Status:
COMPLETED
Cranial Electrotherapy Stimulation and Acute Stress
Lead Sponsor:
Tufts University
Collaborating Sponsors:
United States Department of Defense
Conditions:
Anxiety State
Eligibility:
All Genders
18-40 years
Phase:
NA
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 h...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2024
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT06034496
Start Date
September 12 2023
End Date
November 14 2024
Last Update
September 15 2025
Active Locations (1)
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1
Tufts University
Medford, Massachusetts, United States, 02155