Chronic PainNCT04838925
Using Mobile Devices for Neurofeedback to Reduce Opioid Use in Chronic Pain
A study testing Mobile Neurofeedback App in people with Chronic Pain and Opioid Use, run by CrossComm, Inc. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Opioid Use
- What is being tested?
- Mobile Neurofeedback App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2022to Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Reports chronic pain (≥4 on 0-10 Numeric Rating Scale (NRS) on most days during the past 3 months)
- Prescribed opioids for pain management
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University School of Medicine Department of Psychiatry
Durham, North Carolina, 27705
About this study
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.
Read the 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.
- Conditions
- Chronic Pain, Opioid Use
- Being tested
- Mobile Neurofeedback App
- Keywords
- Chronic Pain, Opioids, Prescription Opioids, Pain, Musculoskeletal Pain, Mobile Apps, Mobile Health, Neurofeedback, EEG Feedback, Biofeedback, Alternative Therapy
- Medical subject headings
- Chronic Pain, Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Neurofeedback AppDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Mobile Neurofeedback App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (2)
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.
Measured: At 3 month follow-up (end of intervention)
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.
Measured: At 3 month follow-up (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start22 Jun 2022
- Primary completionSep 2023 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- CrossComm, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Eric B Elbogen, PhD, Principal investigator, Duke UniversityDonald K Shin, Principal investigator, CrossComm, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838925
- Sponsor's protocol ID
- Pro00106634
- Other IDs
- 1R41DA053011-01
- Status last verified
- Aug 2023
- First submitted
- 1 Apr 2021
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Mobile Devices for Neurofeedback to Reduce Opioid Use in Chronic Pain
- ClinicalTrials.gov ID
- NCT04838925
- Acronym / sponsor ID
- Pro00106634
- Conditions
- Chronic Pain, Opioid Use
- Keywords
- Chronic Pain, Opioids, Prescription Opioids, Pain, Musculoskeletal Pain, Mobile Apps, Mobile Health, Neurofeedback
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (actual)
- Lead sponsor
- CrossComm, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Duke University, National Institute on Drug Abuse (NIDA)
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile Neurofeedback | Experimental | Device: Mobile Neurofeedback AppParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Reports chronic pain (≥4 on 0-10 Numeric Rating Scale (NRS) on most days during the past 3 months)
- Prescribed opioids for pain management
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Neurofeedback AppNeurofeedback 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. | Device | Mobile Neurofeedback |
Primary outcome
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.
2 secondary outcomes
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)
Mobile App Usability assessed by the System Usability Scale
Time frame: At 3 month follow-up (end of intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain
Active, not recruiting
Pain and Opioids: Integrated Treatment In Veterans
Chronic Pain, Opioid-use Disorder
Active, not recruiting
Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
Opioid Use Disorder, Chronic Pain
Recruiting
Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
Chronic Post-surgical Pain, Chronic Post Operative Pain
Recruiting
Meditation for Older Adults With Chronic Low Back Pain
Chronic Low Back Pain
Recruiting
Behavioural Study in Chronic Pain : Creativity and Motivation, and Circuits Involved in Functional MRI
Chronic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric B Elbogen, PhD principal investigator
Duke University
Donald K Shin principal investigator
CrossComm, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Neurofeedback App in people with Chronic Pain and Opioid Use, run by CrossComm, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobile App Usage (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023; AzTrials last refreshed its copy on 31 Oct 2026.