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临床试验/NCT04838925
NCT04838925进行中(未招募)不适用

Using Mobile Devices for Neurofeedback to Reduce Opioid Use in Chronic Pain

CrossComm, Inc.2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2022年6月22日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
23
试验地点
2
主要终点
Mobile App Usage

研究概览

简要总结

The purpose of this study is to develop and test the feasibility of a commercially-ready mobile neurofeedback app for individuals with chronic pain. Thirty (30) participants who are prescribed opioids for chronic pain will use the new mobile neurofeedback app and an EEG headset for 10 minutes at a time, 4 times a week for 12 weeks and provide feedback about using the app.

详细描述

In this STTR Phase I project, CrossComm will collaborate with Duke University to develop a commercial-ready mobile neurofeedback technology and test its feasibility among patients using opioids to treat chronic pain. Specific Aim 1 is to develop a commercial-ready mobile neurofeedback app and will be built according to commercial standards of robustness and maintainability. Specific Aim 2 is to test feasibility of the commercially available mobile app in N=30 patients with chronic pain prescribed opioids. Participants will be recruited for a baseline interview with the Duke Behavioral Health & Technology Lab after passing a preliminary telephone screen. After providing informed consent, participants will provide data on demographics, pain symptoms, and opioid consumption. Each participant will download the mobile neurofeedback app to their smartphone and be instructed to use the intervention for 10 minutes a day, 4 times a week for 12 weeks. Study coordinators will conduct four teleconference sessions (weeks 1, 3, 6 and 9) to reinforce training, troubleshoot difficulties, and support intervention utilization. After the 12-week mobile neurofeedback intervention, the investigators will collect follow-up data, including pain measures, mobile app (usage, satisfaction, & usability), and user feedback on the human-computer interface. Data from these will inform further app refinement preparing for STTR Phase II.

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

  • Reports chronic pain (≥4 on 0-10 Numeric Rating Scale (NRS) on most days during the past 3 months)
  • Prescribed opioids for pain management

排除标准

  • History of seizures
  • Plans to have pain-related surgery in the next 3 months
  • Has an implanted medical device that could experience interference during EEG, such as a spinal cord stimulator or pacemaker

结局指标

主要结局

Mobile App Usage

时间窗: 12 weeks

Objective data on number of mobile neurofeedback sessions completed by participants. Intervention adherence data will inform the feasibility of real-world use of the commercial-ready mobile app.

次要结局

  • Mobile App Satisfaction assessed on a 5-point Likert scale (1: very dissatisfied - 5: very satisfied)(At 3 month follow-up (end of intervention))
  • Mobile App Usability assessed by the System Usability Scale(At 3 month follow-up (end of intervention))

研究者

发起方
CrossComm, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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