Clinical trial NCT04838925: Using Mobile Devices for Neurofeedback to Reduce Opioid Use in Chronic Pain
Official title: Using Mobile Devices for Neurofeedback to Reduce Opioid Use in Chronic Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Pain
Opioid Use
Keywords: Chronic Pain
Opioids
Prescription Opioids
Pain
Musculoskeletal Pain
Mobile Apps
Mobile Health
Neurofeedback
EEG Feedback
Biofeedback
Alternative Therapy
Lead sponsor: CrossComm, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Duke University
name: National Institute on Drug Abuse (NIDA)
First posted: 2021-04-09
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Eligibility 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

Primary outcomes:
measure: Mobile App Usage
timeFrame: 12 weeks
Secondary outcomes:
measure: Mobile App Satisfaction assessed on a 5-point Likert scale (1: very dissatisfied - 5: very satisfied)
timeFrame: At 3 month follow-up (end of intervention)
measure: Mobile App Usability assessed by the System Usability Scale
timeFrame: At 3 month follow-up (end of intervention)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University School of Medicine Department of Psychiatry
state: North Carolina
Study officials:
affiliation: Duke University
name: Eric B Elbogen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CrossComm, Inc.
name: Donald K Shin
role: PRINCIPAL_INVESTIGATOR
References: