Protective HA Factors
Protective Headache Factors for Migraineurs and Postconcussive Headache Patients: Are Behavioral Strategies Effective? A Naturalistic Study
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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New York
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New York, New York, Yhdysvallat, 10016
- New York University Langone Medical Center
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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:
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei satunnaistettu
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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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|
Kokeellinen: 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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Kokeellinen: 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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Number of completers (assessment of adherence)
Aikaikkuna: 90 Days
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90 Days
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Number of days with migraine and other headache
Aikaikkuna: 90 Days
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90 Days
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Number of migraine headaches
Aikaikkuna: 90 Days
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90 Days
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Number of significant trigger/warning sign - migraine attack associations
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Mia Minen, MD, NYU Langone Health
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 15-01055
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