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临床试验/NCT02333695
NCT02333695Unknown不适用

Medical Device for Magnetic Therapy for Spinal Cord Injuries (SCIMAG)

American Society Of Thermalism And Climatology Inc2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Reduction Hiperrelexia

研究概览

简要总结

A medical device for magnetic therapy for spinal cord injuries (SCI) will be disclosed. The apparatus comprises a combination of several magnets enclosed in a supportive cover. The magnets are placed in a proper position and their polarity can be changed at any time without any difficulty.

详细描述

A medical device for magnetic therapy for spinal cord injuries (SCI) will be disclosed. The apparatus comprises a combination of several magnets enclosed in a supportive cover. The magnets are placed in a proper position and their polarity can be changed at any time without any difficulty.

The device provides a source of stimulation for the nerve to achieve therapeutic results and rehabilitation of patients with spinal trauma or stroke.

A spinal cord injury - damage to any part of the spinal cord or nerves at the end of the spinal canal - often causes permanent changes in strength, sensation and other body functions below the site of the injury.

Many scientists are optimistic that advances in research will someday make the repair of spinal cord injuries possible. Research studies are ongoing around the world. In the meantime, treatments and rehabilitation allow many people with a spinal cord injury to lead productive, independent lives.

The effects of SCI depend on the type of injury and the level of the injury. SCI can be divided into two types of injury - complete and incomplete.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • informed consent;
  • persons with confirmed and verified lesion of the central nervous system

排除标准

  • Identification of the study a total intolerance to a pulsed magnetic field;
  • Development after inclusion of acute myocardial infarction and acute ischemic;
  • Installation of the pacemaker, intracardiac catheters or operations on the brain, requiring the abandonment of metal objects in the cranial cavity;
  • Pregnancy;
  • Enhancement of the patient, which requires the maintenance of vital functions by hardware (mechanical ventilation, continuous application infusomats);
  • The emergence of an epileptic seizure ;
  • Failure of the patient to continue participation in the study;

结局指标

主要结局

Reduction Hiperrelexia

时间窗: 30 days

次要结局

  • Stimulate an erection(45 days)
  • Stimulate bowel movements(30 days)
  • Stimulate bladder emptying(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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