← Back to Search

Behavioral Intervention

RELAXaHEAD App for Migraine

N/A

Recruiting

Led By Mia T Minen, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥16 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 6

Awards & highlights

Study Summary

This trial tests a new app that may help people with migraine. It uses remote control and can be done from home.

Who is the study for?

This trial is for English-speaking individuals aged 16 or older who have been experiencing migraines for at least a year and have had a stable pattern of headaches ranging from 4-29 days per month. They must not plan to change their preventive medication during the study and should have a reduced quality of life due to migraines. People with recent relaxation therapy, substance abuse issues, severe depression, medication overuse headache, or those without access to a smartphone cannot participate.Check my eligibility

What is being tested?

The RELAXaHEAD trial is testing two versions of a smartphone app designed to help people manage their migraine symptoms. Participants will be randomly assigned one version of the app and will use it as part of their treatment routine in this remote-controlled study.See study design

What are the potential side effects?

Since this trial involves using an app rather than medication, traditional side effects are not expected. However, participants may experience frustration or lack satisfaction if they find the technology difficult to use or ineffective.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 16 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline in Modified Monthly Migraine Disability Assessment Scale (mMIDAS) Score

Secondary outcome measures

Change in Migraine Specific Quality of Life (MSQ) Version 2 Scores

Change in Monthly Headache Days (MHDs)

Trial Design

2Treatment groups

Active Control

Group I: RELAX Group 1Active Control1 Intervention

Participants will receive access to the RELAXaHEAD app version 1 which contains certain features for migraine self-management with written materials.

Group II: RELAX Group 2Active Control1 Intervention

Participants will receive access to the RELAXaHEAD app version 2 which contains certain features for migraine self-management with written and audio materials.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,494 Total Patients Enrolled

2 Trials studying Migraine

173 Patients Enrolled for Migraine

NYU Langone HealthLead Sponsor

1,369 Previous Clinical Trials

840,242 Total Patients Enrolled

9 Trials studying Migraine

767 Patients Enrolled for Migraine

Mia T Minen, MDPrincipal InvestigatorNYU Langone Health

1 Previous Clinical Trials

50 Total Patients Enrolled

1 Trials studying Migraine

50 Patients Enrolled for Migraine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the criteria for this medical trial?

"This research seeks to enroll 356 participants with migraine between the ages of 16 and 80. To qualify, applicants must meet these criteria."

Answered by AI

Are there any available slots for participants in this trial?

"Unfortunately, the study is not presently accepting candidates. Initially posted on October 1st 2023 and last edited five days later, this clinical trial has closed recruitment for now; however, there are still 178 other studies seeking participants at this time."

Answered by AI

Does this research endeavor involve individuals aged 30 and above?

"According to the specifications, adults aged 16-80 are eligible for this medical experiment. Additionally, 38 trials have been established specifically targeting minors and 125 studies focus on seniors over 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

RELAXaHEAD for Headache Patients (Phase III)

2023. "RELAXaHEAD for Headache Patients (Phase III)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06077838.

All > Migraine Headaches