Cranial Electrotherapy Stimulation and Acute Stress

NCT06034496 | Completed Results FDA Device

• 1 other identifier: STUDY00003572
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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

Keywords

Cranial Electrotherapy Stimulation; Acute Stress

Outcome Measures

Primary Outcomes (10)

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

  heart rate will be measured in beats per minute.

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

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

  respiration rate will be measured in breaths per minute.

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

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

  Heart rate variability will be measured in RMSSD.

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

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

  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.

  Baseline and follow-up session after 20 CES completed within 4-6weeks

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

  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.

  Baseline and follow-up session after 20 CES completed within 4-6weeks

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

  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.

  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

• Change From Baseline in Recognition Memory

  Recognition memory of previously learned targets while ignoring visually similar distractor objects will be measured and evaluated with percent accuracy.

  Baseline and follow-up session after 20 CES completed within 4-6weeks

• Change From Baseline in Spatial Orientation

  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.

  Baseline and follow-up session after 20 CES completed within 4-6weeks

• Change From Baseline in Decision Making Accuracy

  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.

  Baseline and follow-up session after 20 CES completed within 4-6weeks

• Change From Baseline in Decision Making Reaction Time

  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.

  Baseline and follow-up session after 20 CES completed within 4-6weeks

Study Arms (2)

Active CES

ACTIVE COMPARATOR

Active Cranial Electrotherapy Stimulation (CES)

Device: Active CES

Sham CES

SHAM COMPARATOR

Sham Cranial Electrotherapy Stimulation (CES)

Device: Sham CES

Interventions

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.

Also known as: Alpha-Stim

Active CES

Sham CES DEVICE

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

Also known as: Alpha-Stim

Sham CES

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tufts University: lead
• United States Department of Defense: collaborator

Study Sites (1)

Tufts University

Medford, Massachusetts, 02155, United States

Location

Related Publications (1)

• 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.

  PMID: 40881935 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Research Assistant Professor
• Organization: Center for Applied Brain and Cognitive Sciences

kana.okano@tufts.edu

617-627-1059

Study Officials

• Kana Okano, Ph.D.

  Tufts University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Coded devices with master key kept outside of research team.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: September 13, 2023
• Study Start: September 12, 2023
• Primary Completion: November 14, 2024
• Study Completion: November 14, 2024
• Last Updated: September 15, 2025
• Results First Posted: June 17, 2025

Record last verified: 2025-09

Locations

US (1)