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RecruitingNCT06025201Updated May 15, 2026

Detection of EEG-Based Biomarkers of Chronic Low Back Pain

An interventional study of Resting State EEG and Picture Viewing EEG in Chronic Low-back Pain and Healthy, sponsored by Stanford University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-15.

Sponsored by Stanford University · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Dec 2023; still recruiting 2 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Low-back Pain
  • Healthy
03

In context

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Current diagnosis of Chronic Low Back Pain

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
130 participants (estimated)

Study arms

  • Experimental
    Single Arm

    All participants will complete all interventions

    Behavioral: Resting State EEG · Behavioral: Picture Viewing EEG · Behavioral: Stop Signal EEG

Interventions

  • BehavioralResting 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.

  • BehavioralPicture 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.

  • BehavioralStop 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.

06

What researchers measure

Primary outcomes

  1. 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. Pain intensity measures are 0-10 range with larger numbers indicating more pain

    Time frame: Baseline, 1-month, 2-month and 5-month follow-ups

  2. EEG resting state functional connectivity changes from baseline

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

    Time frame: Baseline, 1-month and 2-month follow-ups

  3. EEG late positive potential changes from baseline

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

    Time frame: Baseline, 1-month and 2-month follow-ups

  4. EEG error related negativity changes from baseline

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

    Time frame: Baseline, 1-month and 2-month follow-ups

Secondary outcomes

  1. 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

    Time frame: Baseline, 1-month and 2-month follow-ups

07

Study locations

1 of 1 sites recruiting
  • Stanford's Systems and Neuroscience Pain Lab
    Palo Alto, California 94304, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06025201
Lead sponsor
Stanford University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Responsible party
Edward Lannon (Pain Psychologist, Stanford University) — Principal investigator
First posted
Sep 6, 2023
Start date
Dec 15, 2023
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
May 15, 2026

Study contacts

Omar Altirkawi
Contact
omar97@stanford.edu
650-724-8426

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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