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临床试验/NCT01395264
NCT01395264终止不适用

Saccadometry in Primary Headache Syndromes

Tim Young2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
42
试验地点
2
主要终点
To see if Saccadometry results differ between controls and migraine subjects

研究概览

简要总结

Migraine is one of the commonest neurological disorders, affecting up to 12% of the general population, but remains relatively under-diagnosed and under-treated. Migraine has a wide socioeconomic impact and brings a large economic burden; estimates suggest that disability due to migraine costs > €27 billion per annum across Europe. Despite its prevalence and impact, migraine pathophysiology is poorly understood. A wider understanding of the functional changes in this disorder would be beneficial to both diagnosis and treatment.

Saccades are the rapid eye movements we make when moving the eyes to a new object in our visual field. Reaction time studies have been used to investigate Huntington's disease and Parkinson's disease with great success. These use saccadic tasks (monitoring eye movements). Even at rest we make approximately three saccades per second, so a lot of data can quickly be gathered with non-invasive testing. We hope to understand more of the underlying mechanisms of migraine by studying reaction time in migraine patients.

Our previous pilot study, with less stringent inclusion and exclusion criteria, looked at fewer patients (32 migraineurs and 32 controls), and found that migraineurs showed significantly different saccadic patterns to non-migraineurs.

This study firstly seeks to corroborate the saccadometric findings of our earlier pilot study in a group of migraineurs, and secondly to explore the specificity of these findings in migraine by also studying patients with another primary headache syndrome, namely cluster headache.

Migraine is known to be a dynamic disorder, with previous studies showing longitudinal changes in the migraine brain. To explore this further we hope to record longitudinally (Every day for 21 days) in a small subset of migraineurs to identify potential longitudinal changes in saccadic reaction time. Because of the portability of the equipment this could be done in the subjects own home if they preferred.

详细描述

As above

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female and aged between 18 and 60 years in good general health apart from suffering from headaches (test group).
  • Migraine and cluster headache will be diagnosed according to ICHD-II diagnostic criteria (6).
  • Migraineurs must suffer at least two migraine attacks per year and no more than 5 attacks per month.

排除标准

  • Any other neurological disorder such as stroke, multiple sclerosis, epilepsy, concussion within the past year, psychiatric disorders, visual disorders.
  • Use of migraine prophylactic medication in the last month or acute migraine therapy in the 3 days prior to testing.
  • Patients on any medication to treat depression in their case
  • Headache during testing or within 3 days before and after testing.

结局指标

主要结局

To see if Saccadometry results differ between controls and migraine subjects

时间窗: By May 2019

次要结局

未报告次要终点

研究者

发起方
Tim Young
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tim Young

Doctor

University College London Hospitals

研究点 (2)

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