 sessions of Active CES will affect the participants responses to their biochemical, physiological, emotional and behavioral responses relative to the Sham CES group.

Official Title
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Cranial Electrotherapy Stimulation (CES) Influences on Acute Stress Responses

Conditions
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Anxiety State

Intervention / Treatment
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* Device: Active CES
* Device: Sham CES


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-40 years of age (17-40 if emancipated minor) Can sit and stand freely. Have not used or experienced CES administration in the past. Agree to have their data stored in a repository (database) for future use. Exclusion Criteria: Use of prescription medications, other than oral contraceptives Women only: Pregnant or plan to become pregnant during the study Nursing History of: A neurological or psychological disorder (such as depression, anxiety disorders, migraines, cluster headaches, seizures, Post-traumatic stress disorder (PTSD) or panic attacks). Cardiac disease (including arrhythmia or fast or skipped heart beats). Implanted medical devices, such as pacemakers. Hypertension. Insomnia Head injury (including neurosurgery, concussion, TBI, skull fracture, hematoma) Illness that caused brain injury Any other brain-related condition (such as traumatic brain injury) Metal in the head (outside of mouth, such as shrapnel, surgical clips, or fragments from welding or metalwork) Implanted medical device (e.g., pacemaker, insulin pump)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active CES<br>Active Cranial Electrotherapy Stimulation (CES) | Device: Active CES<br>* Active CES group will receive a minimum of 250µA and up to 500µA depending on thresholding, once daily for 20 days (over the course of 4 6 weeks), 20 minutes per day.<br>* Other names: Alpha-Stim;|
| Sham Comparator: Sham CES<br>Sham Cranial Electrotherapy Stimulation (CES) | Device: Sham CES<br>* Sham CES group will be identical to Active CES group with the exception of the device not administering any electrical current<br>* Other names: Alpha-Stim;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in heart rate during stressful lethal force decision making task | heart rate will be measured in beats per minute. | Baseline and follow-up session after 20 CES to be completed within 4-6weeks | 
| Change from baseline in respiration rate during stressful lethal force decision making task | respiration rate will be measured in breaths per minute. | Baseline and follow-up session after 20 CES to be completed within 4-6weeks | 
| Change from baseline in heart rate variability during stressful lethal force decision making task | Heart rate variability will be measured in RMSSD. | Baseline and follow-up session after 20 CES to be completed within 4-6weeks | 
| Change over time in alpha amylase during stressful lethal force decision making task | Alpha amylase (IU) will be measured through saliva samples. Saliva samples will be taken at five time points, approximately 20 minute increments during the baseline and follow-up sessions. | Baseline and follow-up session after 20 CES completed within 4-6weeks | 
| Change over time in cortisol during stressful lethal force decision making task | Cortisol (ng/dL) will be measured through saliva samples. Saliva samples will be taken at five time points, approximately 20 minute increments during the baseline and follow-up sessions. | Baseline and follow-up session after 20 CES completed within 4-6weeks | 
| Change over time in State Trait Anxiety Inventory (STAI) scores at each session (including CES sessions) from baseline to follow-up | STAI assesses both state and trait anxiety separately with each scale ranging from 20 to 80, with higher scores correlating with greater anxiety. | At baseline, at each of the 20 CES sessions completed within 4-6weeks, and at follow-up to be completed within 5 days of last CES | 
| Change from baseline in recognition memory | Recognition memory of previously learned targets while ignoring visually similar distractor objects will be measured and evaluated with d prime scores. Higher d prime scores correlate with more accurate responses. | Baseline and follow-up session after 20 CES completed within 4-6weeks | 
| Change from baseline in spatial orientation | Spatial orientation task will involve pointing towards a series of distant (out of visible range) landmarks in the virtual environment and estimating distance to those landmarks. Spatial orientation will be calculated using mean absolute angular error. Larger numbers correlate with higher error. | Baseline and follow-up session after 20 CES completed within 4-6weeks | 
| Change from baseline in decision making accuracy | Participants will make lethal force decision making by shooting at threatening targets and allowing non-threatening targets to pass. Decision making accuracy will be calculated using d prime. Higher d prime correlates with better accuracy. | Baseline and follow-up session after 20 CES completed within 4-6weeks | 
| Change from baseline in decision making reaction time | Participants will make lethal force decision making by shooting at threatening targets and allowing non-threatening targets to pass. Decision making reaction time to shoot at threatening targets will be measured in milliseconds. | Baseline and follow-up session after 20 CES completed within 4-6weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cranial Electrotherapy Stimulation, Acute Stress