Completed

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

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What is being tested

Sham SCS stimulation

+ Tonic SCS stimulation

+ Burst SCS Stimulation

Device
Who is being recruted

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Placebo-Controlled
Interventional
Study Start: July 2019
See protocol details

Summary

Principal SponsorUniversity Hospital Tuebingen
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 11, 2019

Actual date on which the first participant was enrolled.

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.

Official TitleEffects of Burst and Tonic Spinal Cord Stimulation (SCS) in Chronic Neuropathic Pain on Blood Glucose Levels
NCT04272411
Principal SponsorUniversity Hospital Tuebingen
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
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

5 exclusion criteria prevent from participating
diabetes mellitus

Acute diseases such as infections (e.g.) within the last four weeks

Hb < 13 g/dl

anamnestic heparin-induced thrombocytopenia

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Sham
Sham SCS stimulation via implanted neuromodulation device

Group II

Active Comparator
Tonic SCS stimulation via implanted neuromodulation device

Group III

Active Comparator
Burst SCS stimulation via implanted neuromodulation device

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University Hopsital Tübingen

Tübingen, GermanyOpen University Hopsital Tübingen in Google Maps
CompletedOne Study Center