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Protective HA Factors

4 december 2018 uppdaterad av: 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.

Studieöversikt

Status

Indragen

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • New York
      • New York, New York, Förenta staterna, 10016
        • New York University Langone Medical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Episodic Migraine group
100 patients with chronic or episodic migraine
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.
Experimentell: Chronic Migraine Group
100 patients with chronic or episodic migraine
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.
Experimentell: Post concussive Headache Group
75 patients
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of completers (assessment of adherence)
Tidsram: 90 Days
90 Days
Number of days with migraine and other headache
Tidsram: 90 Days
90 Days
Number of migraine headaches
Tidsram: 90 Days
90 Days
Number of significant trigger/warning sign - migraine attack associations
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Mia Minen, MD, NYU Langone Health

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 mars 2016

Primärt slutförande (Faktisk)

1 april 2018

Avslutad studie (Faktisk)

1 april 2018

Studieregistreringsdatum

Först inskickad

19 april 2016

Först inskickad som uppfyllde QC-kriterierna

21 april 2016

Första postat (Uppskatta)

22 april 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 december 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 december 2018

Senast verifierad

1 december 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 15-01055

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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