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临床试验/NCT01759745
NCT01759745撤回不适用

The Influence of Gaze Shift and Emotions on Symptoms of Blepharospasm- a Pilot Study.

Kirsten Elwischger, MD1 个研究点 分布在 1 个国家开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Duration and frequency of pupillary occlusion

研究概览

简要总结

Blepharospasm (BEB) is a focal dystonia characterized by forceful, involuntary contractions of the orbicularis oculi muscle. (Jankovic et al 1983) Patients with BEB report task and situation specific modulations of their symptoms. So called "sensory tricks" are actions that minimize symptoms and include concentrating, talking, pulling on the eyelids, blowing air, and applying pressure to the periocular or temple region. (Weiner 1984) Many patients describe that other tasks/situations are exacerbate their symptoms specifically under bright fluorescent lights and stress. (Burke 1984) Earlier studies showed that blink patterns differ between BEB patients and control during rest, reading and talking.

In healthy subjects gaze evoked blinks are a physiologic phenomenon: initiation of gaze shifts evoke a blink, blinks facilitate gaze shifts. (Evinger 1994) In healthy subjects emotions and thoughts influence gaze shifts and blink rate. (Leal 2008, de Genaro 1988) However, little is known about various task and emotion specific influences on symptoms of BEB (e.g. expecting a gaze shift might worsen symptoms while driving a car).

Differences in emotion and gaze related blink patterns between patients and controls will contribute to the understanding of the pathophysiology of BEB. This might offer new therapeutic options, e.g. symptom modulation.

The investigators hypothesize that blink patterns, measured by duration and frequency of pupillary occlusion differ between patients and control, when performing gaze shifts and emotion related blink patterns, measured by duration and frequency of pupillary occlusion differ between patients and controls.

The aim of this pilot trial is to assess differences in gaze evoked and emotion related blink patterns between patients and controls. These differences might contribute to the understanding of the pathophysiology of BEB.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Willing to participate
  • Idiopathic blepharospasm
  • Age 18-80
  • Last botulinum toxin injection <3months
  • Willing to participate
  • Age and sex matched with patients

排除标准

  • Secondary blepharospasm
  • Neurologic Comorbidities
  • Other eye disease besides BEB
  • History of neuroleptic medication
  • Use of medications on the study day, that influence eye blinks& attention
  • Drinking of caffeine or theine containing beverages on the study day
  • Patients and Control:
  • Intake of psychotropic drugs at day of examination
  • History of neuroleptic medication
  • present eye disease
  • Neurologic diseases that influence blinking
  • Use of medications on the study day, that influence eye blinks& attention
  • Drinking of caffeine or theine containing beverages on the study day

结局指标

主要结局

Duration and frequency of pupillary occlusion

时间窗: At baseline

Duration and frequency of pupillary occlusion during different tasks and situations will be studied via videooculography

次要结局

  • Number of blinks and spasms.(At baseline)

研究者

发起方
Kirsten Elwischger, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kirsten Elwischger, MD

Dr. Kirsten Elwischger

Medical University of Vienna

研究点 (1)

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