Protective HA Factors
Protective Headache Factors for Migraineurs and Postconcussive Headache Patients: Are Behavioral Strategies Effective? A Naturalistic Study
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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New York
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New York, New York, Stany Zjednoczone, 10016
- New York University Langone Medical Center
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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:
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nielosowe
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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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|
Eksperymentalny: 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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|
Eksperymentalny: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Number of completers (assessment of adherence)
Ramy czasowe: 90 Days
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90 Days
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Number of days with migraine and other headache
Ramy czasowe: 90 Days
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90 Days
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Number of migraine headaches
Ramy czasowe: 90 Days
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90 Days
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Number of significant trigger/warning sign - migraine attack associations
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Mia Minen, MD, NYU Langone Health
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 15-01055
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