Brain imaging to predict response to spinal cord stimulation for chronic low back pain
Brain Imaging Biomarkers for Response to Spinal Cord Stimulation in Patients With Chronic Low Back Pain
This study is testing if brain scans can help predict how well spinal cord stimulation will work for people with chronic low back pain.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 42 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04658628 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate brain imaging biomarkers that may predict how patients with chronic low back pain respond to spinal cord stimulation (SCS). A total of 42 participants will undergo brain mapping studies as part of their normal clinical care over a two-year period. Participants will have two visits: one for baseline imaging and assessments, and a follow-up visit two weeks after SCS treatment for final assessments. The study focuses on the connectivity of specific brain regions to understand their relationship with treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older who have been recommended for spinal cord stimulation due to chronic low back pain lasting 12 weeks or longer.
Not a fit: Patients who are pregnant, breastfeeding, or have previously undergone spinal cord stimulation are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment approaches for patients with chronic low back pain.
How similar studies have performed: While the approach of using brain imaging biomarkers is innovative, similar studies have shown promise in understanding treatment responses in chronic pain management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female ≥ 21 years of age at time of consent * Subject has been recommended to undergo an SCS trial for chronic back with or without leg pain by their pain management physician * Chronic low back pain as defined by persistent low back pain despite prior treatments that continues for 12 weeks or longer * Subject signs a valid, Institutional Review Board (IRB)-approved informed consent form (ICF) provided Exclusion Criteria: * Subject is a woman who is not using adequate contraception, is pregnant or breastfeeding or intends to become pregnant during the course of the study * Subject has previously undergone a spinal cord stimulation trial or is already implanted with an active implantable device(s) to treat their pain (Implantable Pulse Generators (IPGs), implantable drug pump, etc.) or pacemaker or implantable cardiac defibrillator * Subject is currently abusing alcohol or illicit drugs * Contraindications to MRIs or the need for recurrent body MRIs * Presence of cardiac pacemakers/defibrillators, implanted medication pumps, intra-cardiac lines, any intracranial implants (e.g., aneurysm clip, shunt, cochlear implant, electrodes) or other implanted stimulators
Where this trial is running
Los Angeles, California
- University of California Los Angeles — Los Angeles, California, United States (Recruiting)
Study contacts
- Study coordinator: Meskereen Tolossa
- Email: MTolossa@mednet.ucla.edu
- Phone: 310-206-9187
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.