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Detection of EEG-Based Biomarkers of Chronic Low Back Pain

Primary Purpose

Chronic Low-back Pain, Healthy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Resting State EEG
Picture Viewing EEG
Stop Signal EEG
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Low-back Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Single Arm

    Arm Description

    All participants will complete all interventions

    Outcomes

    Primary Outcome Measures

    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
    EEG resting state functional connectivity changes from baseline
    Within subjects change in resting state functional connectivity from baseline to each follow up point.
    EEG late positive potential changes from baseline
    Within subjects change in late positive potential from baseline to each follow up point.
    EEG error related negativity changes from baseline
    Within subjects change in error related negativity from baseline to each follow up point.

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    August 24, 2023
    Last Updated
    August 29, 2023
    Sponsor
    Stanford University
    Collaborators
    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06025201
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    February 2026 (Anticipated)
    Study Completion Date
    February 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stanford University
    Collaborators
    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Low-back Pain, Healthy

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    All participants will complete all interventions.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    130 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Single Arm
    Arm Type
    Experimental
    Arm Description
    All participants will complete all interventions
    Intervention Type
    Behavioral
    Intervention Name(s)
    Resting State EEG
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Picture Viewing EEG
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Stop Signal EEG
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Pain Intensity changes from baseline as assessed by the PROMIS current, 7 day maximal and 7 day average
    Description
    Within subjects change in pain intensity from baseline to each follow up point
    Time Frame
    Baseline, 3-month and 6-month follow-ups
    Title
    EEG resting state functional connectivity changes from baseline
    Description
    Within subjects change in resting state functional connectivity from baseline to each follow up point.
    Time Frame
    Baseline, 3-month and 6-month follow-ups
    Title
    EEG late positive potential changes from baseline
    Description
    Within subjects change in late positive potential from baseline to each follow up point.
    Time Frame
    Baseline, 3-month and 6-month follow-ups
    Title
    EEG error related negativity changes from baseline
    Description
    Within subjects change in error related negativity from baseline to each follow up point.
    Time Frame
    Baseline, 3-month and 6-month follow-ups
    Secondary Outcome Measure Information:
    Title
    Neuropsychological changes from baseline as assessed by the NIH toolbox
    Description
    Within subjects change in metrics of fluid and crystallized intelligence from baseline to each follow up point
    Time Frame
    Baseline, 3-month and 6-month follow-ups

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The investigators will support requests for data sharing in a timely manner. Prior to sharing data, the data will be redacted of all personal identifiers to prevent subject identification.

    Learn more about this trial

    Detection of EEG-Based Biomarkers of Chronic Low Back Pain

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