Cranial Electrotherapy Stimulation and Acute Stress

Not Applicable

Recruiting

• Conditions: Anxiety State
• Interventions: Device: Sham CES; Device: Active CES

• Registration Number: NCT06034496
• Lead Sponsor: Tufts University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-18
• Study First Submitted QC: 2023-09-05
• Study Start: 2023-09-12
• Study First Posted: 2023-09-13
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

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Exclusion Criteria

• Use of prescription medications, other than oral contraceptives

• Women only:

  1. Pregnant or plan to become pregnant during the study
  2. Nursing

• History of:

  1. A neurological or psychological disorder (such as depression, anxiety disorders, migraines, cluster headaches, seizures, Post-traumatic stress disorder (PTSD) or panic attacks).
  2. Cardiac disease (including arrhythmia or fast or skipped heart beats).
  3. Implanted medical devices, such as pacemakers.
  4. Hypertension.
  5. Insomnia
  6. Head injury (including neurosurgery, concussion, TBI, skull fracture, hematoma)
  7. Illness that caused brain injury
  8. Any other brain-related condition (such as traumatic brain injury)
  9. Metal in the head (outside of mouth, such as shrapnel, surgical clips, or fragments from welding or metalwork)
  10. Implanted medical device (e.g., pacemaker, insulin pump)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham CES	Sham CES	Sham Cranial Electrotherapy Stimulation (CES)
Active CES	Active CES	Active Cranial Electrotherapy Stimulation (CES)

Primary Outcome Measures

Name	Time	Method
Change from baseline in heart rate variability during stressful lethal force decision making task	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 State Trait Anxiety Inventory (STAI) scores at each session (including CES sessions) from baseline to follow-up	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.
Change from baseline in recognition memory	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 d prime scores. Higher d prime scores correlate with more accurate responses.
Change from baseline in respiration rate during stressful lethal force decision making task	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 spatial orientation	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 over time in alpha amylase during stressful lethal force decision making task	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 from baseline in decision making accuracy	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 heart rate during stressful lethal force decision making task	Baseline and follow-up session after 20 CES to be completed within 4-6weeks	heart rate will be measured in beats per minute.
Change over time in cortisol during stressful lethal force decision making task	Baseline and follow-up session after 20 CES completed within 4-6weeks	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.
Change from baseline in decision making reaction time	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.

Trial Locations

Locations (1)

Tufts University; 🇺🇸 Medford, Massachusetts, United States