Protective HA Factors
Protective Headache Factors for Migraineurs and Postconcussive Headache Patients: Are Behavioral Strategies Effective? A Naturalistic Study
연구 개요
상세 설명
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.
연구 유형
단계
- 해당 없음
연락처 및 위치
연구 장소
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New York
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New York, New York, 미국, 10016
- New York University Langone Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Episodic Migraine group
100 patients with chronic or episodic migraine
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Patients will be given a link to download audio files.
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 per week.
Patients will record their headache frequency and intensivy, in addition to other symptoms, and the frequency of practiving the behavioral therapy using Curelator Headache.
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실험적: Chronic Migraine Group
100 patients with chronic or episodic migraine
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Patients will be given a link to download audio files.
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 per week.
Patients will record their headache frequency and intensivy, in addition to other symptoms, and the frequency of practiving the behavioral therapy using Curelator Headache.
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실험적: Post concussive Headache Group
75 patients
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Patients will be given a link to download audio files.
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 per week.
Patients will record their headache frequency and intensivy, in addition to other symptoms, and the frequency of practiving the behavioral therapy using Curelator Headache.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of completers (assessment of adherence)
기간: 90 Days
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90 Days
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Number of days with migraine and other headache
기간: 90 Days
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90 Days
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Number of migraine headaches
기간: 90 Days
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90 Days
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Number of significant trigger/warning sign - migraine attack associations
기간: 90 Days
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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.
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90 Days
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공동 작업자 및 조사자
수사관
- 수석 연구원: Mia Minen, MD, NYU Langone Health
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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Audio Files에 대한 임상 시험
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Brooke Army Medical CenterUniversity of Colorado, Denver모집하지 않고 적극적으로
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Damascus University완전한