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Pain Management Using Mobile Technology in Veterans With PTSD and TBI

Primary Purpose

Chronic Pain, Posttraumatic Stress Disorders, Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NeuroSky MindWave Mobile
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Chronic Pain focused on measuring Military Veterans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University, Department of Psychiatry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neurofeedback

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in participant's self-reported pain score from 0-10, 0 least amount of pain, 10 highest
Per protocol, participants are enrolled if they have chronic pain defined as self-reporting on the numeric rating scale a score of 4 or above lasting three months or more. The study will therefore ask participants to self report their level of pain (from 0-10, 0 least amount of pain, 10 being the most) following the three months of the neurofeedback sessions.

Full Information

First Posted
September 9, 2014
Last Updated
January 14, 2020
Sponsor
Duke University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT02237885
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2015 (Actual)
Primary Completion Date
November 21, 2017 (Actual)
Study Completion Date
November 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Posttraumatic Stress Disorders, Traumatic Brain Injury
Keywords
Military Veterans

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurofeedback
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
NeuroSky MindWave Mobile
Other Intervention Name(s)
Mobile Neurofeedback (Application), Apple iPod touch
Primary Outcome Measure Information:
Title
Number of ten minute neurofeedback sessions completed on mobile platform
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in participant's self-reported pain score from 0-10, 0 least amount of pain, 10 highest
Description
Per protocol, participants are enrolled if they have chronic pain defined as self-reporting on the numeric rating scale a score of 4 or above lasting three months or more. The study will therefore ask participants to self report their level of pain (from 0-10, 0 least amount of pain, 10 being the most) following the three months of the neurofeedback sessions.
Time Frame
Baseline, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Elbogen, PhD
Organizational Affiliation
Duke University, Dept. of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University, Department of Psychiatry
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31697371
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.
Results Reference
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Pain Management Using Mobile Technology in Veterans With PTSD and TBI

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