RECRUITING

Phenotyping Response to Spinal Cord Stimulation in Chronic Low Back Pain

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Conditions

Chronic Low Back Pain

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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

Chronic low back pain (CLBP) is a debilitating condition and costly to treat. Long-term drug treatment often fails due to habituation, breakthrough of pain, or adverse effects of drug treatment. Opioid use to manage this pain has contributed to the opioid epidemic. Spinal cord stimulators have emerged as a promising treatment and reduces reliance on drugs. However, response to spinal cord stimulation (SCS) is unpredictable. It is difficult to predict which patients will respond positively to SCS because the physiological mechanism for treatment responsiveness is unclear. Therefore, the aim of this study is to investigate how spinal cord stimulators affect functional measures in patients with CLBP, including functional MRI, neurophysiology, gait analysis, and questionnaires. The results of this study can lead to the widespread adoption of spinal cord stimulators as a safe and effective therapy for CLBP, reducing the reliance on opioids and mitigating the opioid epidemic's impact.

Official Title

Characterizing Functional MRI Phenotypes in Response to Spinal Cord Stimulation in Chronic Low Back Pain

Quick Facts

Study Start:2024-04-11
Study Completion:2025-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06310226

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:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to give informed consent for participation in the trial and be able to comply with study-related requirements, procedures, and visits
  2. * Male or female, between the ages of 18 and 80 years (inclusive)
  3. * Current self-report of chronic low back pain (pain between the lower posterior margin of the rib cage and the horizontal gluteal fold), which has persisted for \> the past 3 months AND has resulted in pain on \> 50% of days in the past 6 months\* (\*Chronic low back pain criteria as defined by the NIH Pain Consortium Research Task Force (RTF) and BACPAC Minimum Dataset Working Group)
  4. * Already undergoing spinal cord stimulator treatment for chronic low back pain
  5. * Able to use their lower extremities
  6. * Able to tolerate fMRI and neurophysiological evaluation
  1. * Significant decision-making incapacity preventing informed consent
  2. * Any medical condition that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator.
  3. * Lifetime history of psychiatric disorder (schizophrenia, bipolar disorder with psychotic features, or other psychotic disorder), or current suicidal ideation
  4. * Any stimulation device and/or implant other than a spinal cord stimulator, such as a drug pump, pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS)
  5. * Life expectancy of less than 1 year
  6. * Pregnant or nursing (if female and sexually active, patient must be using a reliable form of birth control, be surgically sterile, or be at least 2 years post-menopausal)
  7. * Any documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency (not including marijuana use)
  8. * Participation in another clinical trial currently or within the past 30 days
  9. * Current treatment with electroconvulsive therapy (ECT) or transcranial magnetic stimulation (rTMS)
  10. * Conditions that preclude assessing brain function by fMRI: previous head injury, brain surgery, dementia, spinal cord injury, traumatic brain injury, cortical atrophy, serious neurological or medical illness, psychiatric illness, development disability, sensory impairment such as vision and hearing loss, history of birth weight less than 2000 grams and/or gestational age less than 34 weeks)
  11. * MRI compatibility: No major contraindication to MRI (e.g. claustrophobia, pacemaker, vascular stents, metallic ear tubes) and metal implants that would preclude use of MRI
  12. * History of spine surgery with existing instrumentation failure (i.e., broken screws or rods) or pseudarthrosis (lack of fusion) that could be the cause of CLBP
  13. * Any other comorbidity or condition that, in the opinion of the Investigator would make the subject unsuitable for the study or unable to comply with the study requirements

Contacts and Locations

Study Contact

Lily Chau, MD, PhD
CONTACT
310-267-1770
lilychau@mednet.ucla.edu
Daniel C Lu, MD, PhD
CONTACT
310-319-3475
dclu@mednet.ucla.edu

Principal Investigator

Daniel C Lu, MD, PhD
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Lily Chau, MD, PhD
STUDY_DIRECTOR
University of California, Los Angeles

Study Locations (Sites)

University of California, Los Angeles
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

  • Daniel C Lu, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles
  • Lily Chau, MD, PhD, STUDY_DIRECTOR, 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 Date2024-04-11
Study Completion Date2025-03-01

Study Record Updates

Study Start Date2024-04-11
Study Completion Date2025-03-01

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Low Back Pain