Recruiting

Spinal Cord Stimulation

Sponsor:

Oregon Health and Science University

Code:

NCT04326192

Conditions

Pain, Back

Obesity, Morbid

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

Interventions

Research electrode

Study Details

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

Study ID

NCT04326192

Start date

Feb 19, 2021

Status verified date

Aug, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age: 21-70 years
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:

1. Not considering SCS for pain
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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Research electrode

An 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.

Primary outcome measure

  • SUVmax [ Time Frame: 1 week ]

Central Contacts and Locations

Central contacts

Kim Burchiel, MD

503-494-4314burchiek@ohsu.edu

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Kim Burchiel, MD

503-494-4314

More Information

Sponsor

Oregon Health and Science University

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

  • Obesity
  • Diabetes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2026-08-25.