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

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ClinicalTrials.gov Identifier: NCT04838925
Recruitment Status : Recruiting
First Posted : April 9, 2021
Last Update Posted : July 20, 2022
Sponsor:
Collaborators:
Duke University
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
CrossComm, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Pain Opioid Use Device: Mobile Neurofeedback App Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Using Mobile Devices for Neurofeedback to Reduce Opioid Use in Chronic Pain
Actual Study Start Date : June 22, 2022
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Mobile App Usage [ Time Frame: 12 weeks ]
    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.


Secondary Outcome Measures :
  1. Mobile App Satisfaction assessed on a 5-point Likert scale (1: very dissatisfied - 5: very satisfied) [ Time Frame: At 3 month follow-up (end of intervention) ]
    Rating on a 5-point Likert scale (1: very dissatisfied - 5: very satisfied) of how satisfied participants were with the mobile neurofeedback app.

  2. Mobile App Usability assessed by the System Usability Scale [ Time Frame: At 3 month follow-up (end of intervention) ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04838925


Contacts
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Contact: Eric B Elbogen, PhD 919-684-9983 eric.elbogen@duke.edu
Contact: Alex Thompson 919-681-1613 DBHTL@duke.edu

Locations
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United States, North Carolina
Duke University School of Medicine Department of Psychiatry Recruiting
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
CrossComm, Inc.
Duke University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Eric B Elbogen, PhD Duke University
Principal Investigator: Donald K Shin CrossComm, Inc.
More Information
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Responsible Party: CrossComm, Inc.
ClinicalTrials.gov Identifier: NCT04838925    
Other Study ID Numbers: Pro00106634
1R41DA053011-01 ( U.S. NIH Grant/Contract )
First Posted: April 9, 2021    Key Record Dates
Last Update Posted: July 20, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by CrossComm, Inc.:
Chronic Pain
Opioids
Prescription Opioids
Pain
Musculoskeletal Pain
Mobile Apps
 Mobile Health
Neurofeedback
EEG Feedback
Biofeedback
Alternative Therapy
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations