Brown Adipose Tissue Activation by Spinal Cord Stimulation
NCT ID: NCT04326192
Last Updated: 2024-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2021-02-19
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
21 Years
70 Years
ALL
No
Sponsors
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Oregon Health and Science University
OTHER
Responsible Party
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Kim J. Burchiel
Professor
Principal Investigators
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Kim Burchiel, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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Oregon Health & Science University
Portland, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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Kim Burchiel, MD
Role: primary
Other Identifiers
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STUDY00020197
Identifier Type: -
Identifier Source: org_study_id
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