N/A N=58 Randomized Triple-blind Basic Science

Cranial Electrotherapy Stimulation and Acute Stress

Anxiety State

Bottom Line

View on ClinicalTrials.gov: NCT06034496 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2025

Primary outcome: Primary: Change From Baseline in Heart Rate During Stressful Lethal Force Decision Making Task — 98.5; 111; 100.0; 114 bpm — p=.012

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Active CES (Device); Sham CES (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Tufts University
Primary completion: Nov 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Heart Rate During Stressful Lethal Force Decision Making Task	98.5; 111; 100.0; 114	.012 sig
PRIMARY Change From Baseline in Respiration Rate During Stressful Lethal Force Decision Making Task	16.2; 17.7; 17.3; 16.8	.6
PRIMARY Change From Baseline in Heart Rate Variability During Stressful Lethal Force Decision Making Task	13.0; 11.2; 12.0; 10.5	.26
PRIMARY Change Over Time in Cortisol During Stressful Lethal Force Decision Making Task	.293; .415; .54; .399; .57; .655	.18
PRIMARY Change Over Time in Alpha Amylase During Stressful Lethal Force Decision Making Task	118; 79.1; 144; 131; 88.6; 84	.10
PRIMARY Change Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-up	33.71; 29.52; 33.33; 32.64; 33.4; 31.0	.23
PRIMARY Change From Baseline in Recognition Memory	77.1; 80; 78.2; 76.7	.85
PRIMARY Change From Baseline in Spatial Orientation	20.7; 18.8; 21.2; 16.3	.13
PRIMARY Change From Baseline in Decision Making Accuracy	3.64; 3.89; 4.48; 4.75	.36
PRIMARY Change From Baseline in Decision Making Reaction Time	—	—

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.

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06034496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.