Detection of EEG-Based Biomarkers of Chronic Low Back Pain

Healthy Clinical Trial

Official title:

Characterization of Longitudinal EEG Biomarkers in Chronic Low Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06025201
• Other study ID #: 71778
• Secondary ID: 1K23AR083171-01
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: February 2026

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: Omar Altirkawi
• Phone: 650-724-8426
• Email: omar97[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 3- and 6-month follow-ups and their covariance with markers for pain and emotional and cognitive dysfunction. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Healthy
• Low Back Pain

Intervention

Behavioral:
• Resting State EEG
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.
• Picture Viewing EEG
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.
• Stop Signal EEG
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.

Locations

Country	Name	City	State
United States	Stanford's Systems and Neuroscience Pain Lab	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, 3-month and 6-month follow-ups
Primary	EEG resting state functional connectivity changes from baseline	Within subjects change in resting state functional connectivity from baseline to each follow up point.	Baseline, 3-month and 6-month follow-ups
Primary	EEG late positive potential changes from baseline	Within subjects change in late positive potential from baseline to each follow up point.	Baseline, 3-month and 6-month follow-ups
Primary	EEG error related negativity changes from baseline	Within subjects change in error related negativity from baseline to each follow up point.	Baseline, 3-month and 6-month follow-ups
Secondary	Neuropsychological changes from baseline as assessed by the NIH toolbox	Within subjects change in metrics of fluid and crystallized intelligence from baseline to each follow up point	Baseline, 3-month and 6-month follow-ups