Skip to main content
OpenTrials
Completed

NCT Number: NCT06034496

Cranial Electrotherapy Stimulation and Acute Stress

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anxiety State Anxiety Disorders Mental Disorders

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts University

Medford, Massachusetts, 02155, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Active CES

Device

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.

Other names: Alpha-Stim

Sham CES

Device

Sham CES group will be identical to Active CES group with the exception of the device not administering any electrical current

Other names: Alpha-Stim

Primary outcomes

  1. Change From Baseline in Heart Rate During Stressful Lethal Force Decision Making Task

    Time frame: Baseline and follow-up session after 20 CES to be completed within 4-6weeks

    heart rate will be measured in beats per minute.

  2. Change From Baseline in Respiration Rate During Stressful Lethal Force Decision Making Task

    Time frame: Baseline and follow-up session after 20 CES to be completed within 4-6weeks

    respiration rate will be measured in breaths per minute.

  3. Change From Baseline in Heart Rate Variability During Stressful Lethal Force Decision Making Task

    Time frame: Baseline and follow-up session after 20 CES to be completed within 4-6weeks

    Heart rate variability will be measured in RMSSD.

  4. Change Over Time in Cortisol During Stressful Lethal Force Decision Making Task

    Time frame: 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.

  5. Change Over Time in Alpha Amylase During Stressful Lethal Force Decision Making Task

    Time frame: 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.

  6. Change Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-up

    Time frame: 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.

  7. Change From Baseline in Recognition Memory

    Time frame: 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.

  8. Change From Baseline in Spatial Orientation

    Time frame: 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.

  9. Change From Baseline in Decision Making Accuracy

    Time frame: 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.

  10. Change From Baseline in Decision Making Reaction Time

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

Cranial Electrotherapy Stimulation (CES) Influences on Acute Stress Responses

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 13, 2023
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.