Brown Adipose Tissue Activation by Spinal Cord Stimulation

NCT04326192 | Recruiting DMC FDA Device

• 1 other identifier: STUDY00020197
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Back; Obesity, Morbid; Type 2 Diabetes

Keywords

Obesity; Diabetes

Outcome Measures

Primary Outcomes (1)

• SUVmax

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

  1 week

Secondary Outcomes (1)

• Ipsi- and contralateral BAT during SCS-activation

  1 week

Study Arms (1)

All subjects

EXPERIMENTAL

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

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.

All subjects

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Back Pain; Obesity, Morbid; Diabetes Mellitus, Type 2; Obesity; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kim Burchiel, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kim Burchiel, MD

CONTACT

503-494-4314; burchiek@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 30, 2020
• Study Start: February 19, 2021
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)