Analysis of Vestibular Compensation Following Clinical Intervention for Vestibular Schwannoma

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Migraine, Vestibular Migraine, Vestibular Schwannoma, Motion Sickness, Dizziness, Vestibular Disorder

In brief

Multiple sensory cues are typically generated by discrete events, and while they do not reach the cerebrum simultaneously, the brain can bind them temporally if they are interpreted as corresponding to a single event. The temporal binding of vestibular and non-vestibular sensory cues is poorly understood and has not been studied in detail, despite the fact that the vestibular system operates in an inherently multimodal environment. In this study, the researchers are investigating the physiology and pathophysiology of vestibular temporal binding by studying normal subjects, patients with peripheral and central vestibular dysfunction, and patients with vestibular and cochlear signals provided by prosthetic implants in the inner ear.

Key facts

Study ID: NCT04196933
Run by: Massachusetts Eye and Ear Infirmary
People needed: 0
Starts: 2019-09-05
Expected to finish: 2025-12-31
Last updated by the study team: 2025-04-16

Who can join

Age: 8 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Normal subjects
normal vestibular-oculomotor exams
normal low-frequency standard rotational testing
normal hearing
Migraine
meets International Headache Society (IHS) criteria for migraine with or without aura
tested more than 2 weeks after most recent migraine headache
Vestibular Migraine
meets Barany Society criteria for vestibular migraine, which includes:
episodic vestibular symptoms that occur with headaches that meet the IHS criteria for migraine
tested more than 2 weeks after most recent migraine headache or vestibular episode
Vestibular Schwannoma
existence of unilateral vestibular schwannoma (pre \& post clinical intervention e.g. surgical resection)
must plan to have clinical intervention such as sub-occipital surgical approach with complete sectioning of the vestibular nerve
rotational testing to assess pre-surgical vestibular function
audiogram
brain MRI consistent with vestibular schwannoma
audiography in each ear
Vestibular (VI) and Cochlear (CI) Implant subjects
scheduled for CI surgery because of deafness
minimum 5 year history of documented absence of auditory and vestibular function, based on review of their audiograms and vestibular tests
specific vestibular criteria: peak ice water caloric response of less than 3deg/s for each ear; yaw VOR time constant <3s and gain <0.25; and reduced head impulse gain (<0.25) for all canal planes
specific audiographic criteria: 80dB or greater sensorineural hearing loss in both ears

You may not qualify if…

Normal subjects
history of otologic or neurologic disease
on vestibular suppressant medication (benzodiazepine, antihistamine, anticholinergic)
pregnant or recently (<6mos) pregnant
Migraine
history of vestibular symptoms (other than motion sickness)
evidence of other neurologic or otologic dysfunction
on migraine prophylactic medications
on vestibular suppressant medication (benzodiazepine, antihistamine, anticholinergic)
Vestibular Migraine (VM)
other neurologic or otologic dysfunction as defined above except for central eye movement findings that are consistent with VM and therefore not exclusionary.
on migraine prophylactic medication
on vestibular suppressant medication (benzodiazepine, antihistamine, anticholinergic)
Vestibular Schwannoma
other otologic disease (other than presbycusis) or any neurologic disease (other than migraine)
on vestibular suppressant medication (benzodiazepine, antihistamine, anticholinergic)

Where it is running

Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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