Virtual wellness program for migraine management

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates two non-drug virtual treatment options aimed at improving the lives of patients with migraine. Participants will engage in 8 weekly online sessions and utilize an online platform for additional resources and learning. The study allows participants to continue their current medications while they complete assessments and surveys virtually. The goal is to gather information that may enhance future migraine treatment strategies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of migraine with or without aura by with headache frequency of 4-20 days/month
* At least 1 year of migraine
* At least 18 years old
* Able to participate in 8 weekly online classes
* Willingness to complete baseline headache logs
* Headache-related disability (Headache Impact Test (HIT)-6) score \>50
* Fluent in English
* Completion of technology onboarding with the online platform
* Pregnant women who are less than or equal to 16 weeks gestation at enrollment are allowed to participate

Exclusion Criteria:

* Major unstable medical/psychiatric condition that could be unsafe for participants or for the group environment.
* Medication overuse headache, with migraine treatment
* Pregnant women who are more than 16 weeks gestation at enrollment
* Unstable migraine treatment at enrollment: any preventive treatment (oral or injectable medication or neuromodulatory device) started within 12 weeks OR acute treatment within 4 weeks to ensure stability
* Unwillingness to maintain stable current medication dosages for study duration
* Failure to complete baseline headache logs
* Heavy alcohol and illicit drug use
* Participation in another intervention clinical trial or one that would interfere in this study
* Experience with stress reduction training (daily meditation practice, regular use of a mindfulness app, or prior experience with MBSR)
* Any, and all other diagnoses or conditions which, in the opinion of the site investigator, would prevent the patient from being a suitable candidate for the study or interfere with the medical care needs of the study participant: COVID-positive test within 30 days of enrollment

Where it's running

• Wake Forest University Health Sciences
  Winston-Salem, North Carolina, United States Recruiting
• Cambridge Health Alliance - Center for Mindfulness and Compassion
  Cambridge, Massachusetts, United States Not yet recruiting
• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Not yet recruiting

Study contacts

• Principal investigator: Rebecca E Wells, MD, MPH — Wake Forest University Health Sciences
• Study coordinator: Nicole Tamol
• Email: Help4Migraine@wfusm.edu
• Phone: 336-978-1362

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Remote electrical neuromodulation to test pain inhibition in migraine and fibromyalgia

  We’re testing if the Nerivio wearable can boost the body’s natural pain-inhibition system (CPM) and reduce pain more than a sham device in adults with migraine or fibromyalgia.

  Recruiting Theranica · Bridgewater, New Jersey and 1 other locations · NCT07841509

• Elismetrep (K-304) for acute treatment of migraine

  This study tests whether a single dose of elismetrep can quickly lessen the pain of a migraine compared with placebo in adults 18 to 75.

  Recruiting at 36 sites Phase 3 TriGemX Bio, Inc. · Glendale, Arizona and 71 other locations · NCT07816367

• Magnesium sulfate for acute non-traumatic headache in the ED: 2 g vs 4 g vs standard paracetamol

  This study tests whether intravenous magnesium sulfate given in different doses helps adults with acute non-traumatic headache in the emergency department, compared with paracetamol.

  Recruiting University of Monastir · Monastir · NCT07779486

• HEADS Registry: Headache, Ear, Auditory, Dizziness, and Sinus</n> Registry

  This registry tests whether collecting online symptom reports from adults in the U.S. with sinus, vestibular, ear, or headache symptoms can help improve diagnosis and treatment.

  Recruiting Association of Migraine Disorders · North Kingstown, Rhode Island · NCT07754266

• OCT in Neurological Practice: Use of Retinal Layers to Help Diagnose and Follow Neurological Diseases

  This study tests whether optical coherence tomography (OCT) of the retina can help in diagnosing and tracking multiple sclerosis, Alzheimer's, Parkinson's, migraines, and other headaches compared with healthy people.

  Recruiting IRCCS San Raffaele · Milan, Milano · NCT07720765

• Online Hatha Yoga Add-On for High-Frequency Episodic Migraine

  This trial tests whether a 12-week online Hatha yoga program added to usual migraine treatment can help adults with high-frequency episodic migraine.

  Recruiting University of Seville · Seville, Sevilla · NCT07694063

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.