Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Protective HA Factors

4. december 2018 opdateret af: NYU Langone Health

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

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.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New York
      • New York, New York, Forenede Stater, 10016
        • New York University Langone Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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:

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Episodic Migraine group
100 patients with chronic or episodic migraine
Adfærdsmæssigt: Audio Files
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.
Eksperimentel: Chronic Migraine Group
100 patients with chronic or episodic migraine
Adfærdsmæssigt: Audio Files
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.
Eksperimentel: Post concussive Headache Group
75 patients
Adfærdsmæssigt: Audio Files
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of completers (assessment of adherence)
Tidsramme: 90 Days
90 Days
Number of days with migraine and other headache
Tidsramme: 90 Days
90 Days
Number of migraine headaches
Tidsramme: 90 Days
90 Days
Number of significant trigger/warning sign - migraine attack associations
Tidsramme: 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.
90 Days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

NYU Langone Health

Efterforskere

  • Ledende efterforsker: Mia Minen, MD, NYU Langone Health

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2016

Primær færdiggørelse (Faktiske)

1. april 2018

Studieafslutning (Faktiske)

1. april 2018

Datoer for studieregistrering

Først indsendt

19. april 2016

Først indsendt, der opfyldte QC-kriterier

21. april 2016

Først opslået (Skøn)

22. april 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. december 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. december 2018

Sidst verificeret

1. december 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 15-01055

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hovedpine efter hjernerystelse

Kliniske forsøg med Audio Files

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Italy

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner