Efficacy of a Transcranial Vibrating System for Minimizing Dizziness During Caloric Testing

NCT03618199 | Completed DMC FDA Device

• 1 other identifier: Olith10101
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Vestibular disorders are among the most common causes of disability in society. Vestibular dysfunction affects over one third of the population over the age of 40 and a significant percentage of the younger population. Vestibular disorders have a dramatic impact on daily life impacting work, relationships, and even activities of daily living. Diagnosis of vestibular disorders is often facilitated by functional vestibular tests. The most common of these tests is videonystagmography, during a critical portion of which, the "caloric test," warm and cool stimuli are presented in the outer ears to stimulate the inner ear vestibular system. The vertigo produced by caloric stimulation not uncommonly results in nausea, and sometimes vomiting, sometimes to the point of not being able to complete the test protocol. In this project we examine a device that has shown promise and might be beneficial for improving the testing for vestibular disorders. We hypothesize that with this device, the nausea associated with caloric testing will be significantly reduced when the device is used, while it will not change the results of the test in a statistically significantly manner. To date, the device has only been systematically tested on healthy volunteers.

Conditions

Vestibular Function Tests; Dizziness

Keywords

Caloric testing; vestibular nystagmography; VNG; Videonystagmography

Outcome Measures

Primary Outcomes (1)

• Nausea and dizziness

  Visual Analog Scales (VAS, adapted from "Visual Vertigo Analogue Scale" for dizziness and "Baxter Retching Faces (BARF)" for nausea) will be filled out by the subject ten minutes after each phase of the caloric testing, i.e. "with" and "without" the transcranial vibration system. Each phase of the caloric testing itself takes approximately 30 minutes. These Visual Analog Scales range from 0 to 10 (None to Agonizing). They will provide independent measures of the effectiveness of the transcranial vibration system.

  VAS administered ten minutes post-caloric testing; data will be analyzed upon study completion, estimated to last 6 weeks

Secondary Outcomes (1)

• Vestibular testing outcomes

  Vestibular clinical measures will be analyzed by a clinician upon study completion, estimated to last 6 weeks.

Study Arms (2)

Efficacy of vibrating system on healthy volunteers

EXPERIMENTAL

Device: Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing

Efficacy of vibrating system on vestibular patients

EXPERIMENTAL

Device: Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing

Interventions

Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing DEVICE

Transcranial vibrating system will be on then off (or off then on in a random order) during a repeated application of the "calorics testing" stimulus, i.e. warm or cold water irrigated in the left (then right) ear canal. The effect of the vibrating system on 1) resulting dizziness and nausea often experienced by patients and 2) clinical parameters measured by caloric testing will be quantified.

Efficacy of vibrating system on healthy volunteers; Efficacy of vibrating system on vestibular patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject can speak and comprehend English.
• Subject can stand a strap placed on their head for an hour.

You may not qualify if:

• History of head injury within the last six months
• Presence of severe aphasia
• History of diagnosed neuropsychiatric disorders
• Documented neurodegenerative disorders
• Pregnancy \[Female candidates will be asked if they are pregnant\]
• History of Cerebrovascular disorders
• History of ear operation other than myringotomy and tube placement in the past

Sponsors & Collaborators

• Otolith Labs: lead
• University of Maryland, Baltimore: collaborator

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Dizziness

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David J Eisenman, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Subject in both phases will immediately know whether the transcranial vibrating system is on. Analysis of outcomes (1-dizziness, 2-nausea, 3-clinical measures from vestibular nystagmography resulting from the caloric testing) will be blinded.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: First phase: test 20 subjects. They will undergo the "caloric testing" part of the standard vestibular testing, with and without our transcranial vibration system (10 with device on then off, 10 with device off then on) and will describe their state on a "visual analog scale" (both dizziness and nausea) at the end. Success is 1) substantially reduced dizziness ad nausea, 2) statistically unchanged clinical measures. If (and only if) the first phase is successful, we proceed to the second phase. Second phase: identical to first phase, but is conducted with patients coming in the clinic for vestibular testing. The order ("device on" first, or second) will be randomly assigned.

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 7, 2018
• Study Start: October 1, 2018
• Primary Completion: August 22, 2022
• Study Completion: August 22, 2022
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)