Detection of EEG-Based Biomarkers of Chronic Low Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Resting State EEG, Picture Viewing EEG, Stop Signal EEG.
- Who it may be relevant to
- Registry conditions: Chronic Low-back Pain, Healthy. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Characterization of Longitudinal EEG Biomarkers in Chronic Low Back Pain
Overview
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.
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.
Primary outcome measures
- Pain Intensity changes from baseline as assessed by the PROMIS current, 7 day maximal and 7 day average [Time frame: Baseline, 1-month, 2-month and 5-month follow-ups]
- EEG resting state functional connectivity changes from baseline [Time frame: Baseline, 1-month and 2-month follow-ups]
- EEG late positive potential changes from baseline [Time frame: Baseline, 1-month and 2-month follow-ups]
- EEG error related negativity changes from baseline [Time frame: Baseline, 1-month and 2-month follow-ups]
Secondary outcome measures (1)
- Neuropsychological changes from baseline as assessed by the NIH toolbox [Time frame: Baseline, 1-month and 2-month follow-ups]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Stanford's Systems and Neuroscience Pain Lab — Palo Alto
Identifiers
NCT: NCT06025201 · 71778 · 1K23AR083171-01