Cranial Electrotherapy Stimulation (CES) Influences on Acute Stress Responses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Change From Baseline in Heart Rate During Stressful Lethal Force Decision Making Task
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Coded devices with master key kept outside of research team.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Use of prescription medications, other than oral contraceptives
- •Women only:
- •Pregnant or plan to become pregnant during the study
- •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.
- •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)
结局指标
主要结局
Change From Baseline in Heart Rate During Stressful Lethal Force Decision Making Task
时间窗: Baseline and follow-up session after 20 CES to be completed within 4-6weeks
heart rate will be measured in beats per minute.
Change From Baseline in Respiration Rate During Stressful Lethal Force Decision Making Task
时间窗: Baseline and follow-up session after 20 CES to be completed within 4-6weeks
respiration rate will be measured in breaths per minute.
Change From Baseline in Heart Rate Variability During Stressful Lethal Force Decision Making Task
时间窗: Baseline and follow-up session after 20 CES to be completed within 4-6weeks
Heart rate variability will be measured in RMSSD.
Change Over Time in Cortisol During Stressful Lethal Force Decision Making Task
时间窗: Baseline and follow-up session after 20 CES completed within 4-6weeks
Cortisol (µg/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.
Change Over Time in Alpha Amylase During Stressful Lethal Force Decision Making Task
时间窗: Baseline and follow-up session after 20 CES completed within 4-6weeks
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.
Change Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-up
时间窗: 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
STAI assesses both state and trait anxiety separately with each scale ranging from 20 to 80, with higher scores correlating with greater anxiety. STAI-S is the State Trait Anxiety Inventory - State version, and STAI-T is the State Trait Anxiety Inventory - Trait version.
Change From Baseline in Recognition Memory
时间窗: Baseline and follow-up session after 20 CES completed within 4-6weeks
Recognition memory of previously learned targets while ignoring visually similar distractor objects will be measured and evaluated with percent accuracy.
Change From Baseline in Spatial Orientation
时间窗: Baseline and follow-up session after 20 CES completed within 4-6weeks
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.
Change From Baseline in Decision Making Accuracy
时间窗: Baseline and follow-up session after 20 CES completed within 4-6weeks
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.
Change From Baseline in Decision Making Reaction Time
时间窗: Baseline and follow-up session after 20 CES completed within 4-6weeks
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.
次要结局
未报告次要终点