NCT06025201 Detection of EEG-Based Biomarkers of Chronic Low Back Pain
| NCT ID | NCT06025201 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stanford University |
| Condition | Chronic Low-back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2023-12-15 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 130 participants in total. It began in 2023-12-15 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06025201 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Chronic Low-back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06025201 currently recruiting?
Yes, NCT06025201 is actively recruiting participants. Contact the research team at omar97@stanford.edu for enrollment information.
Where is the NCT06025201 trial being conducted?
This trial is being conducted at Palo Alto, United States.
Who is sponsoring the NCT06025201 clinical trial?
NCT06025201 is sponsored by Stanford University. The trial plans to enroll 130 participants.