Non-invasive Nerve Stimulation for PTSD and Sleep

NCT03170440 | Recruiting FDA Device

• 3 other identifiers: IRB201700541i01 rx003140-01aI01RX003140-01
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 3

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

Keywords

Nerve stimulation; sleep deprivation

Outcome Measures

Primary Outcomes (1)

• Physiological sleep architectural quality

  Polysomnography

  up to 8 hours

Study Arms (2)

Noninvasive nerve stimulation type I

EXPERIMENTAL

This group will receive one type of nerve stimulation

Device: Transcutaneous nerve stimulation location 1

Noninvasive nerve stimulation type II

ACTIVE COMPARATOR

This group will receive second type of nerve stimulation

Device: Transcutaneous nerve stimulation location 1

Interventions

Transcutaneous nerve stimulation location 1 DEVICE

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

Noninvasive nerve stimulation type I; Noninvasive nerve stimulation type II

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• US Department of Veterans Affairs: collaborator
• North Florida/South Georgia Veterans Health System: collaborator

Study Sites (3)

UF Health Jacksonville

Gainesville, Florida, 32608, United States

RECRUITING

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

UF Health Jacksonville

Jacksonville, Florida, 32209, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Brain Injuries, Traumatic; Sleep Deprivation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John Williamson, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Williamson, PhD

CONTACT

35523761611; john.williamson2@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 31, 2017
• Study Start: November 1, 2017
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)