Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04658628
Recruitment Status : Recruiting
First Posted : December 8, 2020
Last Update Posted : January 26, 2021
Sponsor:
Information provided by (Responsible Party):
Evangelia C. Tsolaki, MSc, PhD, University of California, Los Angeles

Brief Summary:
In this protocol, "Brain imaging biomarkers for response to Spinal Cord Stimulation in patients with chronic low back pain," the investigators plan to perform brain mapping studies in 42 patients who are undergoing spinal cord stimulation (SCS) for chronic low back pain (CLBP) as part of the participants normal clinical care during a 2-year period. This imagining study is completed for research purposes. There is no standard of care imaging for the participants. This study requires two visits in total. During the baseline visit, participants will undergo imaging acquisition protocol and corresponding assessments. Participants will have another follow-up visit (potentially remotely) for final assessments two weeks after the SCS treatment. The objective of the study is to investigate potential imaging biomarkers that can predict response to the SCS treatment. Specifically, the investigators hypothesize that the connectivity of a certain region of the brain (specifically the subgenual cingulate) prior to SCS may serve as a possible pre-operative imaging-based biomarker on response to SCS. The findings of the study may further enhance investigators understanding of the connectivity between brain areas that are critical to the therapeutic response to SCS in CLBP patients and that can be used as a putative biomarker to select patients who may respond to SCS.

Condition or disease
Chronic Low-back Pain

Layout table for study information
Study Type : Observational
Estimated Enrollment : 42 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brain Imaging Biomarkers for Response to Spinal Cord Stimulation in Patients With Chronic Low Back Pain
Actual Study Start Date : January 22, 2021
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain




Primary Outcome Measures :
  1. Change in VAS [ Time Frame: Baseline 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).

  2. Change in HAMD-17 [ Time Frame: Baseline 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.

  3. Change in MPQ [ Time Frame: Baseline 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.

  4. Change in PASS [ Time Frame: Baseline 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults recommended to undergo an SCS trial for chronic back with or without leg pain by their pain management physician
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04658628


Contacts
Layout table for location contacts
Contact: Wenxin Wei 4242725397 Wenxinwei@mednet.ucla.edu

Locations
Layout table for location information
United States, California
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90067
Contact: Wenxin Wei    310-817-0451      
Sponsors and Collaborators
University of California, Los Angeles
Layout table for additonal information
Responsible Party: Evangelia C. Tsolaki, MSc, PhD, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04658628    
Other Study ID Numbers: IRB#20-001870
First Posted: December 8, 2020    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Pain
Neurologic Manifestations