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临床试验/NCT03099070
NCT03099070终止不适用

Acute Stress Response in Migraine Sufferers

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年3月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
90
试验地点
1
主要终点
Headache/Medication Use

研究概览

简要总结

This study will examine the influence of stress and fasting on headache activity. Participants will receive both a control and stress session and be randomized to either fasting or not fasting for the visits.

详细描述

Stress and headache are intricately interrelated. Stress is thought to contribute to headache disorder onset in predisposed individuals, trigger or worsen individual headache episodes in those with headache, and exacerbate the progression of a headache disorder. In exacerbating headache disorder progression, stress is believed to be a major factor in headache transformation from an episodic to a chronic condition.

Broadly stated, stress is conceptualized as an imbalance between a demand, whether actual or perceived, and resources to handle the demand, resulting in a strain on the system. A stressor is any challenge or threat, whether objectively verified or not, to normal functioning. The stress response is the body's activation of physiological systems to protect and restore functioning.

This study is 2 x 2 experiment using male and female migraine sufferers. Participants will be randomized to a fasting or not fasting condition for the visits. Thus, the experiment is a 2 (control versus stress) x 2 (fasting versus not). During the approximately 4 weeks of participation (ranging from 9 to a maximum of 28 days), a participant also will complete a twice-daily diary.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Women and men 18-65 years of age
  • •A provisional diagnosis of migraine (with or without aura).
  • •Headache frequency of 2 to 15 attacks/month

排除标准

  • •Presence of a secondary headache disorder (e.g., brain tumor)
  • •Chronic daily headache (> 15 headache days/month) or medication over-use headache (> 8 abortive medication doses/month)
  • •Recent change in nature of headache symptoms over last 6 weeks
  • •Not being able to read or speak English at a 6th grade level
  • •Any condition that would preclude the safe experience of a benign laboratory stressor including seizure disorder, Axis-I psychotic disorder, unstable cardiac conditions
  • •An active substance dependence issue (e.g., alcohol, marijuana) that interferes with data collection and headache activity.

研究组 & 干预措施

Control, Not-Fasting

No Intervention

Participants will experience the control intervention and will not fast prior to the lab visit.

Control, Fasting

Experimental

Participants will experience the control intervention and will fast prior to the lab visit.

干预措施: Fasting (Other)

Stress, Not-Fasting

Experimental

Participants will experience the stress intervention and will not fast prior to the lab visit.

干预措施: Stress (Behavioral)

Stress, Fasting

Experimental

Participants will experience the stress intervention and will fast prior to the lab visit.

干预措施: Stress (Behavioral)

Stress, Fasting

Experimental

Participants will experience the stress intervention and will fast prior to the lab visit.

干预措施: Fasting (Other)

结局指标

主要结局

Headache/Medication Use

时间窗: Duration of lab visit (6 hours)

The presence of a headache attack that is \>= 4/10 on a 0 to 10 scale or a headache attack that requires the use of abortive/analgesic medication

次要结局

  • Pain Scores(6 hours)
  • Medication use(48 hours)
  • Time to next headache attack(48 hours)

研究者

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

Timothy Houle

Associate Scientist

Massachusetts General Hospital

研究点 (1)

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