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Trial record 97 of 157 for:    (Dementia pugilistica OR chronic traumatic encephalopathy) AND Injuries

Pain Management Using Mobile Technology in Veterans With PTSD and TBI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02237885
Recruitment Status : Completed
First Posted : September 11, 2014
Last Update Posted : December 4, 2017
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Duke University

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

Condition or disease Intervention/treatment Phase
Chronic Pain Posttraumatic Stress Disorders Traumatic Brain Injury Device: NeuroSky MindWave Mobile Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Pain Management Using Mobile Technology in Veterans With PTSD and TBI
Actual Study Start Date : August 1, 2015
Actual Primary Completion Date : November 21, 2017
Actual Study Completion Date : November 21, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Neurofeedback Device: NeuroSky MindWave Mobile
Other Names:
  • Mobile Neurofeedback (Application)
  • Apple iPod touch

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in participant's self-reported pain score from 0-10, 0 least amount of pain, 10 highest [ Time Frame: Baseline, 3 months ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02237885

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United States, North Carolina
Duke University, Department of Psychiatry
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
National Center for Complementary and Integrative Health (NCCIH)
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Principal Investigator: Eric Elbogen, PhD Duke University, Dept. of Psychiatry

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Responsible Party: Duke University Identifier: NCT02237885     History of Changes
Other Study ID Numbers: Pro00068864
R34AT008399-01 ( U.S. NIH Grant/Contract )
14-1138 ( Other Identifier: University of North Carolina - Chapel Hill )
Pro00068864 ( Other Identifier: Duke University Health System IRB )
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Duke University:
Military Veterans
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Chronic Pain
Stress Disorders, Post-Traumatic
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders