Brown Adipose Tissue Activation by Spinal Cord Stimulation

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.

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.

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.

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

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

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