- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02748174
Protective HA Factors
Protective Headache Factors for Migraineurs and Postconcussive Headache Patients: Are Behavioral Strategies Effective? A Naturalistic Study
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
New York
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New York, New York, Stati Uniti, 10016
- New York University Langone Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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:
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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.
|
Sperimentale: 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.
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Number of completers (assessment of adherence)
Lasso di tempo: 90 Days
|
90 Days
|
|
Number of days with migraine and other headache
Lasso di tempo: 90 Days
|
90 Days
|
|
Number of migraine headaches
Lasso di tempo: 90 Days
|
90 Days
|
|
Number of significant trigger/warning sign - migraine attack associations
Lasso di tempo: 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
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Mia Minen, MD, NYU Langone Health
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 15-01055
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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