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Brain Imaging for Spinal Cord Stimulation in Chronic Low Back Pain

This observational study is looking at how brain activity changes in 42 patients with chronic low back pain (pain lasting 12 weeks or longer) who are already receiving spinal cord stimulation (SCS) as part of their normal medical care. Researchers will use brain imaging to see if there are specific patterns (biomarkers) that predict how well SCS works. To join, you must be at least 21 years old and have chronic low back pain for which your doctor has recommended SCS. The study aims to see if changes in pain (VAS), depression (HAMD-17), and pain experience (MPQ) after two weeks of SCS are linked to brain imaging findings. The current recruitment status is unclear.

Study design
This is an observational study involving 42 participants. It is looking at brain activity in people receiving spinal cord stimulation for chronic low back pain.
What's involved
You would have two visits: a baseline visit for imaging and assessments, and a follow-up visit (possibly remote) two weeks after your SCS treatment for final assessments.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a follow-up visit two weeks after their spinal cord stimulation treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04658628

Brain Imaging Biomarkers for Response to Spinal Cord Stimulation in Patients With Chronic Low Back Pain

Recruiting
Not specifiedAges 21+Observational
University of California, Los Angeles
~42 participants
Updated 2025-10-02 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in VAS
Measured over Baseline and 2 weeks
+3 more outcomes measured

Conditions

Chronic Low-back Pain

Explore related trials

Chronic low back pain

Where it's being run

1 sites across 1 states
California1

Who to contact

Meskereen Tolossa
[email protected]
310-206-9187
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male or female ≥ 21 years of age at time of consent
Subject has been recommended to undergo an SCS trial for chronic back with or without leg pain by their pain management physician
Chronic low back pain as defined by persistent low back pain despite prior treatments that continues for 12 weeks or longer
Subject signs a valid, Institutional Review Board (IRB)-approved informed consent form (ICF) provided

Exclusion

Subject is a woman who is not using adequate contraception, is pregnant or breastfeeding or intends to become pregnant during the course of the study
Subject has previously undergone a spinal cord stimulation trial or is already implanted with an active implantable device(s) to treat their pain (Implantable Pulse Generators (IPGs), implantable drug pump, etc.) or pacemaker or implantable cardiac defibrillator
Subject is currently abusing alcohol or illicit drugs
Contraindications to MRIs or the need for recurrent body MRIs
Presence of cardiac pacemakers/defibrillators, implanted medication pumps, intra-cardiac lines, any intracranial implants (e.g., aneurysm clip, shunt, cochlear implant, electrodes) or other implanted stimulators

What this trial measures

  • Change in VASBaseline and 2 weeks

    The visual analog scale for pain is a continuous horizontal scale of length 100mm with the extremes of pain expressed on either end (left = no pain, right = worst pain).

  • Change in HAMD-17Baseline and 2 weeks

    The HAMD-17 is a 17-item scale that evaluates depressed mood, vegetative and cognitive symptoms of depression, and comorbid anxiety symptoms. The HAMD-17 was one of the first rating scales developed to quantify the severity of depressive symptomatology. First introduced by Max Hamilton in 1960, it has since become the most widely used and accepted outcome measure for evaluating depression severity. It provides ratings on current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) symptoms of depression, with the exception of hypersomnia, increased appetite, and concentration/indecision. The HAMD-17 was designed to be administered by a trained clinician using a semi-structured clinical interview. The 17-items are rated on either a 5-point (0-4) or a 3-point (0-2) scale.

  • Change in MPQBaseline and 2 weeks

    The Short-Form McGill Pain Questionnaire (SF-MPQ) is used for the measurement of pain. The measure is calculated by summing the point values for responses to 15 questions. Questions 1-11 deal with the sensory dimension of pain (i.e., the quality of the pain). Questions 12-15 deal with the affective dimension of pain (i.e., how the pain affects you). Subscores for the sensory and affective dimensions are calculated, in addition to a total McGill Pain Score. Higher scores generally correspond to an worsened subjective experience of pain.

  • Change in PASSBaseline and 2 weeks

    The PASS--20 measures fear and anxiety responses specific to pain. It includes four subscales that reflect aspects of avoidance behavior, cognitive anxiety, fear, and physiological anxiety. All items are rated on a scale from 0 (never) to 5 (always).