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临床试验/ISRCTN10416636
ISRCTN10416636进行中(未招募)2 期

Closed-Loop Electronic stimulation - Mechanomyogram sensor system for Passive tremor Suppression treatment (CLEMPTS)

St George’s University Hospitals NHS Foundation Trust0 个研究点目标入组 20 人开始时间: 2023年4月14日最近更新:
适应症

试验速览

阶段
2 期
状态
进行中(未招募)
发起方
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Adults aged over 18 years
  • 2. Diagnosed with essential tremor or Parkinson's related tremor by a neurologist with expertise in movement disorders
  • 3. Functional disability due to tremor reported by patient or clinician
  • 4. Willing and able to give informed consent

排除标准

  • 1. Cognitive impairment (judged by the clinician on the care team or in the research team as a participant not having sufficient mental capacity to understand the study and its requirements). This includes anyone who, in the opinion of clinicians on the care team or clinicians in the research team, is unlikely to retain sufficient mental capacity for the duration of their involvement in the study.
  • 2. Subject has a severe medical or psychiatric illness that would interfere with completing initial and follow-up assessments
  • 3. Participation in concurrent research which involves a novel therapeutic IMP or device
  • 4. Although the device is not expected to interfere with pregnancy, women who are pregnant would not be eligible to take part
  • 5. Active treatment with an implantable stimulation device (such as a cardiac pacemaker or deep brain stimulation implantable programmable generator)
  • 6. Allergies to neoprene, mylar, electrode hydrogel or medical tape

研究者

发起方
St George’s University Hospitals NHS Foundation Trust

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