Brown Adipose Tissue Activation by Spinal Cord Stimulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Research electrode.
- Who it may be relevant to
- Registry conditions: Pain, Back, Obesity, Morbid, Type 2 Diabetes. Basic parameters: 21 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
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.
Primary outcome measures
- SUVmax [Time frame: 1 week]
Secondary outcome measures (1)
- Ipsi- and contralateral BAT during SCS-activation [Time frame: 1 week]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Oregon Health & Science University — Portland
Identifiers
NCT: NCT04326192 · STUDY00020197