Detection of EEG-Based Biomarkers of Chronic Low Back Pain

Sponsor
Stanford University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06025201
Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)
130
1
26.1

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Resting State EEG
  • Behavioral: Picture Viewing EEG
  • Behavioral: Stop Signal EEG
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
All participants will complete all interventions.All participants will complete all interventions.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Characterization of Longitudinal EEG Biomarkers in Chronic Low Back Pain
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2026
Anticipated Study Completion Date :
Feb 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single Arm

All participants will complete all interventions

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.

Behavioral: 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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Pain Intensity changes from baseline as assessed by the PROMIS current, 7 day maximal and 7 day average [Baseline, 3-month and 6-month follow-ups]

    Within subjects change in pain intensity from baseline to each follow up point

  2. EEG resting state functional connectivity changes from baseline [Baseline, 3-month and 6-month follow-ups]

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

  3. EEG late positive potential changes from baseline [Baseline, 3-month and 6-month follow-ups]

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

  4. EEG error related negativity changes from baseline [Baseline, 3-month and 6-month follow-ups]

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

Secondary Outcome Measures

  1. Neuropsychological changes from baseline as assessed by the NIH toolbox [Baseline, 3-month and 6-month follow-ups]

    Within subjects change in metrics of fluid and crystallized intelligence from baseline to each follow up point

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Edward Lannon, Pain Psychologist, Stanford University
ClinicalTrials.gov Identifier:
NCT06025201
Other Study ID Numbers:
  • 71778
  • 1K23AR083171-01
First Posted:
Sep 6, 2023
Last Update Posted:
Sep 6, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 6, 2023