Protective HA Factors

NCT ID: NCT02748174

Last Updated: 2018-12-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-04-30

Brief Summary

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.

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.

Conditions

Post Concussive Headache

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Episodic Migraine group

100 patients with chronic or episodic migraine

Group Type: EXPERIMENTAL

Audio Files

Intervention Type: BEHAVIORAL

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.

Chronic Migraine Group

100 patients with chronic or episodic migraine

Group Type: EXPERIMENTAL

Audio Files

Intervention Type: BEHAVIORAL

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.

Post concussive Headache Group

75 patients

Group Type: EXPERIMENTAL

Audio Files

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mia Minen, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University Langone Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

15-01055

Identifier Type: -

Identifier Source: org_study_id