Brown Adipose Tissue Activation by Spinal Cord Stimulation
Primary Purpose
Pain, Back, Obesity, Morbid, Type 2 Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Research electrode
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Back focused on measuring Obesity, Diabetes
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
Sites / Locations
- Oregon Health & Science UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All subjects
Arm Description
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.
Outcomes
Primary Outcome Measures
SUVmax
Maximum standardized uptake value (SUVmax) of bilateral cervical and supraclavicular regions during SCS activation, in comparison to baseline imaging
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04326192
First Posted
March 26, 2020
Last Updated
April 18, 2022
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT04326192
Brief Title
Brown Adipose Tissue Activation by Spinal Cord Stimulation
Official Title
Brown Adipose Tissue Activation by Spinal Cord Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 19, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Back, Obesity, Morbid, Type 2 Diabetes
Keywords
Obesity, Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All subjects
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Research electrode
Intervention Description
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 Measure Information:
Title
SUVmax
Description
Maximum standardized uptake value (SUVmax) of bilateral cervical and supraclavicular regions during SCS activation, in comparison to baseline imaging
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Ipsi- and contralateral BAT during SCS-activation
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kim Burchiel, MD
Phone
503-494-4314
Email
burchiek@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Burchiel, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Burchiel, MD
Phone
503-494-4314
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Brown Adipose Tissue Activation by Spinal Cord Stimulation
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