Phenotyping Response to Spinal Cord Stimulation in Chronic Low Back Pain

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT06310226
Status
Recruiting
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Conditions

  • Chronic Low Back Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Epidural electrical spinal cord stimulator — DEVICE
    Epidural electrical spinal cord stimulator turned on vs. turned off

Study Details

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.

Key Dates

Start date
Apr 11, 2024
Status verified
Feb 2026
Primary completion
Dec 1, 2026
Completion
May 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Responders to spinal cord stimulation
    Patients with chronic low back pain, with \>50% pain reduction in response to spinal cord stimulation
  • Experimental: Non-responders to spinal cord stimulation
    Patients with chronic low back pain, with minimal to no pain reduction in response to spinal cord stimulation

Primary Outcome Measure

Detection of brain connectivity using functional MRI [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90095
Chau

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By research site
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