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
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|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain Opioid Use||Device: Mobile Neurofeedback App||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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|
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.
- 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.
- 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.
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Reports chronic pain (≥4 on 0-10 Numeric Rating Scale (NRS) on most days during the past 3 months)
- Prescribed opioids for pain management
- 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
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
|Contact: Eric B Elbogen, PhDemail@example.com|
|Contact: Alex Thompson||919-681-1613||DBHTL@duke.edu|
|United States, North Carolina|
|Duke University School of Medicine Department of Psychiatry||Recruiting|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Eric B Elbogen, PhD||Duke University|
|Principal Investigator:||Donald K Shin||CrossComm, Inc.|
|Responsible Party:||CrossComm, Inc.|
|Other Study ID Numbers:||
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|
|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|