Recruiting

EEG-Based Biomarkers

Sponsor:

Stanford University

Code:

NCT06025201

Conditions

Chronic Low-back Pain

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Resting State EEG

Picture Viewing EEG

Stop Signal EEG

Study Details

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 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.

Conditions

Chronic Low-back Pain

Healthy

Study ID

NCT06025201

Start date

Dec 15, 2023

Status verified date

May, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

130 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Single Arm

All participants will complete all interventions

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Stanford's Systems and Neuroscience Pain Lab

Recruiting

Palo Alto, California, United States, 94304

Contacts

More Information

Sponsor

Stanford University

Last update posted

May 15, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-05-15.