Pain Management Using Mobile Technology in Veterans With PTSD and TBI

NCT02237885 | Completed DMC

• 3 other identifiers: Pro00068864R34AT008399-0114-1138
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Pain; Posttraumatic Stress Disorders; Traumatic Brain Injury

Keywords

Military Veterans

Outcome Measures

Primary Outcomes (1)

• Number of ten minute neurofeedback sessions completed on mobile platform

  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.

  3 months

Secondary Outcomes (1)

• Change in participant's self-reported pain score from 0-10, 0 least amount of pain, 10 highest

  Baseline, 3 months

Study Arms (1)

Neurofeedback

EXPERIMENTAL

Device: NeuroSky MindWave Mobile

Interventions

NeuroSky MindWave Mobile DEVICE

Also known as: Mobile Neurofeedback (Application), Apple iPod touch

Neurofeedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Duke University, Department of Psychiatry

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• 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.

  PMID: 31697371 RESULT

MeSH Terms

Conditions

Chronic Pain; Stress Disorders, Post-Traumatic; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Eric Elbogen, PhD

  Duke University, Dept. of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: September 11, 2014
• Study Start: August 1, 2015
• Primary Completion: November 21, 2017
• Study Completion: November 21, 2017
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)