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Device

Spinal Cord Stimulation for Type 2 Diabetes

N/A

Recruiting

Led By Kim Burchiel, MD

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects who are already planning to undergo SCS for pain

Persistent neuropathic leg and back pain

Must not have

Subjects with a BMI of <25 or >45

Decisionally impaired adults

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate whether or not SCS can help with weight loss and diabetes.

Who is the study for?

This trial is for adults aged 21-70 with persistent neuropathic leg and back pain who are planning to get spinal cord stimulation (SCS) for pain relief. They should not have tried SCS before, have a BMI between 25-45, and haven't had significant weight changes recently. Excluded are pregnant individuals, tobacco or excessive alcohol users, those on beta blockers, or anyone outside the BMI range.

What is being tested?

The study aims to see if using spinal cord stimulation can help with weight loss and improve Type 2 diabetes by boosting metabolism in fat tissue. Participants will receive an experimental research electrode during their planned SCS procedure.

What are the potential side effects?

Potential side effects may include discomfort at the electrode site, possible infection risk from the procedure, changes in sensation due to nerve stimulation, and any typical risks associated with surgical procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am planning to get a spinal cord stimulator for pain.

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I have ongoing nerve pain in my leg and back.

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I have never tried a spinal cord stimulator for pain.

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I am between 21 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My BMI is either below 25 or above 45.

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I am considered unable to make my own medical decisions.

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I am currently taking beta blockers.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

SUVmax

Secondary study objectives

Ipsi- and contralateral BAT during SCS-activation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: All subjectsExperimental Treatment1 Intervention

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.

0 / 8Eligibility criteria met