Simultaneous Recordings of Cervical and Ocular Vestibular-evoked Myogenic Potentials

Vestibular Function Disorder Clinical Trial

Official title:

Clinical Utility of Simultaneous Recordings of Cervical and Ocular Vestibular-evoked Myogenic Potentials During Monaural Stimulation

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03049683
• Other study ID #: ChonbukNU
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 21, 2016
• Last updated: February 8, 2017
• Start date: October 2016
• Est. completion date: March 2017

Study information

• Verified date: February 2017
• Source: Chonbuk National University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To lower the threshold for clinical application by reducing the testing time for recording vestibular-evoked myogenic potentials (VEMPs), we evaluated whether a simultaneous recording of ocular and cervical VEMPs after unilateral or bilateral stimulation can be achieved without a loss in diagnostic sensitivity.

Description:

The combined evaluation of ocular and cervical VEMPs permits the assessment of both endorgans and whole vestibular nerve function, as well as the ascending and descending vestibular pathways in the brainstem at once.

In about 30 healthy participants and 20 patients with acute unilateral vestibular neuritis, unilateral simultaneous cVEMP and oVEMP recordings in each side during monaural stimulation (air-conducted sound, 500Hz tone bursts, 100 nHL), and bilateral simultaneous recordings of each VEMP while binaural stimulation were compared to the conventional method of sequential recording each VEMPs on each side at a time.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: March 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 85 Years

Eligibility

Inclusion Criteria:

1. acute onset of vertigo

2. the appearance of mixed horizontal and torsional nystagmus

3. impaired horizontal semicircular canal (SCC) function on head-impulse test and a unilaterally absent or reduced caloric response (i.e., a caloric paresis score > 25%)

4. intact inferior division of vestibular nerve as evidenced by normal cVEMP and normal head-impulse test for vertical SCCs

5. the absence of auditory and neurologic signs

Exclusion Criteria:

• a previous history of vertigo or neuro-otologic diseases

Related Conditions & MeSH terms

• Vestibular Diseases
• Vestibular Function Disorder

Intervention

Other:
• Vestibular evoked myogenic potentials (VEMPs)
The c- and oVEMPs will be assessed in three different sessions including conventional sequential recordings and two different simultaneous recording methods, i.e., unilateral simultaneous recording of cVEMPs and oVEMPs during monaural stimulation (Figure 1A) and bilateral simultaneous recording of each VEMP during binaural stimulation (Figure 1B).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical utility of simultaneous recordings of cervical and ocular vestibular-evoked myogenic potentials during monaural stimulation	The changes in the mean time for each recording	6 months
Secondary	Clinical utility of simultaneous recordings of cervical and ocular vestibular-evoked myogenic potentials during monaural stimulation	VEMP parameters: latency	6 months
Secondary	Clinical utility of simultaneous recordings of cervical and ocular vestibular-evoked myogenic potentials during monaural stimulation	VEMP parameters: peak-to-peak amplitude	6 months
Secondary	Clinical utility of simultaneous recordings of cervical and ocular vestibular-evoked myogenic potentials during monaural stimulation	VEMP parameters: threshold	6 months