RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-01-22
Study Completion:2024-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04658628

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female ≥ 21 years of age at time of consent
  2. * Subject has been recommended to undergo an SCS trial for chronic back with or without leg pain by their pain management physician
  3. * Chronic low back pain as defined by persistent low back pain despite prior treatments that continues for 12 weeks or longer
  4. * Subject signs a valid, Institutional Review Board (IRB)-approved informed consent form (ICF) provided
  1. * 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
  2. * 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
  3. * Subject is currently abusing alcohol or illicit drugs
  4. * Contraindications to MRIs or the need for recurrent body MRIs
  5. * 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

Contacts and Locations

Study Contact

Wenxin Wei
CONTACT
4242725397
Wenxinwei@mednet.ucla.edu

Study Locations (Sites)

University of California Los Angeles
Los Angeles, California, 90067
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-22
Study Completion Date2024-11

Study Record Updates

Study Start Date2021-01-22
Study Completion Date2024-11

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Low-back Pain