The Effect of Bone-Conducted Stimulation on Rotary Chair Time Constants in Patients With Vestibular Migraines (VIBRANT-VM)

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:

• 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.

Study Overview

• Status: Completed
• Conditions: Vestibular Migraine
• Intervention / Treatment: Device: Otolith Device Active; Device: Otolith Device Inactive

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90211
      • Dizzy and Vertigo Institute of Los Angeles
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Off low high; Device order will start with the device turned on but stimulation off, then the low setting and then the high setting	Device: Otolith Device Active; The device will be providing different levels of stimulation hypothesized to affect the vestibular system
Experimental: Off high low; Device order will start with the device turned on but stimulation off, then the high setting and then the low setting	Device: Otolith Device Active; The device will be providing different levels of stimulation hypothesized to affect the vestibular system
Placebo Comparator: Off off off; Device will always be turned on but stimulation off to measure test-retest variability.	Device: Otolith Device Inactive; The device will be providing no stimulation to measure test-retest

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of time constant	Time constant of slow-phase saccade attenuation in rotary chair	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motion sickness symptom	Fast Motion Scale (FMS: min 0 to max 20, where "0" indicates no sickness at all and "20" indicates frank sickness)	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)	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)	60 minutes

Collaborators and Investigators

• Sponsor: Otolith Labs
• Collaborators: Medical University of South Carolina; Dizzy and Vertigo Institute of Los Angeles
• Investigators: Principal Investigator: Didier Depireux, PhD, Otolith Labs

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2024
• Primary Completion (Actual): August 15, 2025
• Study Completion (Actual): December 19, 2025

Study Registration Dates

• First Submitted: July 31, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Actual): August 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Migraine Associated Vertigo; Vestibular Migraine; Central velocity storage; Vestibular condition
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: OLith10904

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No