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Non-invasive Nerve Stimulation

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ClinicalTrials.gov Identifier: NCT03170440
Recruitment Status : Recruiting
First Posted : May 31, 2017
Last Update Posted : July 18, 2019
Sponsor:
Collaborators:
VA Brain Rehabilitation Research Center
US Department of Veterans Affairs
Information provided by (Responsible Party):
University of Florida

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

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Traumatic Brain Injury Other: Transcutaneous nerve stimulation location 1 Other: Transcutaneous nerve stimulation location 2 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Non-invasive Vagal Nerve Stimulation and Sleep
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : August 15, 2020
Estimated Study Completion Date : December 15, 2020

Arm Intervention/treatment
Experimental: Noninvasive nerve stimulation type I
This group will receive one type of nerve stimulation
Other: Transcutaneous nerve stimulation location 1
Non-invasive stimulation by transcutaneous electrical nerve stimulation device in test location

Other: Transcutaneous nerve stimulation location 2
Stimulation will be performed using electrodes placed in alternate location.

Active Comparator: Noninvasive nerve stimulation type II
This group will receive second type of nerve stimulation
Other: Transcutaneous nerve stimulation location 1
Non-invasive stimulation by transcutaneous electrical nerve stimulation device in test location

Other: Transcutaneous nerve stimulation location 2
Stimulation will be performed using electrodes placed in alternate location.




Primary Outcome Measures :
  1. Physiological sleep architectural quality [ Time Frame: up to 8 hours ]
    Polysomnography



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria with:

  • history of severe psychiatric illness unrelated to PTSD
  • other medical conditions of severity that may impair cognition
  • current illicit or prescription drug abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03170440


Contacts
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Contact: Aidan J Murphy, B.A. 352 548 6000 ext 3329 aidanjmurphy@phhp.ufl.edu

Locations
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United States, Florida
North Florida/South Georgia Veterans Health System Recruiting
Gainesville, Florida, United States, 32608
Principal Investigator: John Williamson, Ph.D.         
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Aidan J Murphy, B.A.    352-548-6000 ext 3329    aidanjmurphy@phhp.ufl.edu   
Principal Investigator: John Williamson, Ph.D.         
Sub-Investigator: Damon Lamb, Ph.D.         
Sub-Investigator: Eric Porges, Ph.D.         
Sub-Investigator: Michael Jaffe, M.D.         
Sponsors and Collaborators
University of Florida
VA Brain Rehabilitation Research Center
US Department of Veterans Affairs
Investigators
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Principal Investigator: John Williamson, Ph.D. University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03170440     History of Changes
Other Study ID Numbers: IRB201700541
i01 rx003140-01a ( Other Grant/Funding Number: Department of Veterans Affairs )
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Nerve stimulation

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Trauma and Stressor Related Disorders
Mental Disorders