Recruiting

Nerve StimulationNon-invasive Nerve Stimulation for PTSD and Sleep

Sponsor:

University of Florida

Code:

NCT03170440

Conditions

Post Traumatic Stress Disorder

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Transcutaneous nerve stimulation location 1

Study Details

Brief summary:

In this study, our objective is to determine the effect of two different nerve stimulation types in changing sleep architecture.

Conditions

Post Traumatic Stress Disorder

Traumatic Brain Injury

Study ID

NCT03170440

Start date

Nov 1, 2017

Status verified date

Jun, 2025

Completion date

Oct 30, 2025

Anticipated

Primary completion date

Oct 30, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

veterans with history of PTSD with and without history of mild TBI

Exclusion Criteria with:

history of severe psychiatric illness unrelated to PTSD or TBI
other medical conditions of severity that may impair cognition
current illicit or prescription drug abuse
breathing disorder requiring constant use of oxygen

Study Design

Enrollment

221 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Noninvasive nerve stimulation type I

This group will receive one type of nerve stimulation

active comparator: Noninvasive nerve stimulation type II

This group will receive second type of nerve stimulation

Interventions

Transcutaneous nerve stimulation location 1

Non-invasive stimulation by transcutaneous electrical nerve stimulation device in test location

Primary outcome measure

Physiological sleep architectural quality [ Time Frame: up to 8 hours ]

Central Contacts and Locations

Central contacts

John Williamson, PhD

35523761611 john.williamson2@va.gov

Locations

UF Health Jacksonville

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Meghan Marotz, MS

904-244-9620 meghan.marotz@jax.ufl.edu

John Williamson, PhD

3523761611 john.williamson@ufl.edu

Principal Investigator:

John Williamson, Ph.D.

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

John Williamson, PhD

352-294-4903 john.williamson@ufl.edu

Principal Investigator:

John Williamson, Ph.D.

UF Health Jacksonville

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

Meghan Marotz, MS

904-244-9620 meghan.marotz@jax.ufl.edu

More Information

Sponsor

University of Florida

Last update posted

Jul 1, 2025

Last verified

Jun, 2025

Keywords

Nerve stimulation
sleep deprivation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2025-07-01.