NCT04838925

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: CrossComm, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Pain
• Opioid Use

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-22
• Primary completion: 2023-09-01
• Completion: 2024-04-01
• First posted: 2021-04-09
• Last updated: 2023-08-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study