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Not Yet Recruiting
NCT07599228
Using Virtual Reality to Teach Mindfulness to People With Migraine
Conditions: Migraine Disorders, Migraine With Aura, Migraine Without Aura, Episodic Migraine
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 160
Sponsor: Brigham and Women's Hospital
Location: Brigham and Womens Hospital Boston Massachusetts
Summary
The aim of this clinical trial is to learn if people with migraine can learn a type of biobehavioral therapy called Acceptance and Commitment Therapy (ACT) by using a virtual reality headset. Researchers are studying if this type of mindfulness therapy helps to decrease migraine-related disability. Participants will be randomized to treatment as usual or active virtual reality groups for four weeks. Everyone will keep symptom diaries, complete surveys, attend two clinic visits, and have two blood draws.
Eligibility Criteria
Inclusion Criteria:
* Adults aged 18-80
* Diagnosed with episodic migraine and experience 4-10 migraine days/month
* On a stable dose of CGRP mAb for three months prior
* Satisfy 4 week run-in of 4-10 headaches/month
* Not taking other preventive medications
* Not pregnant, breastfeeding, or planning to become pregnant within study timeframe
* Able and willing to use VR device
* No history of significant psychiatric illness
* Willing to comply with study procedures
* English-speaking
Exclusion Criteria:
* Medication overuse (\>10 days/month)
* Vertigo/vestibular dysfunction
* Active psychiatric or neurological comorbidities
* Pregnancy, breastfeeding or planning pregnancy within study timeframe
* Significant visual/hearing/mobility impairment affecting VR use
Source: ClinicalTrials.gov (NCT07599228). StuddyBuddy aggregates publicly available trial information.