Detection of EEG-Based Biomarkers of Chronic Low Back Pain

NCT06025201 | Recruiting DMC

• 2 other identifiers: 717781K23AR083171-01
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Chronic Low-back Pain

Outcome Measures

Primary Outcomes (4)

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

  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

  Baseline, 1-month, 2-month and 5-month follow-ups

• EEG resting state functional connectivity changes from baseline

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

  Baseline, 1-month and 2-month follow-ups

• EEG late positive potential changes from baseline

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

  Baseline, 1-month and 2-month follow-ups

• EEG error related negativity changes from baseline

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

  Baseline, 1-month and 2-month follow-ups

Secondary Outcomes (1)

• Neuropsychological changes from baseline as assessed by the NIH toolbox

  Baseline, 1-month and 2-month follow-ups

Study Arms (1)

Single Arm

EXPERIMENTAL

All participants will complete all interventions

Behavioral: Resting State EEG; Behavioral: Picture Viewing EEG; Behavioral: Stop Signal EEG

Interventions

Resting State EEG BEHAVIORAL

During this intervention, participants will be asked to not think about anything in particular while EEG is recorded. Resting state will be conducted with either the participants having their eyes open, or eyes closed.

Single Arm

Picture Viewing EEG BEHAVIORAL

During this intervention, participants will view emotionally charged pictures for a short period of time. Afterwards, participants will be asked to rate their emotional reactions to the pictures. EEG will be recorded during this intervention.

Single Arm

Stop Signal EEG BEHAVIORAL

During this intervention, participants will be asked to respond quickly to a visual stimulus with a button press. At times, participants will be asked to inhibit their responses. EEG will be recorded during this intervention.

Single Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current diagnosis of Chronic Low Back Pain

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Stanford's Systems and Neuroscience Pain Lab

Palo Alto, California, 94304, United States

RECRUITING

Central Study Contacts

Omar Altirkawi

CONTACT

650-724-8426; omar97@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pain Psychologist

Model Details: All participants will complete all interventions.

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: September 6, 2023
• Study Start: December 15, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)