Brown Adipose Tissue Activation by Spinal Cord Stimulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-70
SponsorOregon Health and Science University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Not considering SCS for pain
Forensic patient
Taking beta blockers
Weight change > 5% within last 3 months
Trial design
Design model
Single group
Treatments tested in this trial
Research electrode
DeviceAn 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: All subjectsExperimental treatment 1 intervention
Trial outcomes
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 weekSecondary 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 weekSponsors and contacts
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Source ClinicalTrials.gov