Brown Adipose Tissue Activation by Spinal Cord Stimulation

Oregon Health and Science University10 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain, Back Obesity, Morbid Type 2 Diabetes

Interventions

Research electrodeDEVICE

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age: 21-70 years 2. Persistent neuropathic leg and back pain 3. Subjects who are already planning to undergo SCS for pain 4. Subjects who have not received a prior SCS trial for pain 5. Subjects with a BMI of 25-45, using formula; weight (lb) / \[height (in)\]2 x 703 Exclusion Criteria: 1. Not considering SCS for pain 2. Forensic patient 3. Taking beta blockers 4. Weight change \> 5% within last 3 months 5. Habitual tobacco use 6. Habitual excessive alcohol use 7. Pregnancy 8. Decisionally impaired adults 9. Children 10. Neonates 11. Subjects with a BMI of \<25 or \>45

Locations (1)

Oregon Health & Science University

Portland, Oregon, United States

RECRUITING

Outcomes

Primary Outcomes

SUVmax

Maximum standardized uptake value (SUVmax) of bilateral cervical and supraclavicular regions during SCS activation, in comparison to baseline imaging

Time frame: 1 week

Secondary Outcomes

Ipsi- and contralateral BAT during SCS-activation

A comparison of ipsi- and contralateral BAT during SCS-activation. PET/CT images will be reconstructed as per standard clinical routine.

Time frame: 1 week

Central Contacts

Kim Burchiel, MD

CONTACT

503-494-4314 burchiek@ohsu.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.