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

NCT06540235 | Active Not Recruiting FDA Device

• 1 other identifier: OLith10904
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Vestibular Migraine

Keywords

Vestibular Migraine; Central velocity storage; Vestibular condition; Migraine Associated Vertigo

Outcome Measures

Primary Outcomes (1)

• Reduction of time constant

  Time constant of slow-phase saccade attenuation in rotary chair

  60 minutes

Secondary Outcomes (3)

• Motion sickness symptom

  60 minutes

• Vestibular migraine handicap

  60 minutes

• Motion sickness experience

  60 minutes

Study Arms (3)

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

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

Device: Otolith Device Active

Off off off

PLACEBO COMPARATOR

Device will always be turned on but stimulation off to measure test-retest variability.

Device: Otolith Device Inactive

Interventions

Otolith Device Active DEVICE

The device will be providing different levels of stimulation hypothesized to affect the vestibular system

Off high low; Off low high

Otolith Device Inactive DEVICE

The device will be providing no stimulation to measure test-retest

Off off off

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Definite or probable vestibular migraine
• Residing in the United States

You may not qualify if:

• 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

Sponsors & Collaborators

• Otolith Labs: lead
• Dizzy and Vertigo Institute of Los Angeles: collaborator
• Medical University of South Carolina: collaborator

Study Sites (2)

Dizzy and Vertigo Institute of Los Angeles

Beverly Hills, California, 90211, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Study Officials

• Didier Depireux, PhD

  Otolith Labs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The device setting order is randomized to the participant.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 6, 2024
• Study Start: August 27, 2024
• Primary Completion: August 27, 2025
• Study Completion: November 1, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)