RecruitingNot ApplicableNCT04326192

Brown Adipose Tissue Activation by Spinal Cord Stimulation

Sponsor

Oregon Health and Science University

Enrollment

10 participants

Start Date

Feb 19, 2021

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes Obesity, Morbid Pain, Back

Summary

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.

Eligibility

Min Age: 21 YearsMax Age: 70 Years

Inclusion Criteria5

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 Criteria11

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

Interventions

DEVICEResearch 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.