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NCT Number: NCT04326192

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.

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Key information

Conditions

Pain, Back Back Pain Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location status: Recruiting

Location contact

Kim Burchiel, MD

CONTACT

503-494-4314

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Research electrode

Device

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 outcomes

  1. SUVmax

    Time frame: 1 week

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

Secondary outcomes

  1. Ipsi- and contralateral BAT during SCS-activation

    Time frame: 1 week

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

Study contacts

Contact information is provided by the study sponsor or research team.

Kim Burchiel, MD

CONTACT

[email protected]

503-494-4314

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Mar 30, 2020
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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