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

Chronic Low-back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04658628
• Other study ID #: IRB#20-001870
• Status: Recruiting
• Start date: January 22, 2021
• Est. completion date: November 2024

Study information

• Verified date: December 2023
• Source: University of California, Los Angeles
• Contact: Wenxin Wei
• Phone: 4242725397
• Email: Wenxinwei[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Locations

Country	Name	City	State
United States	University of California Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in VAS	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).	Baseline and 2 weeks
Primary	Change in HAMD-17	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.	Baseline and 2 weeks
Primary	Change in MPQ	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.	Baseline and 2 weeks
Primary	Change in PASS	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).	Baseline and 2 weeks