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临床试验/NCT02748174
NCT02748174撤回不适用

Protective Headache Factors for Migraineurs and Postconcussive Headache Patients: Are Behavioral Strategies Effective? A Naturalistic Study

NYU Langone Health2 个研究点 分布在 1 个国家开始时间: 2016年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Number of completers (assessment of adherence)

研究概览

简要总结

This is a naturalistic study of 100 migraineurs and 75 post concussive headache patients who will be asked to record their headaches, medications, sleep and other behaviors in a smartphone app called Curelator. The software was developed to identify possible headache triggers. We seek to determine whether there might be protective headache factors. Patients will be given audio files with relaxation therapies. We seek to understand whether this self relaxation therapy and/or traditional evidence based behavioral treatment recommended during a patient visit is protective against migraine attacks.

详细描述

Patients will be given a link to audio files on dropbox which they can download onto their smartphone. They consist of breathing techniques, imaging, progressive relaxation, and more. Patients will be asked to perform 20 minutes of relaxation therapy at least 3 times a week. Patients will record their headache frequency and intensity, in addition to other symptoms, and the frequency of practicing the behavioral therapy using Curelator Headache. ™ Curelator Inc. (Cambridge USA) has developed a proprietary, non-pharmaceutical, digital platform, called Curelator Headache,™ to collect daily data, identify trigger-attack associations and propose 'tests' of trigger modification.

The Curelator approach requires high quality data from the individual, entered on a daily basis. Compliance is expected to be enhanced because the study if being offered by the individual's healthcare provider.

This a pilot study of an initial 90 days use of a digital platform to identify potential migraine protective factors (Curelator Headache™) in subjects with physician-diagnosed episodic or chronic migraine or post-concussive headache. Subjects are recruited to Curelator Headache use by a physician and enter data each day. The baseline period (90 days) is followed by a test period (90 days) during which, under Curelator guidance, subjects make one or more modifications to their behaviors based on the data from the 90 day period.

The study will include up to 100 patients with chronic or episodic migraine and 75 patients with postconcussive headache. At clinics, investigators will offer participation to consecutive migraine patients with 6-20 headache days a month and to consecutive concussion patients complaining of headache more than 1 month post concussive event.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
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

入选标准

  • Male or female reporting at least 6 month history of episodic or chronic migraine with 6-20 headache days a month
  • Age: 18-65 years
  • Age of onset of migraine was <age 50
  • Able to give informed consent/assent
  • Sufficiently fluent in English to be able to use the English language version of Curelator Headache (no translations available).
  • Has ownership of or reliable access to iPhone or (mini) iPad running iOS 7 or higher
  • Able to give written informed consent (adults), or, for adolescents, has a parent/caregiver who can give informed consent and adolescent is able to give assent.
  • Willing to use Curelator Headache for at least 3 months and to comply with study procedures.
  • In the Investigator's opinion, there is no reason to believe that Curelator Headache use would pose any risk to the patient.

排除标准

  • 未提供

研究组 & 干预措施

Episodic Migraine group

Experimental

100 patients with chronic or episodic migraine

干预措施: Audio Files (Behavioral)

Chronic Migraine Group

Experimental

100 patients with chronic or episodic migraine

干预措施: Audio Files (Behavioral)

Post concussive Headache Group

Experimental

75 patients

干预措施: Audio Files (Behavioral)

结局指标

主要结局

Number of completers (assessment of adherence)

时间窗: 90 Days

Number of days with migraine and other headache

时间窗: 90 Days

Number of migraine headaches

时间窗: 90 Days

Number of significant trigger/warning sign - migraine attack associations

时间窗: 90 Days

This will be analyzed by means of univariate Cox Proportional Hazards (PH) models. At the end of the study period (Day 90) significant trigger factors (HR/RR\>1 and p-value ≤ 0.05) will be identified for each individual: the number and percentage of subjects with at least one significant relationship between a trigger and occurrence of migraine attacks and the number of trigger-migraine attack significant relationships per individual will be estimated by means of descriptive statistics.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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