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NCT02237885 · ClinicalTrials.gov registry record · NA
Pain Management Using Mobile Technology in Veterans With PTSD and TBI
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 41
- Enrollment target
NCT02237885: Completed NA study, sponsored by Duke University.
NCT02237885 is a NA study that has completed, run by Duke University. The registered enrollment target is 41 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02237885, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 41 participants
- Enrollment target
Study 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
Primary Outcome
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.
Interventions
- DEVICE NeuroSky MindWave Mobile
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2015-08-01 |
| Est. Completion | 2017-11-21 |
| Phase | NA |
What the finished NCT02237885 record still lists
NCT02237885 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which NeuroSky MindWave Mobile is the first listed.
NCT02237885 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02237885 about?
NCT02237885 is a clinical study titled "Pain Management Using Mobile Technology in Veterans With PTSD and TBI". 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), O...
What is the current status of trial NCT02237885?
This trial is currently completed. It is a NA study. The enrollment target is 41 participants. The study started on 2015-08-01. Estimated completion is 2017-11-21.
What interventions are being tested in trial NCT02237885?
The interventions under investigation include: NeuroSky MindWave Mobile (DEVICE).
Who is sponsoring clinical trial NCT02237885?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02237885's enrollment target sits among peer trials
41 1446th of 2000 higher than 554 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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