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

NCT04838925 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2023-08-24

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Duke University

    collaborator OTHER

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • CrossComm, Inc.

    lead INDUSTRY

Principal Investigators

  • Eric B Elbogen, PhD · Duke University

  • Donald K Shin · CrossComm, Inc.

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-22
Primary Completion
2023-09-30
Completion
2024-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04838925 on ClinicalTrials.gov