An interventional study of Mobile Neurofeedback App in Chronic Pain and Opioid Use, sponsored by CrossComm, Inc.. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-24.
Sponsored by CrossComm, Inc. · Not applicable, Interventional, and Device feasibility
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.
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.
2,930 studies on the registry are indexed under Chronic Pain; 699 are open to participants now.
This study's enrollment of 23 is below the median of 60 across 2,160 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →This is the only study on the registry with CrossComm, Inc. as lead sponsor.
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Exclusion Criteria:
Participants engage in the use of a mobile neurofeedback intervention, which involves using a mobile app paired with an EEG headset, to achieve a calm, relaxed state. Participants will be instructed to use the intervention at a minimum of 10 minutes a day, 4 times a week for a total of 12 weeks.
Device: Mobile Neurofeedback App
Neurofeedback intervention delivered via mobile app. Participants wear an EEG headset which is connected to a mobile app that delivers feedback about brainwave data indicating whether they are in a calm, relaxed state. Participants hear a lower/simple sound when they are below a target level and higher/richer sound when they approach or achieve their target.
Mobile App Usage
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.
Time frame: 12 weeks
Mobile App Satisfaction assessed on a 5-point Likert scale (1: very dissatisfied - 5: very satisfied)
Rating on a 5-point Likert scale (1: very dissatisfied - 5: very satisfied) of how satisfied participants were with the mobile neurofeedback app.
Time frame: At 3 month follow-up (end of intervention)
Mobile App Usability assessed by the System Usability Scale
The participant indicates level of agreement with 10 statements (1: strongly disagree - 5 strongly agree). Scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. (From: https://www.usability.gov/how-to-and-tools/methods/system-usability-scale.html) Higher scores indicate better usability.
Time frame: At 3 month follow-up (end of intervention)
Plan to share: No
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This study is active, not recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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