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Completed

NCT Number: NCT04272411

SCS Stimulation Clamp to Assess Impact of Stimulation on Glucose Metabolism

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hopsital Tübingen

Tübingen, 72076, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sham SCS stimulation

Device

Sham SCS stimulation via implanted neuromodulation device for 45 min during the steady state of a hyperinsulinemic euglycemic clamp.

Tonic SCS stimulation

Device

Tonic SCS stimulation via implanted neuromodulation device for 45 min during the steady state of a hyperinsulinemic euglycemic clamp.

Burst SCS Stimulation

Device

Burst SCS stimulation via implanted neuromodulation device for 45 min during the steady state of a hyperinsulinemic euglycemic clamp.

Primary outcomes

  1. Change in peripheral insulin sensitivity (tonic/burst versus sham stimulation)

    Time frame: 130-150 minutes, 190-210 minutes and 250-270 minutes respectively during euglycemic clamp

    Effect of tonic or burst versus sham SCS stimulation on insulin sensitivity assessed by hyperinsulinemic euglycemic clamp.

Secondary outcomes

  1. Change in peripheral insulin sensitivity (tonic versus burst stimulation)

    Time frame: 130-150 minutes, 190-210 minutes and 250-270 minutes respectively during euglycemic clamp

    Differential effects of tonic versus burst SCS stimulation on insulin sensitivity assessed by hyperinsulinemic euglycemic clamp.

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • Abbott

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Feb 17, 2020
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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