Spinal Cord Stimulation for Type 2 Diabetes

Overseen By Kim Burchiel, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Must not be taking: Beta blockers

Disqualifiers: Tobacco, Alcohol, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 week

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether spinal cord stimulation (SCS) can aid weight loss and improve Type 2 diabetes by enhancing fat metabolism. Participants will have a small device placed near their spine to assess its impact on fat burning. Suitable candidates include those with ongoing leg and back pain, who are already planning to receive SCS for pain, and have a BMI (body mass index) between 25 and 45.

As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to innovative treatments for weight loss and diabetes management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking beta blockers.

What prior data suggests that spinal cord stimulation is safe for Type 2 diabetes?

Research shows that spinal cord stimulation (SCS) is generally safe for patients. Studies have found that SCS is well-tolerated for conditions like diabetic neuropathy, where diabetes causes nerve pain. For instance, some studies provide moderate-quality evidence that SCS is safe for managing pain in these cases.

In everyday situations, high-frequency SCS is considered a safe option for those with painful diabetic neuropathy, which results from nerve damage due to diabetes. Another study confirmed that a specific type of SCS, called 10 kHz SCS, was safe and effective for treating this pain.

While these findings mainly focus on SCS for pain relief, they offer reassurance about its safety. However, since this trial explores SCS for weight loss and diabetes management, this represents a new approach. Although past evidence supports SCS's safety in similar situations, ongoing research will help clarify its safety for these new uses. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard insulin therapy and oral medications used for type 2 diabetes, spinal cord stimulation (SCS) offers a novel approach by targeting the nervous system to potentially improve glucose metabolism. Researchers are excited about this treatment because it uses a research electrode to activate specific neural pathways, which could lead to better regulation of blood sugar levels. This method could offer a new avenue for managing diabetes, especially for patients who have difficulty controlling their condition with conventional treatments.

What evidence suggests that spinal cord stimulation is effective for Type 2 diabetes?

Research has shown that spinal cord stimulation (SCS) could effectively manage type 2 diabetes. Studies have found that SCS might help control blood sugar levels and reduce insulin needs in people with type 2 diabetes. SCS also effectively treats painful diabetic nerve damage, a common complication of diabetes. This trial will investigate the effects of SCS on participants, with all subjects undergoing two PET/CT scans to assess the impact of SCS activation. While more research is needed, early results are encouraging for those considering this treatment. ^{2 3 4 6 7}

Who Is on the Research Team?

Kim Burchiel, MD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I have ongoing nerve pain in my leg and back.

I have never tried a spinal cord stimulator for pain.

Exclusion Criteria

I am not considering a spinal cord stimulator for pain management.

You drink too much alcohol regularly.

My BMI is either below 25 or above 45.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo spinal cord stimulation (SCS) and PET/CT scans to assess brown adipose tissue activation

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Research electrode

Trial Overview 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.

How Is the Trial Designed?

Group I: All subjects Experimental Treatment 1 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.

Research electrode is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Spinal Cord Stimulation for:

• Chronic pain management
• Failed back syndrome
• Complex regional pain syndrome

Approved in European Union as Spinal Cord Stimulation for:

• Chronic pain management
• Failed back syndrome
• Complex regional pain syndrome
• Angina pectoris

Approved in Canada as Spinal Cord Stimulation for:

• Chronic pain management
• Failed back syndrome
• Complex regional pain syndrome

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Published Research Related to This Trial

In a study of 11 diabetic patients with chronic lower limb pain who did not respond to conventional treatments, spinal cord stimulation (SCS) provided significant pain relief, with average pain scores dropping from 77 to 34 over 6 months.

Eight out of nine patients continued to experience substantial pain relief at the end of the study, allowing many to reduce their pain medication, indicating that SCS is an effective and safe therapy for chronic diabetic neuropathic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect and safety of spinal cord stimulation for treatment of chronic pain caused by diabetic neuropathy. de Vos, CC., Rajan, V., Steenbergen, W., et al.[2011]

In a study of 402 patients with chronic pain who received spinal cord stimulation (SCS) devices, 55% of those with lower limb pain and 67% with upper limb pain reported a significant reduction in pain (≥50% reduction) after 2 years, indicating the long-term effectiveness of SCS.

The majority of patients (91%) were satisfied with their treatment, and 93% would choose to undergo the procedure again, while also showing a significant decrease in the need for pain medications, highlighting both the efficacy and safety of SCS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic refractory pain: Long-term effectiveness and safety data from a multicentre registry. Brinzeu, A., Cuny, E., Fontaine, D., et al.[2019]

A case study showed that spinal cord stimulation led to significant improvements in blood glucose control and reduced insulin needs in a patient with type-2 diabetes mellitus.

This suggests that spinal cord stimulation could offer additional benefits for glycemic control in patients with chronic pain and diabetes, beyond its primary use for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreased insulin requirements with spinal cord stimulation in a patient with diabetes. Kapural, L., Hayek, SM., Stanton-Hicks, M., et al.[2019]

In a study of 216 patients with refractory painful diabetic neuropathy, 10 kHz spinal cord stimulation (SCS) led to a remarkable 79.9% reduction in pain over 24 months, with 90.1% of participants achieving at least 50% pain relief.

The treatment also significantly improved health-related quality of life and sleep, with 65.7% of participants showing clinically meaningful neurological improvements, indicating that 10 kHz SCS is both safe and effective for long-term management of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term efficacy of high-frequency (10 kHz) spinal cord stimulation for the treatment of painful diabetic neuropathy: 24-Month results of a randomized controlled trial. Petersen, EA., Stauss, TG., Scowcroft, JA., et al.[2023]

The risk of neurologic injury from the surgical implantation of paddle type spinal cord stimulation electrodes is low, estimated at below 0.6%, based on primary data analysis.

Despite the rarity of these complications, the study emphasizes the importance of implementing preoperative, intraoperative, and postoperative measures to further minimize risks and improve procedural safety, along with careful patient follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and avoidance of neurologic complications with paddle type spinal cord stimulation leads. Levy, R., Henderson, J., Slavin, K., et al.[2022]

In a multicenter randomized controlled trial involving 216 participants with refractory painful diabetic neuropathy, 10-kHz spinal cord stimulation (SCS) combined with conventional medical management led to a significant mean pain relief of 74.3% after 12 months, with 85% of participants experiencing at least 50% pain relief.

The treatment also resulted in substantial improvements in health-related quality of life, with 92% of participants reporting satisfaction with the 10-kHz SCS, indicating its effectiveness and durability as a treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Frequency 10-kHz Spinal Cord Stimulation Improves Health-Related Quality of Life in Patients With Refractory Painful Diabetic Neuropathy: 12-Month Results From a Randomized Controlled Trial. Petersen, EA., Stauss, TG., Scowcroft, JA., et al.[2023]

In a study involving 10 non-diabetic participants with chronic neuropathic pain, tonic spinal cord stimulation (SCS) significantly improved insulin sensitivity compared to sham stimulation, suggesting a potential metabolic benefit of SCS beyond pain relief.

BurstDR stimulation did not show a significant improvement in insulin sensitivity compared to sham, indicating that not all SCS methods may have the same metabolic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of Spinal Cord Stimulation on Insulin Sensitivity in Chronic Pain Patients. Morgalla, MH., Fritschle, H., Vosseler, A., et al.[2022]

In a study of 19 patients with diabetic foot, spinal cord electrical stimulator implantation significantly reduced pain levels and improved quality of life, as indicated by lower visual analog scale scores and higher QOL scores post-surgery.

The procedure also enhanced nerve conduction velocities and increased blood flow to the lower limbs, achieving a high limb salvage rate of 94.74%, suggesting it is an effective treatment option for preventing toe amputation in diabetic foot patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Effect Analysis of Spinal Cord Electrical Stimulator Implantation for Diabetic Foot. Zhou, PB., Bao, M.[2023]

In a study of 68 patients who had spinal cord stimulation paddle electrodes removed, the most common reason for removal was loss of coverage or effect (75%), indicating that while SCS is effective, it may not always provide lasting relief.

Postoperative complications occurred in 11.75% of patients, with two major complications requiring reoperation, highlighting that while SCS removal is generally safe, it does carry some risks that patients should be aware of.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. Maldonado-Naranjo, AL., Frizon, LA., Sabharwal, NC., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12004347/

Long‐term efficacy of 10 kHz spinal cord stimulation in ... Our survey captured patient‐reported outcomes at a median of 4.1 years after implantation of a permanent 10 kHz SCS system.

2. sciencedirect.com sciencedirect.com/science/article/pii/S016882272300517X

Real world outcomes with spinal cord stimulation High frequency spinal cord stimulation (SCS) is a safe and effective treatment option for refractory painful diabetic neuropathy.

3. withpower.com withpower.com/trial/phase-back-pain-1-2021-52a53

Spinal Cord Stimulation for Type 2 Diabetes Research shows that spinal cord stimulation can help improve blood sugar control and reduce insulin needs in people with type 2 diabetes.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8586096/

Spinal Cord Stimulation for Painful Diabetic Peripheral ... Spinal cord stimulation has been proposed as an alternative therapy for treatment of painful diabetic neuropathy of the lower extremities.

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P010032S189B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) ... Spinal Cord Stimulation Outcome in Painful Diabetic. Peripheral Neuropathy: Five-Year Follow-up of a Prospective T w o-Center Clinical Trial. Diabetes Care.

6. diabetesjournals.org diabetesjournals.org/care/article/37/11/3016/29087/Spinal-Cord-Stimulation-and-Pain-Relief-in-Painful

Spinal Cord Stimulation and Pain Relief in Painful Diabetic ... Outcome Measurements. Basic demographic data and PDPN history were obtained, including duration of DM, duration of painful symptoms, type of DM, ...

7. diabetesresearchclinicalpractice.com diabetesresearchclinicalpractice.com/article/S0168-8227(23)00523-5/fulltext

Spinal cord stimulation in painful diabetic neuropathy As was shown in a randomized controlled trial, SENZA-PDN (NCT03228420), 10 kHz SCS is safe and effective for the treatment of painful diabetic neuropathy. 10 ...