Working… Menu

Neuromodulatory Treatments for Pain Management in TBI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03418129
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : October 16, 2018
United States Department of Defense
Information provided by (Responsible Party):
Duke University

Brief Summary:
Traumatic brain injury (TBI) and chronic pain are common and serious health problems for military veterans and often co-occur, leading to poor post-deployment adjustment. Pharmacological treatments for pain elevate risk of opioid abuse, and research suggests veterans perceive barriers to existing non-pharmacological, clinic-based treatments. Thus, there is an urgent need to develop pain management approaches that are effective, overcome barriers to care, and are readily usable by Veterans. Evidence suggests that neuromodulatory treatments, grounded in understanding of neurophysiological mechanisms of pain, reduce pain-related symptoms and have the potential to be developed into self-directed treatments through use of mobile technology.

Condition or disease Intervention/treatment Phase
Chronic Pain Traumatic Brain Injury Posttraumatic Stress Disorder Device: Mindfulness Device: Neurofeedback Device: Relaxation Not Applicable

Detailed Description:
This study is a prospective, three-arm, randomized controlled trial of neuromodulatory treatments for chronic pain, for post-9/11 veterans with co-occuring pain and TBI. Three hundred participants will be scheduled for a baseline interview at the Duke Behavioral Health and Technology Lab after passing a preliminary telephone screen. After providing informed consent, participants will provide data on clinical measures. Electroencephalography (EEG) will be used to measure brain activity. Following data collection, participants will be assigned to one of three groups (n=100 in each). Each group will receive an iPod Touch with a different mobile application (app), which participants will be instructed to use for 10 minute a day, 4 times a week for 12 weeks. Study coordinators will conduct two home visits (week 1 and week 6) and two phone calls (week 3 and week 9) to reinforce training, troubleshoot difficulties, and ask about intervention utilization. Follow-up data on clinical measures and EEG will be collected at 12 weeks and again at 24 weeks.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neuromodulatory Treatments for Pain Management in Veterans With Complex TBI Using Mobile Technology
Actual Study Start Date : September 5, 2018
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Mobile App Mindfulness
Participants engage in the use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Device: Mindfulness
Neromodulatory intervention for pain management

Experimental: Mobile App Neurofeedback
Participants engage in use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Device: Neurofeedback
Neuromodulatory intervention for pain management

Experimental: Mobile App Relaxation
Participants engage in use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Device: Relaxation
Neuromodulatory intervention for pain management

Primary Outcome Measures :
  1. Change in self-reported pain intensity [ Time Frame: At 0 and 12 weeks ]
    Measured by the Defense and Veterans Pain Rating Scale (DVPRS), a graphic tool to facilitate self-reported pain rating using a scale from 0-10, 0 being "no pain" to 10 being "as bad as it could be, nothing else matters."

Secondary Outcome Measures :
  1. Change in EEG alpha power [ Time Frame: At 0 and 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Served in one of the military branches (Army, Navy, Marines, Air Force, or Coast Guard) since October 2001.
  2. Diagnosis of Traumatic Brain Injury (TBI), defined as a traumatically induced structural injury or physiological disruption of brain function, as a result of an external force, that is indicated by new or onset or worsening of at least one of the following signs immediately following the event:

    • Any alteration in mental status (e.g. confusion, disorientation, slowed thinking, etc.)
    • Any loss of memory for events immediately before or after the injury.
    • Any period of loss or a decreased level of consciousness, observed or self-reported.
  3. Reports chronic musculoskeletal and/or neuropathic pain, defined as moderate or severe pain (≥ 4 on a 0-10 rating scale) in one or more body regions for the previous 3 months or more. For individuals on pain medication, inclusion criteria are that (a) their pain medication regimen has been stable for the past 4 weeks, (b) they do not expect any major changes in their pain medication regimen for the duration of the study, and (c) they do not expect to have surgery or to be hospitalized for pain treatment for the duration of the study.

Exclusion Criteria:

  1. History of epilepsy, seizure disorder, or any seizure or epileptic fit.
  2. Women who report being pregnant or breastfeeding, report plans to become pregnant or begin breastfeeding in the next six months, or who have a positive result on a urine pregnancy test administered at the baseline interview.
  3. Unable to provide informed consent.

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 identifier (NCT number): NCT03418129

Layout table for location contacts
Contact: Eric Elbogen, PhD 919-684-9983
Contact: Sara Battles, M.Ed. 919-681-1613

Layout table for location information
United States, North Carolina
Duke University Medical Center, Department of Psychiatry Recruiting
Durham, North Carolina, United States, 27705
Contact: Sara Battles, MEd    919-681-1613   
Principal Investigator: Eric Elbogen, PhD         
Sponsors and Collaborators
Duke University
United States Department of Defense
Layout table for investigator information
Principal Investigator: Eric Elbogen, PhD Duke University

Layout table for additonal information
Responsible Party: Duke University Identifier: NCT03418129     History of Changes
Other Study ID Numbers: Pro00088360
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Per FITBIR policy on Data Sharing, we will submit all de-identified data to FITBIR after the completion of the study. All data are submitted in accord with applicable laws and regulations, and that the identities of research participants will not be disclosed to the FITBIR Informatics System. FITBIR Data Sharing Policy includes steps to protect the interests and privacy concerns of individuals, families, and identifiable groups who participate in TBI genetic and other research.
Time Frame: A contribution will be submitted after study completion and will remain in the FITBIR database indefinitely.
Access Criteria: Only individuals with a FITBIR account who have submitted a Data Access Request that has been reviewed by the Data Access Quality Committee will be able to view the data.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Duke University:
Military Veterans
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Chronic Pain
Stress Disorders, Post-Traumatic
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders