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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-22

Study Completion Date

2024-04-30

Brief Summary

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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.

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Detailed Description

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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

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Chronic Pain Opioid Use

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Mobile Neurofeedback

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.

Group Type EXPERIMENTAL

Mobile Neurofeedback App

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No