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临床试验/NCT04272411
NCT04272411已完成不适用

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

University Hospital Tuebingen2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年7月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Change in peripheral insulin sensitivity (tonic/burst versus sham stimulation)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Change in peripheral insulin sensitivity (tonic versus burst stimulation)(130-150 minutes, 190-210 minutes and 250-270 minutes respectively during euglycemic clamp)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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