Cranial Electrotherapy Stimulation and Acute Stress

Anxiety State Clinical Trial

Official title:

Cranial Electrotherapy Stimulation (CES) Influences on Acute Stress Responses

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06034496
• Other study ID #: STUDY00003572
• Status: Recruiting
• Phase: N/A
• Start date: September 12, 2023
• Est. completion date: July 2025

Study information

• Verified date: November 2023
• Source: Tufts University
• Contact: Kana Okano, Ph.D.
• Phone: (617) 627-1059
• Email: kana.okano[@]tufts.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety State

Intervention

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

Locations

Country	Name	City	State
United States	Tufts University	Medford	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts University	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change over time in cortisol during stressful lethal force decision making task	Cortisol (ng/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
Primary	Change over time in State Trait Anxiety Inventory (STAI) scores at each session (including CES sessions) 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.	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
Primary	Change from baseline in recognition memory	Recognition memory of previously learned targets while ignoring visually similar distractor objects will be measured and evaluated with d prime scores. Higher d prime scores correlate with more accurate responses.	Baseline and follow-up session after 20 CES completed within 4-6weeks
Primary	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
Primary	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
Primary	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