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

Testing for vestibular dysfunction often induces dizziness and nausea, to the point that testing cannot be completed. The investigators will use a "transcranial vibration system" that has shown promise in improving comfort during testing for vestibular disorders.

The investigators hypothesize that with this "transcranial vibration system", the dizziness and nausea associated with caloric testing will be significantly reduced, while the clinical measures derived from the test will not be statistically significantly altered.

Study Overview

• Status: Recruiting
• Conditions: Dizziness; Vestibular Function Tests
• Intervention / Treatment: Device: Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Toni White; Phone Number: 410.328.2473; Email: toni.white@som.umaryland.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland
      • Contact: Laura Castellon; Phone Number: 410-328-2473; Email: lcastellon@som.umaryland.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Efficacy of vibrating system on healthy volunteers	Device: Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing; 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.
Experimental: Efficacy of vibrating system on vestibular patients	Device: Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Vestibular testing outcomes	Nystagmus associated with caloric testing (the primary clinical measure derived from caloric testing) will be compared, in the "with device" and "without device" conditions.	Vestibular clinical measures will be analyzed by a clinician upon study completion, estimated to last 6 weeks.

Collaborators and Investigators

• Sponsor: Otolith Labs
• Collaborators: University of Maryland, Baltimore
• Investigators: Principal Investigator: David J Eisenman, MD, University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Estimated): July 30, 2023
• Study Completion (Estimated): September 30, 2023

Study Registration Dates

• First Submitted: July 24, 2018
• First Submitted That Met QC Criteria: August 3, 2018
• First Posted (Actual): August 7, 2018

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: VNG; Caloric testing; vestibular nystagmography; Videonystagmography
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Vertigo; Dizziness
• Other Study ID Numbers: Olith10101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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