Clinical trial NCT02237885: Pain Management Using Mobile Technology in Veterans With PTSD and TBI
Official title: Pain Management Using Mobile Technology in Veterans With PTSD and TBI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Posttraumatic Stress Disorders
Traumatic Brain Injury
Keywords: Military Veterans
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2014-09-11
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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


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

Primary outcomes:
measure: Number of ten minute neurofeedback sessions completed on mobile platform
timeFrame: 3 months
Secondary outcomes:
measure: Change in participant's self-reported pain score from 0-10, 0 least amount of pain, 10 highest
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University, Department of Psychiatry
state: North Carolina
Study officials:
affiliation: Duke University, Dept. of Psychiatry
name: Eric Elbogen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elbogen EB, Alsobrooks A, Battles S, Molloy K, Dennis PA, Beckham JC, McLean SA, Keith JR, Russoniello C. Mobile Neurofeedback for Pain Management in Veterans with TBI and PTSD. Pain Med. 2021 Feb 23;22(2):329-337. doi: 10.1093/pm/pnz269.