Brain scans may reveal who benefits from spinal cord stimulators for back pain
NCT ID NCT06310226
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at how spinal cord stimulators change brain activity in people with chronic low back pain. Researchers will use fMRI scans to compare brain connectivity when the device is on versus off. The goal is to find patterns that predict who will respond well to this treatment, potentially reducing the need for painkillers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Epidural electrical spinal cord stimulator (device)
- What this could lead to
- If successful, this could help doctors predict which patients with chronic low back pain will benefit from spinal cord stimulation, reducing reliance on painkillers.
- What could go wrong
- This is a small, early-stage study with only 20 participants, focused on brain imaging rather than direct pain relief. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2024
- Expected to finish
-
May 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Chronic low-back pain are added.
Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
University of California, Los Angeles
RECRUITINGLos Angeles, California, 90095, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can naming your feelings predict back pain relief?
- Scientists map the daily rhythms of chronic pain
- Can yoga ease back pain when recovery looks unlikely?
- Can exercise retraining rewire the nervous system in chronic back pain?
- Can gentle back vibration reset the Brain's pain response?
- A vibrating belt might soothe the back pain that plagues desk jobs