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Smartphone-Based Progressive Muscle Relaxation Therapy (PMR) for Migraine

N/A
Waitlist Available
Led By Mia 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
Meets migraine criteria based on the International Classification of Headache Disorders (ICHD) criteria
Migraine Disability Assessment (MIDAS) score >5. 4+ headache days a month.OR Meets Chronic post- traumatic headache (PTH) criteria based on International Classification of Headache Disorders (ICHD) criteria, is 3-12 months post-injury, and there are 4+ headache days a month. Scoring > or = 15 on the ISI.
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upmonth 3
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing whether a smartphone app can help people with migraines and sleep problems. The app, RELAXaHEAD, uses progressive muscle relaxation to try and help with symptoms. The study will compare people who use the app to those who receive usual care.

Eligible Conditions
  • Migraine
  • Headache
  • Multiple Sclerosis
  • Insomnia

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You experience severe headaches that meet the standards set by the International Classification of Headache Disorders (ICHD).
Select...
You have either frequent migraines with more than 4 headache days a month and a high MIDAS score, or you have chronic headaches after a head injury, with more than 4 headache days a month and a high ISI score.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 3 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 in Insomnia Severity Index Scores (ISI)
Change in Migraine Disability Assessment Scale (MIDAS) Scores
Change in Migraine-Specific Quality of Life Questionnaire-Version 2.1 (MSQv2.1) Scores
Secondary outcome measures
Change in Headache (HA) Intensity Over Past 30 Days
Change in Number of Headache (HA) Days Over Past 30 Days
Daily Diary Satisfaction Scores
+10 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: RELAXExperimental Treatment1 Intervention
Patients will receive Progressive Muscle Relaxation Therapy (PMR) via the RELAXaHEAD smart-phone app. Patients will be asked to do the following: Week 1: 5 min deep breathing at least 5/7 days of the week Week 2: 5 min PMR session at least 5/7 days of the week Week 3: 15 min PMR session at least 5/7 days of the week Week 4: PMR at least 4 days a week Week 5: PMR at least 3 days a week Weeks 6-8: Use PMR when it is most helpful Patients will be asked to track headache frequency, intensity, sleep, and acute medication use on the app. They will also receive written educational material about migraine.
Group II: Monitored Usual Care (MUC)Active Control1 Intervention
Patients will be given a general education session consisting of basic migraine information. They will receive the RELAXaHEAD app but the Progressive Muscle Relaxation Therapy (PMR) function will be blocked. Patients will be asked to track headache frequency, intensity, sleep, and acute medication use on the RELAXaHEAD app. They will also receive written educational material about migraine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Smartphone-Based Progressive Muscle Relaxation Therapy (PMR)
2022
N/A
~50

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,335 Previous Clinical Trials
795,068 Total Patients Enrolled
9 Trials studying Migraine
1,075 Patients Enrolled for Migraine
Center for Advancing Point of Care TechnologiesUNKNOWN
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,757 Previous Clinical Trials
47,221,414 Total Patients Enrolled

Frequently Asked Questions

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

Are new participants allowed to register for this study?

"As per the information posted on clinicaltrials.gov, this medical research activity is actively recruiting patients for participation. It was initially announced to the public on June 9th 2022 and underwent its last revision a month later (July 18th)."

Answered by AI

How many participants are enrolled in this experiment?

"Affirmative, the clinical trial is still recruiting participants. First posted on June 9th 2022 and most recently updated on July 18th 2022, this experiment requires 56 subjects from a single site to be enrolled."

Answered by AI

May I join the research endeavor?

"This clinical trial is enrolling 56 people, aged 18 to 80, with established migraine. Patients must also adhere to the following qualifications: ICHD classification of migraines & MIDAS scores >5 for 4+ headache days per month OR PTH diagnosis in accordance with ICHD criteria within 3-12 months post injury and ISI score ≥15."

Answered by AI

Are people aged 55 and over eligible to partake in this experiment?

"As per the study's selection criteria, participants must be between the ages of 18 and 80."

Answered by AI

What are the intended outcomes of this specific experiment?

"The primary end-point tracked over a Baseline and Month 3 period is Change in Migraine Disability Assessment Scale (MIDAS) Scores. Secondary outcomes being assessed include Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress: Depressionn Migraine Disability Assessment Scale (MIDAS) Scores. Secondary outcomes being assessed include Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress: Depression Score, Minutes/Day of Progressive Muscle Relaxation Therapy (PMR) Use among RELAX Arm Participants, and Perceived Stress Scale (PSS) Scores."

Answered by AI

Who else is applying?

What state do they live in?
Iowa
New Jersey
New York
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
NYU Langone Health
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

I have been taking ampyra.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
RELAXaHEAD for Headache Patients (Phase II)
2022. "RELAXaHEAD for Headache Patients (Phase II)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05466682.
~20 spots leftby Nov 2024
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