Neuromodulatory Treatments for Pain Management in TBI

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Pain, Traumatic Brain Injury, Posttraumatic Stress Disorder

Intervention / Treatment
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* Device: Mindfulness
* Device: Neurofeedback
* Device: Relaxation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Served in one of the military branches (Army, Navy, Marines, Air Force, or Coast Guard) since October 2001. 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. 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: History of epilepsy, seizure disorder, or any seizure or epileptic fit. Unable to provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile App Mindfulness<br>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<br>* Neuromodulatory intervention for pain management<br>|
| Experimental: Mobile App Neurofeedback<br>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<br>* Neuromodulatory intervention for pain management<br>|
| Experimental: Mobile App Relaxation<br>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<br>* Neuromodulatory intervention for pain management<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Military Veterans