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Clinical Trials/NCT02237885
NCT02237885
Completed
Not Applicable

Pain Management Using Mobile Technology in Veterans With PTSD and TBI

Duke University1 site in 1 country41 target enrollmentAugust 1, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Duke University
Enrollment
41
Locations
1
Primary Endpoint
Number of ten minute neurofeedback sessions completed on mobile platform
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Up to half of military veterans with traumatic brain injury (TBI) also suffer from co-occurring posttraumatic stress disorder (PTSD). Both are linked to higher risk of chronic pain, one of the most common health complaints among U.S. veterans who served in Operation Enduring Freedom (Afghanistan), Operation Iraqi Freedom (Iraq), and Operation New Dawn (OEF/OIF/OND). However, pain medications elevate risk of opioid abuse, and studies indicate that veterans perceive barriers to traditional mental health treatments. Little research exists regarding non-pharmacological, technology-based interventions designed to reduce pain in veterans with PTSD and TBI. Mobile technology used to implement neurofeedback (EEG biofeedback) shows promise in providing a portable, low-cost intervention for reducing pain in veterans with co-occurring disorders. We aim to test the feasibility and effectiveness of using mobile neurofeedback devices for reducing pain symptoms in veterans with PTSD and TBI. Veterans with PTSD, TBI, and chronic pain will receive a NeuroSky headset (which reads EEG brain waves) and an iPod Touch with an app called Mobile Neurofeedback (which provides neurofeedback to induce relaxation). Veterans are taught how to use these together to do neurofeedback themselves at home for 12 weeks. Guided by existing research and preliminary data, we hypothesize that participants will show high levels of adherence to the NeuroSky + Mobile Neurofeedback intervention for the 3-month study duration and that participants will show statistically significant reduction in pain symptoms at 3 months compared to baseline. Given links between pain and other outcomes in veterans, we will also explore effects on drug abuse, violence, and suicidality. When the research is complete, the field will be changed because we will know whether new technology reading EEG brainwaves can be used to treat symptoms among individuals suffering from chronic pain. We will also know whether neurofeedback shows promise as an effective intervention for veterans with PTSD and TBI to reduce pain and related outcomes. If this program of research is successful, its impact will be to shift approaches to managing pain in clinical practice, for both veterans and civilians

Registry
clinicaltrials.gov
Start Date
August 1, 2015
End Date
November 21, 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Military veteran who served during Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and/or Operation New Dawn (OND)
  • Posttraumatic Stress Disorder (PTSD)
  • Traumatic Brain Injury (TBI)
  • Chronic pain

Exclusion Criteria

  • History of epilepsy, seizure disorder, or have ever had a seizure or epileptic fit
  • Pregnancy or breastfeeding

Outcomes

Primary Outcomes

Number of ten minute neurofeedback sessions completed on mobile platform

Time Frame: 3 months

Per protocol, participants will be requested to complete 4 neurofeedback sessions per week for 12 weeks. This data will be collected on participants' mobile devices.

Secondary Outcomes

  • Change in participant's self-reported pain score from 0-10, 0 least amount of pain, 10 highest(Baseline, 3 months)

Study Sites (1)

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