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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04838925
• Other study ID #: Pro00106634
• Secondary ID: 1R41DA053011-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 22, 2022
• Est. completion date: April 2024

Study information

• Verified date: August 2023
• Source: CrossComm, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 23
• Est. completion date: April 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Opioid Use

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University School of Medicine Department of Psychiatry	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
CrossComm, Inc.	Duke University, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mobile App Satisfaction assessed on a 5-point Likert scale (1: very dissatisfied - 5: very satisfied)	Rating on a 5-point Likert scale (1: very dissatisfied - 5: very satisfied) of how satisfied participants were with the mobile neurofeedback app.	At 3 month follow-up (end of intervention)
Secondary	Mobile App Usability assessed by the System Usability Scale	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.	At 3 month follow-up (end of intervention)