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Pain Management Using Mobile Technology in Veterans With PTSD and TBI

CompletedNot applicableNCT02237885
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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…

Study details

Official title
Pain Management Using Mobile Technology in Veterans With PTSD and TBI
Conditions
Interventions
  • Device: NeuroSky MindWave Mobile
Sponsor
Duke University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Start date
2015-08-01
Primary completion
2017-11-21
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02237885