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RecruitingNCT04326192Updated Aug 25, 2026

Brown Adipose Tissue Activation by Spinal Cord Stimulation

An interventional study of Research electrode in Pain, Back, Obesity, Morbid and Type 2 Diabetes, sponsored by Oregon Health and Science University. Recruiting at 1 site in United States. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2021; still recruiting 5 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
21 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pain, Back
  • Obesity, Morbid
  • Type 2 Diabetes

Keywords

  • Obesity
  • Diabetes
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's planned enrollment of 10 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study 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.

    Device: Research electrode

Interventions

  • DeviceResearch electrode

    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.

06

What researchers measure

Primary outcomes

  1. SUVmax

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

    Time frame: 1 week

Secondary outcomes

  1. Ipsi- and contralateral BAT during SCS-activation

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

    Time frame: 1 week

07

Study locations

1 of 1 sites recruiting
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
    • Kim Burchiel, MD · Contact · 503-494-4314
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04326192
Lead sponsor
Oregon Health and Science University
Responsible party
Kim J. Burchiel (Professor, Oregon Health and Science University) — Principal investigator
First posted
Mar 30, 2020
Start date
Feb 19, 2021
Primary completion
Dec 2028 (estimated)
Completion
Dec 2029 (estimated)
Last update
Aug 25, 2026

Study contacts

Kim Burchiel, MD
Contact
burchiek@ohsu.edu
503-494-4314
Kim Burchiel, MD
principal investigator · Oregon Health and Science University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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