Brown Adipose Tissue Activation by Spinal Cord Stimulation

Part of paid clinical trials in Portland, Oregon.

Sponsor: Oregon Health and Science University
Study ID: NCT04326192
Status: Recruiting

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Conditions

Eligibility Criteria

Sex: ALL
Age: 21 Years - 70 Years
Healthy Volunteers: Not accepted

Interventions

Research electrode — DEVICE
An additional research 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 an additional electrode is a research-driven procedure.

Study Details

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.

Key Dates

First listed: Mar 30, 2020
Start date: Feb 19, 2021
Status verified: Aug 2026
Primary completion: Dec 31, 2028
Completion: Dec 31, 2029

Study Design

Enrollment: 10 participants (estimated)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

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.