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

Purpose

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.

Conditions

  • Vestibular Function Tests
  • Dizziness

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
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.
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)
Masking Description
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.

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of Maryland
Baltimore, Maryland 21201
Contact:
Laura Castellon
410-328-2473
lcastellon@som.umaryland.edu

More Details

NCT ID
NCT03618199
Status
Recruiting
Sponsor
Otolith Labs

Study Contact

Laura Castellon
410.328.2473
lcastellon@som.umaryland.edu