NCT04658628 Brain Imaging Biomarkers for Response to Spinal Cord Stimulation in Patients With Chronic Low Back Pain
| NCT ID | NCT04658628 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Los Angeles |
| Condition | Chronic Low-back Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 42 participants |
| Start Date | 2021-01-22 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 42 participants in total. It began in 2021-01-22 with a primary completion date of 2027-11.
⚠ 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
In this protocol, "Brain imaging biomarkers for response to Spinal Cord Stimulation in patients with chronic low back pain," the investigators plan to perform brain mapping studies in 42 patients who are undergoing spinal cord stimulation (SCS) for chronic low back pain (CLBP) as part of the participants normal clinical care during a 2-year period. This imagining study is completed for research purposes. There is no standard of care imaging for the participants. This study requires two visits in total. During the baseline visit, participants will undergo imaging acquisition protocol and corresponding assessments. Participants will have another follow-up visit (potentially remotely) for final assessments two weeks after the SCS treatment. The objective of the study is to investigate potential imaging biomarkers that can predict response to the SCS treatment. Specifically, the investigators hypothesize that the connectivity of a certain region of the brain (specifically the subgenual cingulate) prior to SCS may serve as a possible pre-operative imaging-based biomarker on response to SCS. The findings of the study may further enhance investigators understanding of the connectivity between brain areas that are critical to the therapeutic response to SCS in CLBP patients and that can be used as a putative biomarker to select patients who may respond to SCS.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04658628 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, 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 NCT04658628 currently recruiting?
Yes, NCT04658628 is actively recruiting participants. Contact the research team at MTolossa@mednet.ucla.edu for enrollment information.
Where is the NCT04658628 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT04658628 clinical trial?
NCT04658628 is sponsored by University of California, Los Angeles. The trial plans to enroll 42 participants.