Phenotyping Response to Spinal Cord Stimulation in Chronic Low Back Pain

NCT06310226 | Recruiting FDA Device

• 1 other identifier: 23-000347
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Detection of brain connectivity using functional MRI

  The primary objective of this study is to determine the effects of spinal cord stimulation on chronic low back pain by comparing the functional changes in the central nervous system as measured by fMRI when the spinal cord stimulator is turned on versus when it is turned off.

  1 year

Secondary Outcomes (1)

• Detection of brain waves using electroencephalography (EEG)

  1 year

Other Outcomes (3)

• Neurological gait kinematics assessment

  1 year

• Neurophysiological functional assessment using somatosensory evoked potential (SSEP)

  1 year

• Neurophysiological functional assessment using pain-related evoked potential (PREP)

  1 year

Study Arms (2)

Responders to spinal cord stimulation

EXPERIMENTAL

Patients with chronic low back pain, with \>50% pain reduction in response to spinal cord stimulation

Device: Epidural electrical spinal cord stimulator

Non-responders to spinal cord stimulation

EXPERIMENTAL

Patients with chronic low back pain, with minimal to no pain reduction in response to spinal cord stimulation

Device: Epidural electrical spinal cord stimulator

Interventions

Epidural electrical spinal cord stimulator DEVICE

Epidural electrical spinal cord stimulator turned on vs. turned off

Non-responders to spinal cord stimulation; Responders to spinal cord stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to give informed consent for participation in the trial and be able to comply with study-related requirements, procedures, and visits
• Male or female, between the ages of 18 and 80 years (inclusive)
• 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)
• Already undergoing spinal cord stimulator treatment for chronic low back pain
• Able to use their lower extremities
• Able to tolerate fMRI and neurophysiological evaluation

You may not qualify if:

• Significant decision-making incapacity preventing informed consent
• Any medical condition that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator.
• Lifetime history of psychiatric disorder (schizophrenia, bipolar disorder with psychotic features, or other psychotic disorder), or current suicidal ideation
• 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)
• Life expectancy of less than 1 year
• 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)
• Any documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency (not including marijuana use)
• Participation in another clinical trial currently or within the past 30 days
• Current treatment with electroconvulsive therapy (ECT) or transcranial magnetic stimulation (rTMS)
• 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)
• 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
• 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
• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

Study Officials

• Daniel C Lu, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Lily Chau, MD, PhD

  University of California, Los Angeles

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Neuroplasticity and Repair Laboratory

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 15, 2024
• Study Start: April 11, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)