Chronic Low Back PainNCT06310226
Phenotyping Response to Spinal Cord Stimulation in Chronic Low Back Pain
A study testing Epidural electrical spinal cord stimulator in people with Chronic Low Back Pain, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Epidural electrical spinal cord stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2024to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
Chau
About this study
Official title: Characterizing Functional MRI Phenotypes in Response to Spinal Cord Stimulation in Chronic Low Back Pain
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.
Read the 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- Epidural electrical spinal cord stimulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural electrical spinal cord stimulatorDevice
Epidural electrical spinal cord stimulator turned on vs. turned off
| Study group | Role | What they receive |
|---|---|---|
| Responders to spinal cord stimulation | Experimental | Patients with chronic low back pain, with >50% pain reduction in response to spinal cord stimulation Receives: 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 Receives: Device: Epidural electrical spinal cord stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
Detection of brain waves using electroencephalography (EEG)
Characterizing EEG changes in chronic low back pain when the spinal cord stimulator is turned on versus when it is turned off.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start11 Apr 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Lu, MD, PhD, University of California, Los Angeles
- Investigators
- Daniel C Lu, MD, PhD, Principal investigator, University of California, Los AngelesLily Chau, MD, PhD, Study director, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310226
- Sponsor's protocol ID
- 23-000347
- Status last verified
- Feb 2026
- First submitted
- 4 Mar 2024
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Functional MRI Phenotypes in Response to Spinal Cord Stimulation in Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06310226
- Acronym / sponsor ID
- 23-000347
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Responders to spinal cord stimulation | Experimental | Device: Epidural electrical spinal cord stimulatorPatients with chronic low back pain, with >50% pain reduction in response to spinal cord stimulation |
| Non-responders to spinal cord stimulation | Experimental | Device: Epidural electrical spinal cord stimulatorPatients with chronic low back pain, with minimal to no pain reduction in response to spinal cord stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural electrical spinal cord stimulatorEpidural electrical spinal cord stimulator turned on vs. turned off | Device | Non-responders to spinal cord stimulation, Responders to spinal cord stimulation |
Primary outcome
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 secondary outcome
Detection of brain waves using electroencephalography (EEG)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel C Lu, MD, PhD principal investigator
University of California, Los Angeles
Lily Chau, MD, PhD study director
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural electrical spinal cord stimulator in people with Chronic Low Back Pain, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lily Chau, MD, PhD (310-267-1770, lilychau@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of brain connectivity using functional MRI (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.