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Protective HA Factors

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2016 by New York University School of Medicine
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT02748174
First received: April 19, 2016
Last updated: September 23, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention
Post Concussive Headache Behavioral: Audio Files

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Protective Headache Factors for Migraineurs and Postconcussive Headache Patients: Are Behavioral Strategies Effective? A Naturalistic Study

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Number of completers (assessment of adherence) [ Time Frame: 90 Days ]
  • Number of days with migraine and other headache [ Time Frame: 90 Days ]
  • Number of migraine headaches [ Time Frame: 90 Days ]
  • Number of significant trigger/warning sign - migraine attack associations [ Time Frame: 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.


Estimated Enrollment: 100
Study Start Date: March 2016
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Episodic Migraine group
100 patients with chronic or episodic migraine
Behavioral: 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.
Experimental: Chronic Migraine Group
100 patients with chronic or episodic migraine
Behavioral: 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.
Experimental: Post concussive Headache Group
75 patients
Behavioral: 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02748174

Contacts
Contact: Lilliana Serrano serrano2@nyumc.org

Locations
United States, New York
New York University Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Liliana Serrano       Liliana.Serrano@nyumc.org   
Principal Investigator: Mia Minen, MD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Mia Minen, MD New York University Langone Medical Center
  More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02748174     History of Changes
Other Study ID Numbers: 15-01055
Study First Received: April 19, 2016
Last Updated: September 23, 2016

Keywords provided by New York University School of Medicine:
Migraine
Curelator

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 19, 2017