Clinical trial

Brown Adipose Tissue Activation by Spinal Cord Stimulation

Recruiting now · Not applicable · 1 countries · Registry ID NCT04326192

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age21 Years to 70 Years
SexAll
Healthy volunteersNot accepted
ConditionPain, Back, Obesity, Morbid, Type 2 Diabetes

Full registry criteria

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

Treatments and study arms

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.

Primary outcomes

SUVmax1 week

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Oregon Health & Science University🇺🇸 Portland, Oregon, United States
Kim Burchiel, MDContact