Spinal Cord Stimulation for Type 2 Diabetes
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Oregon Health and Science University
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?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.
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.
How does spinal cord stimulation treatment differ from other treatments for type 2 diabetes?
Spinal cord stimulation (SCS) is unique because it involves using electrical impulses to improve blood glucose control and reduce insulin needs, which is different from traditional diabetes treatments that typically involve medication or insulin injections. It also shows promise in improving insulin sensitivity and managing chronic pain associated with diabetes.
16789Is spinal cord stimulation generally safe for humans?
Spinal cord stimulation (SCS) is generally considered safe for treating chronic pain, with studies showing its long-term safety and effectiveness. However, there are some risks, such as potential complications during electrode removal and the possibility of nerve injury during implantation, though these are not well-defined in the literature.
12345What data supports the effectiveness of the treatment 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. It has also been effective in improving quality of life and managing pain in diabetic neuropathy, which is a type of nerve damage caused by diabetes.
16789Eligibility Criteria
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.
I am between 21 and 70 years old.
Exclusion Criteria
My BMI is either below 25 or above 45.
I am considered unable to make my own medical decisions.
I am currently taking beta blockers.
I am under 18 years old.
Participant Groups
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.
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.
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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Oregon Health & Science UniversityPortland, OR
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Who is running the clinical trial?
Oregon Health and Science UniversityLead Sponsor
References
Decreased insulin requirements with spinal cord stimulation in a patient with diabetes. [2019]We describe a case of type-2 diabetes mellitus with significant improvement in blood glucose control and significant decrease in insulin requirements after initiation of spinal cord stimulation. We believe that spinal cord stimulation may provide additional beneficial effects in patients with chronic pain and diabetes.
Effect and safety of spinal cord stimulation for treatment of chronic pain caused by diabetic neuropathy. [2011]Spinal cord stimulation (SCS) has been shown effective as a therapy for different chronic painful conditions, but the effectiveness of this treatment for pain as a result of peripheral diabetic neuropathy is not well established. The primary objectives of this study were to evaluate the effect and safety of SCS for treatment of pain and the effects on microcirculatory blood flow in the affected areas in patients with refractory peripheral diabetic neuropathy.
Incidence and avoidance of neurologic complications with paddle type spinal cord stimulation leads. [2022]While reference is frequently made to the risk of spinal cord or nerve root injury with the surgical implantation of paddle type spinal cord stimulation (SCS) electrodes, data are lacking on the frequency, causes, and prevention of these complications.
Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. [2022]Spinal cord stimulation (SCS) is a safe, reversible surgical treatment for complex regional pain syndrome and failed back surgery syndrome refractory to conventional medical management. Paddle electrodes are routinely used for the permanent implant because of the reduced risk of migration, lower energy requirements, and expanded coverage options. The risks associated with paddle lead removal are not well defined in the literature.
Spinal cord stimulation for chronic refractory pain: Long-term effectiveness and safety data from a multicentre registry. [2019]Spinal cord stimulation (SCS) is an established therapy for refractory neuropathic pain. To ascertain the balance between treatment benefits and risks, the French National Authority for Health requested a post-market registry for real-world evaluation of the long-term effectiveness and safety of the therapy.
Influence of Spinal Cord Stimulation on Insulin Sensitivity in Chronic Pain Patients. [2022]This prospective, sham-controlled, randomized, cross-over study (NCT03637075), was designed to test the hypothesis that spinal cord stimulation (SCS) for the treatment of pain can also improve glucose metabolism and insulin sensitivity when compared to sham stimulation.
Clinical Effect Analysis of Spinal Cord Electrical Stimulator Implantation for Diabetic Foot. [2023]To investigate the clinical effect of spinal cord electrical stimulator implantation in the treatment of a diabetic foot (DF).
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. [2023]To evaluate high-frequency (10-kHz) spinal cord stimulation (SCS) treatment in refractory painful diabetic neuropathy.
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. [2023]To evaluate the long-term efficacy of high-frequency (10 kHz) spinal cord stimulation (SCS) for treating refractory painful diabetic neuropathy (PDN).