SCS Stimulation Clamp to Assess Impact of Stimulation on Glucose Metabolism

NCT ID: NCT04272411

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-11
• Study Completion Date: 2020-06-01

Brief Summary

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.

Conditions

Spinal Cord Stimulation (SCS); Blood Glucose Metabolism; Euglycemic Hyperinsulinemic Clamp

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Sham SCS stimulation

Sham SCS stimulation via implanted neuromodulation device

Group Type: SHAM_COMPARATOR

Sham SCS stimulation

Intervention Type: DEVICE

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

Tonic SCS stimulation

Tonic SCS stimulation via implanted neuromodulation device

Group Type: ACTIVE_COMPARATOR

Tonic SCS stimulation

Intervention Type: DEVICE

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

Burst SCS Stimulation

Burst SCS stimulation via implanted neuromodulation device

Group Type: ACTIVE_COMPARATOR

Burst SCS Stimulation

Intervention Type: DEVICE

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

Interventions

Sham SCS stimulation

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

Intervention Type: DEVICE

Tonic SCS stimulation

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

Intervention Type: DEVICE

Burst SCS Stimulation

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hopsital Tübingen

Tübingen, , Germany

Countries

Germany

Other Identifiers

202/2019BO2

Identifier Type: -

Identifier Source: org_study_id