Brown Adipose Tissue Activation by Spinal Cord Stimulation

Overview

The objective of this study is to investigate and utilize spinal cord stimulation (SCS) as an effective approach to eliciting weight loss and potentially alleviating Type 2 diabetes mellitus (DM), as evidenced by increasing metabolism of adipose tissue.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2021

Detailed Description

This research study aims to investigate possible activation of brown adipose tissue (BAT) metabolism by upper thoracic spinal cord stimulation (SCS). We believe that our multidisciplinary research team presents a unique opportunity to test whether SCS can activate BAT metabolism, as tested during a routine screening procedure for spinal cord stimulation (SCS) for pain control. Our marker for BAT activation is 18F-fluorodeoxyglucose (FDG) – positron emission tomography (PET), which has previously been used to gauge cold-evoked BAT activation, and other studies of BAT in humans. We believe this proof-of-concept study could pave the way for a new therapeutic modality for the treatment of morbid obesity, and Type 2 Diabetes Mellitus.

Interventions

  • Device: Research electrode
    • A second electrode will be placed percutaneously by Tuohy needle in the epidural space at the same time as the SCS trial implant; at lateral T1-2 area randomly assigned to the left or right side of the lateral epidural space, at the time of the procedure. Placement of electrodes is not experimental, but the placement of a second electrode is a research-driven procedure.

Arms, Groups and Cohorts

  • Experimental: All subjects
    • All subjects will have two PET/CT scans on days 3 and 5 after SCS electrode implantation: (1) Baseline and (2) SCS-activated. Other than SCS activation, both studies will be conducted under identical conditions. For the first scan, subjects will be randomly assigned to either a baseline (no SCS during PET/CT) or with SCS during PET/CT prior to the day of their first scan. The second scan will complete the sequence with either a baseline or SCS-activated scan, as randomized.

Clinical Trial Outcome Measures

Primary Measures

  • SUVmax
    • Time Frame: 1 week
    • Maximum standardized uptake value (SUVmax) of bilateral cervical and supraclavicular regions during SCS activation, in comparison to baseline imaging

Secondary Measures

  • Ipsi- and contralateral BAT during SCS-activation
    • Time Frame: 1 week
    • A comparison of ipsi- and contralateral BAT during SCS-activation. PET/CT images will be reconstructed as per standard clinical routine.

Participating in This Clinical Trial

Inclusion Criteria

1. Age: 21-70 years

2. Failed back surgery syndrome (FBSS) diagnosis with persistent neuropathic leg and back pain

3. Subjects who are already planning to undergo SCS for FBSS.

4. Subjects with a BMI of 25-45, using formula; weight (lb) / [height (in)] 2 x 703

Exclusion Criteria

1. No FBSS diagnosis

2. Not considering SCS for FBSS

3. Forensic patient

4. Taking beta blockers

5. Weight change > 5% within last 3 months

6. habitual tobacco use

7. habitual excessive alcohol use

8. pregnancy

9. Decisionally impaired adults

10. Prisoners

11. Children

12. Neonates

13. Subjects with BMI of <25 or >45

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Oregon Health and Science University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kim J. Burchiel, Professor – Oregon Health and Science University
  • Overall Official(s)
    • Kim Burchiel, MD, Principal Investigator, Oregon Health and Science University
  • Overall Contact(s)
    • Kim Burchiel, MD, 503-494-4314, burchiek@ohsu.edu

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