Brain Imaging Biomarkers for Response to Spinal Cord Stimulation in Patients With Chronic Low Back Pain

NCT ID: NCT04658628

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-22
• Study Completion Date: 2027-11-30

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.

Conditions

Chronic Low-back Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Evangelia C. Tsolaki, MSc, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of California Los Angeles

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Meskereen Tolossa

Role: CONTACT

MTolossa@mednet.ucla.edu

310-206-9187

Facility Contacts

Evangelia Tsolaki

Role: primary

Etsolaki@mednet.ucla.edu

3108254321

Other Identifiers

IRB#20-001870

Identifier Type: -

Identifier Source: org_study_id