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临床试验/NCT01859247
NCT01859247已完成不适用

Identification of Optimal Stimulation Site for Cervical Dystonia Symptoms: An Exploratory Study

University of New Mexico2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)

研究概览

简要总结

The overall objective of this application is to therapeutically target the dysfunctional premotor-motor interaction in dystonia-and to provide a focused treatment of specific anatomical networks in order to reduce side effects and to improve symptom control over conventional therapies.

详细描述

We propose using repetitive transcranial magnetic stimulation (rTMS) over distinct premotor areas in patients with cervical dystonia (CD) with the goal of improving symptoms and reducing unwanted side effects. The knowledge gained in this proposed research will identify a specific premotor area to be targeted with rTMS that is expected to result in a novel intervention that could enhance or replace current treatments for CD. rTMS could be included as an adjunct treatment to botulinum toxin that could sustain treatment effect and decrease the frequency of re-injection, potentially resulting in cost savings without a decrease in symptom control. In addition to medical cost reduction, improved quality of life could be expected with the successful development of therapies that extend dystonia symptom control. rTMs has been FDA-approved for the treatment of depression and our proposal uses an even lower stimulation rate, suggesting continued use within clearly safe parameters. Successful completion of this research could lead to rapid adoption of this therapeutic modality.

We will test the hypothesis that rTMS of a distinct premotor site will provide more effective treatment of CD than non-specific activation of the entire premotor region. This will be done by performing a randomized, observer-blinded exploratory pilot study to determine the optimal site of rTMS over various sites of the premotor and motor cortex to improve the symptoms of cervical dystonia. Completion of this aim should lead to development of targeted TMS therapy for CD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

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

  • Clinical diagnosis of idiopathic cervical dystonia
  • Age 18 years or older
  • Normal findings in the medical history, physical and neurological examination, except for dystonia
  • Last treatment with botulinum toxin more than two months ago

排除标准

  • History of seizure disorder
  • Pregnancy- a pregnancy test will be performed for women of childbearing potential
  • History of any other neurological disorders or conditions requiring the use of anti-depressants that are known to increase seizure threshold, neuroleptic medication, anticholinergic drugs and muscle relaxants
  • History of neuroleptic medications/ prior use of neuroleptics

结局指标

主要结局

Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)

时间窗: Change from baseline pre-intervention TWSTRS score to post-intervention within 1 hour of treatment

Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) was used to assess severity of disease. The score for this section ranges from 0 (absence of severity) to 35 (maximum severity).

次要结局

  • Dorsal Premotor-motor Inhibition (dPMI)(Change from baseline dPMI to post-intervention within 1 hour of treatment)
  • Composite Measure of Patient Rating of Symptoms and Tolerability(Assessment completed immediately after rTMS treatment session)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah Pirio Richardson

MD

University of New Mexico

研究点 (2)

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