NCT02748174

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

December 6, 2018

Status Verified

December 1, 2018

Enrollment Period

2.1 years

First QC Date

April 19, 2016

Last Update Submit

December 4, 2018

Conditions

Post Concussive Headache

Keywords

MigraineCurelator

Outcome Measures

Primary Outcomes (4)

  • Number of completers (assessment of adherence)

    90 Days

  • Number of days with migraine and other headache

    90 Days

  • Number of migraine headaches

    90 Days

  • Number of significant trigger/warning sign - migraine attack associations

    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

Study Arms (3)

Episodic Migraine group

EXPERIMENTAL

100 patients with chronic or episodic migraine

Behavioral: Audio Files

Chronic Migraine Group

EXPERIMENTAL

100 patients with chronic or episodic migraine

Behavioral: Audio Files

Post concussive Headache Group

EXPERIMENTAL

75 patients

Behavioral: Audio Files

Interventions

Audio FilesBEHAVIORAL

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 GroupEpisodic Migraine groupPost concussive Headache Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mia Minen, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2016

First Posted

April 22, 2016

Study Start

March 1, 2016

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

December 6, 2018

Record last verified: 2018-12

Locations

US(1)