Clinical trial NCT06025201: Detection of EEG-Based Biomarkers of Chronic Low Back Pain
Official title: Characterization of Longitudinal EEG Biomarkers in Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Low-back Pain
Healthy
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2023-09-06
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will complete all interventions.
Primary purpose: OTHER

Brief summary: Chronic low back pain (CLBP) is a pervasive disorder affecting up to one-fifth of adults globally and is the single greatest cause of disability worldwide. Despite the high prevalence and detrimental impact of CLBP, its treatments and mechanisms remain largely unclear. Biomarkers that predict symptom progression in CLBP support precision-based treatments and ultimately aid in reducing suffering. Longitudinal brain-based resting-state neuroimaging of patients with CLBP has revealed neural networks that predict pain chronification and its symptom progression. Although early findings suggest that measurements of brain networks can lead to the development of prognostic biomarkers, the predictive ability of these models is strongest for short-term follow-up. Measurements of different neural systems may provide additional benefits with better predictive power.

Emotional and cognitive dysfunction is common in CLBP, occurring at the behavioral and cerebral level, presenting a unique opportunity to detect prognostic brain-based biomarkers. Likewise, improvements in electroencephalogram (EEG) neuroimaging strategies have led to increased spatial resolution, enabling researchers to overcome the limitations of classically used neuroimaging modalities (e.g., magnetic resonance imaging \[MRI\] and functional MRI), such as high cost and limited accessibility. Using longitudinal EEG, this patient-oriented research project will provide a comprehensive neural picture of emotional, cognitive, and resting-state networks in patients with CLBP, which will aid in predicting symptom progression in CLBP. Through this award, the investigators will use modern EEG source analysis strategies to track biomarkers at baseline and 1- and 2-month follow-ups and their covariance with markers for pain and emotional and cognitive dysfunction. A 5-month follow up will also be used to only assess patient reported outcomes. In Aim 1, the investigators will identify and characterize differences in resting-state, emotional, and cognitive networks between patients with CLPB and age/sex-matched controls. In Aim 2, the investigators will identify within-subject changes across time and their relationship with clinical symptoms. In Aim 3, as an exploratory aim, the investigators will apply machine- and deep-learning strategies to detect a comprehensive signature of CLBP using EEG features from resting-state, emotional, and cognitive networks.


Eligibility criteria: Inclusion Criteria:

* Current diagnosis of Chronic Low Back Pain

Exclusion Criteria:

* Current diagnosis of cancer
* Severe psychiatric conditions
* Pending personal litigation relating to an injury or receiving workers' compensation benefits
* Being a non-English speaker.

Primary outcomes:
measure: Pain Intensity changes from baseline as assessed by the PROMIS current, 7 day maximal and 7 day average
timeFrame: Baseline, 1-month, 2-month and 5-month follow-ups
measure: EEG resting state functional connectivity changes from baseline
timeFrame: Baseline, 1-month and 2-month follow-ups
measure: EEG late positive potential changes from baseline
timeFrame: Baseline, 1-month and 2-month follow-ups
measure: EEG error related negativity changes from baseline
timeFrame: Baseline, 1-month and 2-month follow-ups
Secondary outcomes:
measure: Neuropsychological changes from baseline as assessed by the NIH toolbox
timeFrame: Baseline, 1-month and 2-month follow-ups
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford's Systems and Neuroscience Pain Lab
state: California
Study officials:
References: