- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06310226
Phenotyping Response to Spinal Cord Stimulation in Chronic Low Back Pain
Characterizing Functional MRI Phenotypes in Response to Spinal Cord Stimulation in Chronic Low Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Electrical stimulation of neural tissues can be effective and reduce reliance on drugs, and epidural spinal cord stimulation (SCS) is often used to treat chronic low back pain (CLBP). Despite a half-century of clinical use, the mechanism of action of SCS remains unclear. Many patients fail to respond to SCS, and lacking a thorough understanding of the biological processes underlying SCS, there are no established predictors of treatment response to SCS. The application of SCS today is dependent on an empirical trial-and-error approach, which is expensive, time consuming, and frustrating for the patient. Even with the advent of improved stimulation technology and novel stimulation strategies (e.g., high frequency, burst stimulation, etc.), device failure rates remain high. CLBP is a multi-faceted process involving abnormal processing in the sensorimotor cortices, prefrontal cortex, insula, thalamus, limbic system, cerebellum, and brainstem nuclei including the periaqueductal gray, locus coeruleus, and dorsal raphe nuclei, all of which function in the context of myriad individual psychosocial factors.
The goal of this study is to develop a quantitative description of the neurophysiological processes associated with the sensation of pain and identify the signature(s) of pain, the neurophysiological pain connectome (NPC), that may guide treatment more effectively. The investigators hypothesize CLBP is marked by a pattern of pathological activity resulting from interactions among different brain networks. The investigators theorize the spatiotemporal patterns of activity among these networks, which are reflected in the NPC, are maladaptive and expressed as abnormal cognitive, affective, and sensorimotor expressions of chronic pain. Because CLBP is a complex disorder, a fundamentally different approach is necessary to assess the many facets of the NPC using comprehensive multi-modal assessments.
Investigators will use: 1. functional and diffusion MRI to quantify brain functional and microstructural connectivity; 2. electroencephalography (EEG); 3. gait kinematics; and 4. electrophysiology (somatosensory evoked potential, SSEP and pain-related evoked potentials, PREPs) to evaluate the neurotransmission of pain. Investigators will then correlate patterns in the NPC with a range of patient-reported outcomes including the domains of the PROMIS questionnaires, and combine this information to generate models based on the patterns in the NPC most closely associated with specific aspects of pain and the patient experience.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lily Chau, MD, PhD
- Phone Number: 310-267-1770
- Email: lilychau@mednet.ucla.edu
Study Contact Backup
- Name: Daniel C Lu, MD, PhD
- Phone Number: 310-319-3475
- Email: dclu@mednet.ucla.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- Recruiting
- University of California, Los Angeles
-
Contact:
- Chau
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Responders to spinal cord stimulation
Patients with chronic low back pain, with >50% pain reduction in response to spinal cord stimulation
|
Epidural electrical spinal cord stimulator turned on vs. turned off
|
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
|
Epidural electrical spinal cord stimulator turned on vs. turned off
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detection of brain waves using electroencephalography (EEG)
Time Frame: 1 year
|
Characterizing EEG changes in chronic low back pain when the spinal cord stimulator is turned on versus when it is turned off.
|
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurological gait kinematics assessment
Time Frame: 1 year
|
Characterizing changes in gait kinematics during a 10-minute walk test in chronic low back pain when the spinal cord stimulator is turned on versus when it is turned off.
|
1 year
|
Neurophysiological functional assessment using somatosensory evoked potential (SSEP)
Time Frame: 1 year
|
Characterizing electrophysiological changes in SSEPs to evaluate the neurotransmission of pain when the spinal cord stimulator is turned on versus when it is turned off.
|
1 year
|
Neurophysiological functional assessment using pain-related evoked potential (PREP)
Time Frame: 1 year
|
Characterizing electrophysiological changes in PREPs to evaluate the neurotransmission of pain when the spinal cord stimulator is turned on versus when it is turned off.
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Daniel C Lu, MD, PhD, University of California, Los Angeles
- Study Director: Lily Chau, MD, PhD, University of California, Los Angeles
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-000347
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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