What side effects are associated with this type of intervention?

Common treatments for chronic pain that are similar to neurofeedback, such as cognitive behavioral therapy (CBT), mindfulness-based stress reduction (MBSR), and other mind-body therapies, generally have minimal side effects. These can include mild discomfort or emotional distress as patients confront and process their pain. Neurofeedback itself is typically well-tolerated, with rare side effects that may include headache, fatigue, or dizziness. Overall, these non-pharmacological treatments are considered safe with few adverse events reported.

What prior FDA approvals exist?

The FDA has approved several neuromodulatory devices for the treatment of chronic pain, including transcranial magnetic stimulation (TMS) and noninvasive vagus nerve stimulation (nVNS). TMS has shown efficacy in treating episodic migraine with aura, providing pain relief and sustained pain-free responses. Similarly, nVNS has been beneficial for acute treatment of episodic migraine. These devices offer non-pharmacologic options for pain management, similar to the mobile neurofeedback app being studied, which aims to teach self-regulation of brain function through real-time feedback from brain activity.

What other types of research exist?

Promising, novel alternatives to mobile neurofeedback apps for chronic pain patients include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in reducing pain in migraine patients and may be applicable to other chronic pain conditions. 2) Remote Electrical Neuromodulation, which has demonstrated significant pain relief in migraine treatment and could be explored for broader chronic pain management. 3) Noninvasive Vagus Nerve Stimulation (nVNS), which has potential benefits for acute pain relief and may be adapted for chronic pain conditions. These alternatives leverage advanced technology to modulate neural activity and offer non-invasive pain management options.

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Behavioural Intervention

Mobile Neurofeedback for Chronic Pain

N/A

Waitlist Available

Led By Eric B Elbogen, PhD

Research Sponsored by CrossComm, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prescribed opioids for pain management

Reports chronic pain (≥4 on 0-10 Numeric Rating Scale (NRS) on most days during the past 3 months)

Must not have

Plans to have pain-related surgery in the next 3 months

History of seizures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 3 month follow-up (end of intervention)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new mobile app that helps people with chronic pain manage their condition by showing them real-time feedback on their brain activity. Participants will use the app and a special headset regularly over a few months. The goal is to see if this method can help reduce their pain and reliance on opioids.

Who is the study for?

This trial is for individuals who experience chronic pain (rated ≥4 on a scale of 0-10) most days over the past three months and are prescribed opioids. It's not suitable for those with a history of seizures, planned pain-related surgery within three months, or implanted devices that could be affected by EEG.

What is being tested?

The study is testing a mobile neurofeedback app used in conjunction with an EEG headset. Participants will use this setup for 10 minutes at a time, four times weekly over twelve weeks to see if it helps reduce opioid use in chronic pain management.

What are the potential side effects?

Since this trial involves non-invasive neurofeedback through an app and EEG headset, side effects may be minimal but can include discomfort from wearing the headset or potential stress from engaging with the neurofeedback process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am taking opioids for pain management.

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I have experienced chronic pain most days in the last 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I plan to undergo surgery for pain relief within the next 3 months.

Select...

I have a history of seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 3 month follow-up (end of intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 3 month follow-up (end of intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 month follow-up (end of intervention) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mobile App Usage

Secondary study objectives

Mobile App Satisfaction assessed on a 5-point Likert scale (1: very dissatisfied - 5: very satisfied)

Mobile App Usability assessed by the System Usability Scale

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Mobile NeurofeedbackExperimental Treatment1 Intervention

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.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for chronic pain include pharmacologic options like NSAIDs, acetaminophen, and opioids, which work by reducing inflammation and altering pain signaling pathways. Non-pharmacologic treatments such as cognitive behavioral therapy (CBT) and exercise therapy focus on changing pain perception and improving physical function. Treatments like mobile neurofeedback apps and virtual reality (VR) therapy provide real-time feedback and immersive experiences that help patients self-regulate brain function and reduce pain through neurophysiologic changes. These approaches are crucial for chronic pain patients as they offer alternative methods to manage pain, potentially reducing reliance on opioids and improving overall quality of life.

Music as an Adjunct to Opioid-Based Analgesia.Challenges and opportunities in translational pain research - An opinion paper of the working group on translational pain research of the European pain federation (EFIC).Pathophysiologic Approach to Pain Therapy for Complex Pain Entities: A Narrative Review.