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临床试验/NCT03587350
NCT03587350已完成不适用

A Single Site, Pilot Study to Assess the Efficacy of a Novel Minimally Invasive Device to Monitor Dystonic Movements in Patients With Cervical Dystonia Receiving Botulinum Toxin Therapy

The Leeds Teaching Hospitals NHS Trust2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年4月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
2
主要终点
Successful monitoring of movement by the shimmer monitor

研究概览

简要总结

The study involves the use of a novel, non-invasive, monitoring device to measure the response to treatment with botulinum toxin injections in 24 (16 Intervention and 8 control) patients with cervical dystonia. A baseline assessment, prior to botulinum treatment,will be structured around validated clinical rating scales for cervical dystonia and questionnaires and the performance of simple neck movements, and will be undertaken while the patient wears a movement sensor attached to the head with an elastic strap. The same assessments will be undertaken at 0, 3, 6, 9 and 12 weeks following treatment to assess response. The patients' treatment will not be affected by their participation in the research. The device readings will then be compared with the clinical ratings to establish whether it might be used as a more sensitive measure of treatment response than clinical assessment alone. This will help clinicians to plan and execute botulinum injections more effectively in future

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female participants aged 18 years or older (no upper age limit) and willing and able to provide informed consent.
  • Participant is able and willing to comply with the follow-up schedule and protocol.
  • Participants diagnosed with cervical dystonia.
  • Participant has previously received botulinum toxin therapy for cervical dystonia without adverse side effects OR is naïve to botulinum toxin therapy but is suitable to participate in the investigator's opinion

排除标准

  • -Participated in another clinical investigation within 30 days.
  • Allergy to device components or botulinum toxin.
  • Medical co-morbidities that preclude botulinum toxin therapy.
  • Patient is incapable of understanding or responding to the study

研究组 & 干预措施

Interventional Treatment

Active Comparator

干预措施: Shimmer monitoring (Device)

Usual care

No Intervention

结局指标

主要结局

Successful monitoring of movement by the shimmer monitor

时间窗: 3, 6, 9 and 12 weeks post botulinum therapy

Accurate assessment of cervical dystonia at different time points to assess change over allocated time frame.

次要结局

未报告次要终点

研究者

发起方
The Leeds Teaching Hospitals NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (2)

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