SCS Stimulation Clamp to Assess Impact of Stimulation on Glucose Metabolism

Effects of Burst and Tonic Spinal Cord Stimulation (SCS) in Chronic Neuropathic Pain on Blood Glucose Levels

In 1967 spinal cord stimulation (SCS) for the treatment of chronic neuropathic pain was established. Today various pain syndromes like the failed back surgery syndrome (FBSS), the complex regional pain syndrome (CRPS), ischemic pain or phantom limb pain are treated with SCS. The development of this technique based on the so called "Gate Control Theory" which states that stimulation of the mechanosensitive Aβ fibers suppresses the transmission of pain stimuli via the pain-sensitive C fibers to the brain in the spinal cord. Conventional SCS consists of periodically emitted tonic stimuli with a frequency between 30 and 120 Hz. During implantation, the electrodes are placed in the epidural space in such a way that the paraesthesia caused by nerve stimulation covers the painful area (dermatome), thus relieving the pain. In 2010 de Ridder et al. published an article presenting the so called "Burst Stimulation" where series of high-frequency impulses are released at defined time intervals (frequency: 40 Hz with peaks of 500 Hz per volley). Compared to the tonic SCS the burst technique is more effective and in most cases no paraesthesia is reported. However, potential effects of SCS stimulation on other organ systems have only been insufficiently examined.Especially possible effects of SCS on the glucose metabolism has not been investigated so far. However, it is important to investigate a possible effect for two reasons: SCS could cause severe hypoglycemia which must be avoided. Furthermore, if SCS affects blood sugar levels, it is also of interest what mechanisms are involved and how this knowledge can be used to control elevated blood glucose levels.

The present study is a pilot. The investigators want to examine possible effects of SCS therapy on blood glucose metabolism. Therefore hyperinsulinemic euglycemic clamps with an insulin infusion of 1mU / kg body weight per minute are performed. During the clamp the investigators apply different SCS techniques in a randomly order. Insulinsensitivity is determined at different time points.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Stimulation (SCS); Blood Glucose Metabolism; Euglycemic Hyperinsulinemic Clamp
• Intervention / Treatment: Device: Sham SCS stimulation; Device: Tonic SCS stimulation; Device: Burst SCS Stimulation

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Tübingen, Germany, 72076
    • University Hopsital Tübingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.
• HbA1c < 6,0%
• state after implantation of an neuromodulation device
• Clinical routine blood parameters within the normal ranges

Exclusion Criteria:

• diabetes mellitus
• Acute diseases such as infections (e.g.) within the last four weeks
• Hb < 13 g/dl
• anamnestic heparin-induced thrombocytopenia
• any neurologic or psychiatric disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham SCS stimulation; Sham SCS stimulation via implanted neuromodulation device	Device: Sham SCS stimulation; Sham SCS stimulation via implanted neuromodulation device for 45 min during the steady state of a hyperinsulinemic euglycemic clamp.
Active Comparator: Tonic SCS stimulation; Tonic SCS stimulation via implanted neuromodulation device	Device: Tonic SCS stimulation; Tonic SCS stimulation via implanted neuromodulation device for 45 min during the steady state of a hyperinsulinemic euglycemic clamp.
Active Comparator: Burst SCS Stimulation; Burst SCS stimulation via implanted neuromodulation device	Device: Burst SCS Stimulation; Burst SCS stimulation via implanted neuromodulation device for 45 min during the steady state of a hyperinsulinemic euglycemic clamp.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in peripheral insulin sensitivity (tonic/burst versus sham stimulation)	Effect of tonic or burst versus sham SCS stimulation on insulin sensitivity assessed by hyperinsulinemic euglycemic clamp.	130-150 minutes, 190-210 minutes and 250-270 minutes respectively during euglycemic clamp

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in peripheral insulin sensitivity (tonic versus burst stimulation)	Differential effects of tonic versus burst SCS stimulation on insulin sensitivity assessed by hyperinsulinemic euglycemic clamp.	130-150 minutes, 190-210 minutes and 250-270 minutes respectively during euglycemic clamp

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Collaborators: Abbott

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2019
• Primary Completion (Actual): November 11, 2019
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 202/2019BO2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No