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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 is a NA study that has completed, run by Duke University. The registered enrollment target is 41 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02237885
The ClinicalTrials.gov registry entry for NCT02237885 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which NeuroSky MindWave Mobile is the first listed.
NCT02237885 reports 0 study locations.
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.
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