Using a device to improve balance in patients with vestibular migraines
VIBRANT-VM: Vestibular Investigation of Bone-conducted Resonant Analysis of Time-constants in Patients With Vestibular Migraines
NA · Otolith Labs · NCT06540235
This study is testing whether a special device can help people with vestibular migraines improve their balance and reduce motion sickness and migraine symptoms.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | Otolith Labs (industry) |
| Locations | 2 sites (Beverly Hills, California and 1 other locations) |
| Trial ID | NCT06540235 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of the Otolith Labs bone conduction device on vestibular function in patients with vestibular migraines. Participants will wear the device while undergoing rotary chair testing to assess both objective and subjective measures of their vestibular system. The study aims to determine if the device can improve vestibular function compared to when it is turned off, and whether these improvements correlate with participants' experiences of motion sickness and migraine symptoms. The testing will include various settings of the device to ensure reliable results.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with definite or probable vestibular migraines who reside in the United States.
Not a fit: Patients with recent head injuries, neurodegenerative disorders, or certain ear diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of vestibular migraines and enhanced quality of life for patients.
How similar studies have performed: Other studies have shown promising results with similar approaches in vestibular rehabilitation, but the specific use of this device is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Definite or probable vestibular migraine * Residing in the United States Exclusion Criteria: * Head injury (e.g. skull fracture, concussion) within the last six months * Neurodegenerative disorder * Recent use of specified medications * History of: * Vestibular neuritis / labyrinthitis * Vestibular schwannoma or acoustic neuroma * Radiographically unexplored unilateral or sudden sensorineural hearing loss * History of surgery to the skull base or head, * Surgery to the middle ear in the past 6 months, * Surgery to the inner ear (e.g. labyrinthectomy) at any time. * Eye surgery within the previous 3 months * Significant reported history of ear disease, intravenous ototoxic medications
Where this trial is running
Beverly Hills, California and 1 other locations
- Dizzy and Vertigo Institute of Los Angeles — Beverly Hills, California, United States (RECRUITING)
- Medical University of South Carolina — Charleston, South Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Didier Depireux, PhD — Otolith Labs
- Study coordinator: Kevin Grant, MS
- Email: kevin@otolithlabs.com
- Phone: 4848415100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Vestibular Migraine, Central velocity storage, Vestibular condition, Migraine Associated Vertigo