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

NCT04838925 | Unknown FDA Device

• 2 other identifiers: Pro001066341R41DA053011-01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Pain; Opioid Use

Keywords

Chronic Pain; Opioids; Prescription Opioids; Pain; Musculoskeletal Pain; Mobile Apps; Mobile Health; Neurofeedback; EEG Feedback; Biofeedback; Alternative Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (2)

• 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)

Study Arms (1)

Mobile Neurofeedback

EXPERIMENTAL

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

Interventions

Mobile Neurofeedback App 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.

Mobile Neurofeedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• CrossComm, Inc.: lead
• Duke University: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Duke University School of Medicine Department of Psychiatry

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Chronic Pain; Pain; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Eric B Elbogen, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• Donald K Shin

  CrossComm, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 9, 2021
• Study Start: June 22, 2022
• Primary Completion: September 1, 2023
• Study Completion: April 1, 2024
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)