NCT06034496

Cranial Electrotherapy Stimulation and Acute Stress

Cranial Electrotherapy Stimulation (CES) Influences on Acute Stress Responses

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Tufts University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Anxiety State

Interventions

Type	Name	Description
DEVICE	Active CES	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.
DEVICE	Sham CES	Sham CES group will be identical to Active CES group with the exception of the device not administering any electrical current

Timeline

• Start date: 2023-09-12
• Primary completion: 2024-11-14
• Completion: 2024-11-14
• First posted: 2023-09-13
• Last updated: 2025-09-15
• Results posted: 2025-06-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study