AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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
Show all 12Show fewer
  • 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

Other trials in United States

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

  1. Step velocity testing (SVT) with the chair rotating and vision denied
  2. 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.

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 groups in NCT06540235
Study groupRoleWhat they receive
Off low highExperimentalDevice 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 lowExperimentalDevice 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 offPlacebo comparatorDevice 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.

  1. Reduction of time constant

    Time constant of slow-phase saccade attenuation in rotary chair

    Measured: 60 minutes

Secondary outcomes (3)
  1. 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

  2. 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

  3. 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.

  1. First posted6 Aug 2024
  2. Study start27 Aug 2024
  3. Primary completion15 Aug 2025
  4. Study completion19 Dec 2025

Resources

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)
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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in