Clinical trial NCT06540235: The Effect of Bone-Conducted Stimulation on Rotary Chair Time Constants in Patients With Vestibular Migraines
Official title: VIBRANT-VM: Vestibular Investigation of Bone-conducted Resonant Analysis of Time-constants in Patients With Vestibular Migraines
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vestibular Migraine
Keywords: Vestibular Migraine
Central velocity storage
Vestibular condition
Migraine Associated Vertigo
Lead sponsor: Otolith Labs
Sponsor class: INDUSTRY
Collaborators: name: Dizzy and Vertigo Institute of Los Angeles
name: Medical University of South Carolina
First posted: 2024-08-06
Enrollment: 42
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Reduction of time constant
timeFrame: 60 minutes
Secondary outcomes:
measure: Motion sickness symptom
timeFrame: 60 minutes
measure: Vestibular migraine handicap
timeFrame: 60 minutes
measure: Motion sickness experience
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Dizzy and Vertigo Institute of Los Angeles
state: California
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Otolith Labs
name: Didier Depireux, PhD
role: PRINCIPAL_INVESTIGATOR
References: