Neurophysiological Assessments for Chronic Pain and Opioid Risk
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how people with chronic pain avoid actions or activities that might cause pain, known as Pain Avoidance Behavior. Researchers seek to identify connections between behavior, brain function, and the risk of developing an opioid addiction. The trial involves two groups: individuals with Complex Regional Pain Syndrome (CRPS) and healthy individuals with known neurological conditions. It suits those who have experienced severe CRPS pain on one side of their body for over six months and have sensitivity to touch. Participants will undergo various tests, including brain scans. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance the understanding and treatment of chronic pain.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators for more details.
What prior data suggests that these neurophysiological assessments are safe?
Research has shown that brain imaging techniques like EEG and MEG are being explored to better understand chronic pain. Many studies have used these methods without major safety concerns.
EEG, a non-invasive way to record brain activity, is commonly used in studies, including those on chronic pain, and is generally well-tolerated, with most people not experiencing side effects. Similarly, MEG measures magnetic fields from brain activity and is also safe and non-invasive.
These techniques are not new and have a strong safety record in human studies, suggesting they are safe tools for studying brain function in chronic pain research. While this study focuses on understanding pain avoidance behaviors, the use of these brain imaging methods is supported by their history of safe use in similar research.12345Why are researchers excited about this trial?
Researchers are excited about the trial because it explores how pain avoidance behavior impacts chronic pain management and opioid risk. Unlike traditional treatments that often rely on medication to manage symptoms, this approach focuses on understanding and modifying the behaviors that contribute to pain. By targeting these behaviors, the method aims to reduce reliance on opioids, decrease pain levels, and improve patient quality of life. This behavioral focus provides a new avenue for managing chronic pain, offering hope for those who haven't found relief with standard medication-based treatments.
What evidence suggests that this trial's treatments could be effective for chronic pain?
Research has shown that tests like EEG, which record brain activity, can enhance understanding of chronic pain. In this trial, participants will undergo neurophysiological assessments, including EEG, to identify patterns in brain activity linked to chronic pain. Studies have found that these patterns might aid in developing better treatments. Additionally, computer analysis, known as machine learning, can predict pain outcomes from EEG data. This could lead to more personalized and effective treatments for individuals with chronic pain.16789
Who Is on the Research Team?
Hubert Fernandez, MD
Principal Investigator
The Cleveland Clinic
Are You a Good Fit for This Trial?
This trial is for adults with chronic pain, rating their daily pain ≥5 out of 10 for the past month. They must have CRPS I or II, allodynia, and severe pain that hasn't improved after six months of treatment. Participants need to be willing to undergo brain scans and tests, and have mostly one-sided pain.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Training and Initial Assessment
Participants undergo training to understand the task and initial assessments including neuropsychological and pain assessments
Experimental Task
Participants perform the instrumental pain avoidance learning task while MEG and other autonomic measurements are recorded
Follow-up
Participants are monitored for safety and effectiveness after the experimental task
What Are the Treatments Tested in This Trial?
Interventions
- Electroencephalography (EEG)/Magnetoencephalography (MEG)/MRI
- Pain Avoidance Behavior
Trial Overview
The study uses EEG/MEG/MRI scans to understand how people with chronic pain try to avoid more pain and how this might relate to the risk of opioid addiction. It looks at behaviors, brain activity patterns, traits, and risk factors linked to avoiding pain.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patients with CRPS diagnosis
Healthy controls with known Neurological Disorders
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Cleveland Clinic
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Citations
Resting-state electroencephalography and ...
This systematic review synthesizes evidence on how resting-state M/EEG might serve as a diagnostic biomarker of chronic pain.
Exploring electroencephalographic chronic pain biomarkers
Electroencephalography (EEG) is a cost-effective and widely accessible tool for assessing brain function. Previous studies have linked chronic pain to standard ...
Systematic Review of the Effectiveness of Machine ...
Recent attempts to utilize machine learning (ML) to predict pain-related outcomes from Electroencephalogram (EEG) data demonstrate promising results.
Magnetoencephalography reveals increased slow-to-fast ...
Our data show significantly higher alpha power ratios in patients with chronic pain. MEG brain maps showed group-wise significant ...
Changes in Resting-State Brain Activity After Cognitive ...
We conducted this study to use resting-state MEG data and investigate the neural mechanisms underlying the outcomes of a CBT program for patients with chronic ...
Exploring electroencephalographic chronic pain biomarkers
We used EEG data from eight independent studies involving people with chronic pain to investigate how brain connectivity relates to pain intensity. Methods.
7.
thejournalofheadacheandpain.biomedcentral.com
thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/s10194-024-01857-5Resting-state electroencephalography and ...
Magnetoencephalography/electroencephalography (M/EEG) can provide insights into migraine pathophysiology and help develop clinically valuable biomarkers.
Brain imaging tests for chronic pain: medical, legal and ...
Brain imaging (for example, functional MRI, PET, EEG and magnetoencephalography) is widely considered to have potential for diagnosis, ...
9.
journals.lww.com
journals.lww.com/pain/fulltext/2021/12000/dynamics_of_brain_function_in_patients_with.11.aspxDynamics of brain function in patients with chronic pain...
To this end, we applied microstate analysis to eyes-open and eyes-closed resting-state electroencephalography data of 101 patients suffering from chronic pain ...
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