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
About this trial
This is an interventional other trial for Chronic Low-back Pain
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.
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
NCT ID
NCT06025201
First Posted
August 24, 2023
Last Updated
August 29, 2023
Sponsor
Stanford University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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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