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临床试验/NCT02237885
NCT02237885已完成不适用

Pain Management Using Mobile Technology in Veterans With PTSD and TBI

Duke University2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2015年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
2
主要终点
Number of ten minute neurofeedback sessions completed on mobile platform

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Number of ten minute neurofeedback sessions completed on mobile platform

时间窗: 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.

次要结局

  • Change in participant's self-reported pain score from 0-10, 0 least amount of pain, 10 highest(Baseline, 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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