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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
SUVmax
Secondary outcome measures
Ipsi- and contralateral BAT during SCS-activation

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.

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
973 Previous Clinical Trials
7,385,802 Total Patients Enrolled
Kim Burchiel, MDPrincipal InvestigatorOregon Health and Science University

Media Library

Research electrode (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04326192 — N/A
Type 2 Diabetes Research Study Groups: All subjects
Type 2 Diabetes Clinical Trial 2023: Research electrode Highlights & Side Effects. Trial Name: NCT04326192 — N/A
Research electrode (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04326192 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate headcount of participants in this clinical trial?

"Affirmative. Clinicaltrials.gov records show that this medical experiment was initially posted on February 19th 2021 and recently modified on April 18th 2022. 10 participants need to be enrolled from 1 trial site for successful completion of the research study."

Answered by AI

Are geriatric patients being considered for enrollment in this research endeavor?

"Consistent with the trial's eligibility requirements, applicants must be no younger than 21 and not beyond 70 years of age."

Answered by AI

Is it possible for me to partake in this research endeavor?

"This research study is searching for 10 candidates aged between 21 and 70, who have been diagnosed with type 2 diabetes mellitus. Additional entry requirements necessitate that the participant has chronic neuropathic pain in their legs or back, hasn't previously gone through SCS (spinal cord stimulation) therapy for relief of this kind of pain, and holds a BMI value (calculated as pounds divided by height squared multiplied by 703) between 25 and 45."

Answered by AI

Are there any openings in this clinical trial for potential participants?

"As per clinicaltrials.gov, the trial is seeking participants now and was first posted on February 19th 2021 before being refreshed as recently as April 18th 2022."

Answered by AI

Who else is applying?

What site did they apply to?
Oregon Health & Science University
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

Is there any compensation for this trail?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Brown Adipose Tissue Activation by Spinal Cord Stimulation
Kim J. Burchiel 2021. "Brown Adipose Tissue Activation by Spinal Cord Stimulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04326192.
All > Morbid Obesity > Spinal Cord
~3 spots leftby Oct 2025
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