Clinical trial NCT06034496: Cranial Electrotherapy Stimulation and Acute Stress
Official title: Cranial Electrotherapy Stimulation (CES) Influences on Acute Stress Responses
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anxiety State
Keywords: Cranial Electrotherapy Stimulation
Acute Stress
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2023-09-13
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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)

Primary outcomes:
measure: Change From Baseline in Heart Rate During Stressful Lethal Force Decision Making Task
timeFrame: Baseline and follow-up session after 20 CES to be completed within 4-6weeks
measure: Change From Baseline in Respiration Rate During Stressful Lethal Force Decision Making Task
timeFrame: Baseline and follow-up session after 20 CES to be completed within 4-6weeks
measure: Change From Baseline in Heart Rate Variability During Stressful Lethal Force Decision Making Task
timeFrame: Baseline and follow-up session after 20 CES to be completed within 4-6weeks
measure: Change Over Time in Cortisol During Stressful Lethal Force Decision Making Task
timeFrame: Baseline and follow-up session after 20 CES completed within 4-6weeks
measure: Change Over Time in Alpha Amylase During Stressful Lethal Force Decision Making Task
timeFrame: Baseline and follow-up session after 20 CES completed within 4-6weeks
measure: Change Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-up
timeFrame: 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
measure: Change From Baseline in Recognition Memory
timeFrame: Baseline and follow-up session after 20 CES completed within 4-6weeks
measure: Change From Baseline in Spatial Orientation
timeFrame: Baseline and follow-up session after 20 CES completed within 4-6weeks
measure: Change From Baseline in Decision Making Accuracy
timeFrame: Baseline and follow-up session after 20 CES completed within 4-6weeks
measure: Change From Baseline in Decision Making Reaction Time
timeFrame: Baseline and follow-up session after 20 CES completed within 4-6weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Medford
country: United States
facility: Tufts University
state: Massachusetts
Study officials:
affiliation: Tufts University
name: Kana Okano, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: