Analysis of Vestibular Compensation Following Clinical Intervention for Vestibular Schwannoma (NCT04196933) | Clinical Trial Compass
WithdrawnNot Applicable
Analysis of Vestibular Compensation Following Clinical Intervention for Vestibular Schwannoma
Stopped: Following further collection and analysis of temporal binding data, we found the relationship between PSS and clinical outcomes to not be strong enough for adaptation.
United States0Started 2019-09-05
Plain-language summary
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.
Who can participate
Age range
8 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 sensorineu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in postural sway/balance
Timeframe: baseline and post-PSS adaptation (1 hour)
2
Change in rapid measure of gait
Timeframe: baseline and post-PSS adaptation (1 hour)
3
Change in measure of inducible dizziness
Timeframe: baseline and post-PSS adaptation (1 hour)
4
Change in Point of Subjective Simultaneity (PSS)
Timeframe: baseline and 1 hour post 8-hour VI-CI 'physiologic' stimulation