Cranial Electrotherapy Stimulation and Acute Stress

NCT ID: NCT06034496

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-12
• Study Completion Date: 2024-11-14

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.

Conditions

Anxiety State

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Active CES

Active Cranial Electrotherapy Stimulation (CES)

Group Type: ACTIVE_COMPARATOR

Active CES

Intervention Type: 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.

Sham CES

Sham Cranial Electrotherapy Stimulation (CES)

Group Type: SHAM_COMPARATOR

Sham CES

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Sham CES

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

Intervention Type: DEVICE

Other Intervention Names

Alpha-Stim; Alpha-Stim

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:

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kana Okano, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Tufts University

Locations

Tufts University

Medford, Massachusetts, United States

Countries

United States

References

Okano K, Lee MM, Hart-Pomerantz H, Smith M, Sandone MK, Harvey T, Brunye TT. Effects of repeated cranial electrotherapy stimulation on physiological and behavioral responses to acute stress: a double-blind randomized clinical trial. Front Hum Neurosci. 2025 Aug 13;19:1641801. doi: 10.3389/fnhum.2025.1641801. eCollection 2025.

Reference Type: DERIVED

PMID: 40881935 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STUDY00003572

Identifier Type: -

Identifier Source: org_study_id