Cranial Electrotherapy Stimulation and Acute Stress

Tufts University

Status: Completed

Conditions: Anxiety State

Treatments: Device: Sham CES; Device: Active CES

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06034496

STUDY00003572

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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76 participants in 2 patient groups

Active CES

Active Comparator group

Description:

Active Cranial Electrotherapy Stimulation (CES)

Treatment:

Device: Active CES

Sham CES

Sham Comparator group

Description:

Sham Cranial Electrotherapy Stimulation (CES)

Treatment:

Device: Sham CES