CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 76 enrolled
Drug / intervention
Active CES +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06034496
NCT06034496N/ACompleted

Cranial Electrotherapy Stimulation (CES) Influences on Acute Stress Responses

Tufts University·interventional·Posted Sep 13, 2023·Updated Sep 15, 2025

In Brief

A clinical study evaluating Active CES and Sham CES for Anxiety State. Completed, enrolled 76 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnxiety State
CountriesUnited States

Timeline

N/ACompletedFinished
202420252026
First PostedSep 13, 2023
Enrollment StartSep 12, 2023
Primary CompletionNov 14, 2024
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 2.8 years ago

Interventions

Active CESdevice

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.

Sham CESdevice

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