Vestibular MigraineVIBRANT-VMNCT06540235
The Effect of Bone-Conducted Stimulation on Rotary Chair Time Constants in Patients With Vestibular Migraines
A study testing Otolith Device Active and Otolith Device Inactive in people with Vestibular Migraine, run by Otolith Labs at 2 sites in United States.
Trial summary
The goal of this clinical trial is to learn if the Otolith Labs device can improve vestibular function of subjects with vestibular migraine. The main questions it aims to answer are: When the Otolith Labs device is on, are objective measures of the vestibular system better than when the device is off? When the Otolith… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Vestibular Migraine
- What is being tested?
- Otolith Device Active and Otolith Device Inactive
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Aug 2024to 19 Dec 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Definite or probable vestibular migraine
- Residing in the United States
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dizzy and Vertigo Institute of Los Angeles
Beverly Hills, California, 90211
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: VIBRANT-VM: Vestibular Investigation of Bone-conducted Resonant Analysis of Time-constants in Patients With Vestibular Migraines
The goal of this clinical trial is to learn if the Otolith Labs device can improve vestibular function of subjects with vestibular migraine.
The main questions it aims to answer are:
Read more
- When the Otolith Labs device is on, are objective measures of the vestibular system better than when the device is off?
- When the Otolith Labs device is on are subjective measures of the vestibular system better than when the device is off?
- Are the objective measures related to the subjective measures?
Researchers will change the order of the device settings to ensure the changes aren't due to the order they are tested.
Participants will:
- Wear the Otolith Labs device while in a rotary chair at different settings for different tests. All of the rotary chair testing will take less than an hour.
- Answer questions about how the rotary chair testing made them feel for each test.
- Answer questions about their every-day susceptibility to motion sickness and about their vestibular migraine symptoms.
Read the detailed description
This study is designed to investigate the effects of The Otolith Labs bone conduction device (BCD) on the vestibular system. In the context of this trial, the BCD was designed and developed to reduce the effects of external stimulation of the vestibular system. The eventual intended use of the device is for people who have vestibular disorders (e.g. Vestibular Migraine, Meniere's Disease) who may benefit from a device that can provide a normalizing response to an abnormal vestibular neural signal.
To better understand the functioning principles of the BCD, the investigators want to conduct standard clinical testing using a rotary chair, specifically
- Step velocity testing (SVT) with the chair rotating and vision denied
- Optokinetic testing (OKT) with the chair stationary and visual field moving
Published studies have demonstrated that a reduction in the vestibulo-ocular reflex (VOR) time constants during optokinetic and velocity step testing is correlated with improved motion sickness symptoms. The investigators aim to determine if the BCD similarly reduces the VOR time constant. A reduction in time constant has been shown to be strongly correlated with a reduced time constant of integration in the central velocity storage (a long time constant very strongly correlates with motion sensitivity and with the severity of vestibular migraine episodes.
In this study, the BCD is set at one of three settings- turned off, low power level, high power level, -while the participant is undergoing testing at 60 °/s (patient's own motion for step velocity testing, or projected image for OKT). The same test methodology and equipment shall be used for all participants. In total, 6 rotational tests - one clockwise rotation and one counterclockwise rotation at each of the three power settings, and 6 static tests - with the visual field moving left then right at each of the three power settings, will be conducted and the order of the high/low power settings will be randomized to the second/third set of SVT and OKT. The device is adjusted to a new power level a few seconds before initiating each SVT and OKT.
Eye movements will be tracked during the SVT and OKT to evaluate decay in amplitudes and frequency of nystagmus over time (typically around 15 seconds). Comparison will be made between the three power conditions to evaluate the effect of bone conduction stimulation on the vestibular sense stimulated by rotation.
The participant will be prompted to report on the Fast Motion Scale (FMS) - a simple, validated 20 point verbally reported numerical rating scale - prior to and following each chair session to gauge the momentary level of motion sickness perception. The FMS will be reported a total of 12 times per participant (pre- \& post-rotary tests).
Participants will complete the Motion Sickness Sensitivity Questionnaire Short Form (MSSQ-SF) to determine their history of sensitivity to provocative motion. Participants will also complete the Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) to assess the correlation of the potential change in time constants and VOR gain to the perceived severity of their vestibular migraine condition.
- Conditions
- Vestibular Migraine
- Being tested
- Otolith Device Active, Otolith Device Inactive
- Keywords
- Vestibular Migraine, Central velocity storage, Vestibular condition, Migraine Associated Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otolith Device ActiveDevice
The device will be providing different levels of stimulation hypothesized to affect the vestibular system
Otolith Device InactiveDevice
The device will be providing no stimulation to measure test-retest
| Study group | Role | What they receive |
|---|---|---|
| Off low high | Experimental | Device order will start with the device turned on but stimulation off, then the low setting and then the high setting Receives: Device: Otolith Device Active |
| Off high low | Experimental | Device order will start with the device turned on but stimulation off, then the high setting and then the low setting Receives: Device: Otolith Device Active |
| Off off off | Placebo comparator | Device will always be turned on but stimulation off to measure test-retest variability. Receives: Device: Otolith Device Inactive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of time constant
Time constant of slow-phase saccade attenuation in rotary chair
Measured: 60 minutes
Secondary outcomes (3)
Motion sickness symptom
Fast Motion Scale (FMS: min 0 to max 20, where "0" indicates no sickness at all and "20" indicates frank sickness)
Measured: 60 minutes
Vestibular migraine handicap
Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI: min 0 to max 100, where "0" indicates no handicap at all and "100" indicates complete handicap)
Measured: 60 minutes
Motion sickness experience
Motion Sickness Susceptibility Questionnaire Short-form (MSSQ-Short: min 0 to max 54, where "0" indicates never sick and "54" indicates frequently sick)
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start27 Aug 2024
- Primary completion15 Aug 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otolith Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dizzy and Vertigo Institute of Los Angeles, Medical University of South Carolina
- Responsible party
- Sponsor
- Investigators
- Didier Depireux, PhD, Principal investigator, Otolith Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540235
- Sponsor's protocol ID
- OLith10904
- Acronym
- VIBRANT-VM
- Status last verified
- May 2026
- First submitted
- 31 Jul 2024
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.