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Clinical Trials/NCT06025201
NCT06025201RecruitingNot Applicable

Characterization of Longitudinal EEG Biomarkers in Chronic Low Back Pain

Stanford University1 site in 1 country130 target enrollmentStarted: December 15, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
130
Locations
1
Primary Endpoint
Pain Intensity changes from baseline as assessed by the PROMIS current, 7 day maximal and 7 day average

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Single Arm

Experimental

All participants will complete all interventions

Intervention: Picture Viewing EEG (Behavioral)

Single Arm

Experimental

All participants will complete all interventions

Intervention: Resting State EEG (Behavioral)

Single Arm

Experimental

All participants will complete all interventions

Intervention: Stop Signal EEG (Behavioral)

Outcomes

Primary Outcomes

Pain Intensity changes from baseline as assessed by the PROMIS current, 7 day maximal and 7 day average

Time Frame: Baseline, 1-month, 2-month and 5-month follow-ups

Within subjects change in pain intensity from baseline to each follow up point. Pain intensity measures are 0-10 range with larger numbers indicating more pain

EEG late positive potential changes from baseline

Time Frame: Baseline, 1-month and 2-month follow-ups

Within subjects change in late positive potential from baseline to each follow up point.

EEG resting state functional connectivity changes from baseline

Time Frame: Baseline, 1-month and 2-month follow-ups

Within subjects change in resting state functional connectivity from baseline to each follow up point.

EEG error related negativity changes from baseline

Time Frame: Baseline, 1-month and 2-month follow-ups

Within subjects change in error related negativity from baseline to each follow up point.

Secondary Outcomes

  • Neuropsychological changes from baseline as assessed by the NIH toolbox(Baseline, 1-month and 2-month follow-ups)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Edward Lannon

Pain Psychologist

Stanford University

Study Sites (1)

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