Neuromodulatory Treatments for Pain Management in TBI

Neuromodulatory Treatments for Pain Management in Veterans With Complex TBI Using Mobile Technology

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Traumatic Brain Injury; Posttraumatic Stress Disorder
• Intervention / Treatment: Device: Neurofeedback; Device: Relaxation; Device: Mindfulness

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.

• Study Type: Interventional
• Enrollment (Actual): 254
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center, Department of Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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. Unable to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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; Neuromodulatory 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Self-reported Pain Intensity	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."	Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in EEG Alpha Power	Average FFT (Fast Fourier Transform) Power (alpha 8-12 Hz) measured as sqrt(uV)/Hz.	0 and 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Self-reported Pain Intensity	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." This mean difference represents the mean change in pain intensity between 0 and 24 weeks. Please note that the analysis of results utilized a multilevel modeling (MLM) approach of all available data, which involved analyzing pain intensity data collected at 0, 12, and 24 weeks.	Baseline and 24 weeks

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Eric Elbogen, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2018
• Primary Completion (Actual): May 26, 2022
• Study Completion (Actual): August 26, 2022

Study Registration Dates

• First Submitted: November 3, 2017
• First Submitted That Met QC Criteria: January 31, 2018
• First Posted (Actual): February 1, 2018

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Military Veterans
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Chronic Pain; Brain Injuries; Stress Disorders, Post-Traumatic; Brain Injuries, Traumatic
• Other Study ID Numbers: Pro00088360

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Per FITBIR (Federal Interagency Traumatic Brain Injury Research) 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.
• IPD Sharing Time Frame: A contribution will be submitted after study completion and will remain in the FITBIR database indefinitely.
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No