Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT04196933
Eligibility Criteria:
Inclusion Criteria:
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
Exclusion Criteria:
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)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
80 Years
Study:
NCT04196933
Study Brief:
Protocol Section:
NCT04196933