NCT06310226 · University of California, Los Angeles
Phenotyping Response to Spinal Cord Stimulation in Chronic Low Back Pain
What this study is about
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.
View original scientific 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.
Interventions
DEVICE
Epidural electrical spinal cord stimulator
Epidural electrical spinal cord stimulator turned on vs. turned off
Primary outcome measures
Detection of brain connectivity using functional MRI
Time frame: 1 year
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- Los Angeles, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 13, 2026 · Source of record for eligibility and locations