Vestibular Precision: Physiology & Pathophysiology

NCT04890132 | Unknown

• 1 other identifier: 2019A015798
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This project will investigate the role of noise in the vestibular system, and in particular its effects on the variability (precision) of vestibular-mediated behaviors. The investigators will study vestibular precision in normal subjects and patients with peripheral vestibular damage, and will investigate its potential plasticity. The goals are to develop a better understanding of the role noise plays in the vestibular system in normal and pathologic populations, and to determine if the brain can learn to improve signal recognition within its inherently noisy neural environment, which would result in improved behavioral precision.

Conditions

Vestibular Schwannoma; Inner Ear Disease; Dizziness; Neurofibromatosis 2; Vestibular Disorder

Keywords

VOR variability; Vestibular Precision; Neural Noise; Motion Perception; Perceptual Precision; Vestibular Ocular Reflex

Outcome Measures

Primary Outcomes (3)

• Change in perceptual thresholds

  Measurements of motion perception thresholds (yaw for rotational tasks, roll tilt for tilt task) before and after training.

  baseline and post-training (1 hour)

• Change in rapid measure of gait

  This measure is scored before and after VOR precision training in UVD (unilateral vestibular dysfunction) patients. Gait is scored by performance on a task derived from the FGA (walking 40 feet while turning the head from side to side). It is scored on a 0 to 10 visual scale and provides a rapid assessment of vestibular function pre and post adaptation.

  baseline and post-training (1 hour)

• Change in measure of inducible dizziness

  Looking at the change between before and after VOR precision training in UVD (unilateral vestibular dysfunction) patients. Inducible dizziness is the symptom severity provoked by a task derived from the FGA (walking 40 feet while turning the head from side to side). It is scored on a 0 to 10 visual scale and provides a rapid assessment of vestibular function pre and post adaptation.

  baseline and post-training (1 hour)

Study Arms (2)

Normal Controls

EXPERIMENTAL

normal control participants - no history of neurologic or inner ear disease

Behavioral: VOR precision training

Peripheral Vestibular Dysfunction

EXPERIMENTAL

Patients with unilateral vestibular damage due to monophasic illness such as vestibular neuritis or vestibular schwannoma (VS). For VS patients, the investigators will test them in three states: pre-op, sub-acute post-op (6 weeks), and chronic post-op (6 months).

Behavioral: VOR precision training

Interventions

VOR precision training BEHAVIORAL

Subjects are rotated in yaw using a pseudo-random sum of sines motion (0.5 - 2.0 Hz), view a monitor 1 m away, and are instructed to move their avatar through a maze using a joystick. The size of the maze becomes smaller in real-time when they are successful so that the patient is at the limit of their acuity. This task requires patients to optimize dynamic visual acuity to threshold-level images while rotating. We predict that VOR precision will gradually improve during training and that after training VOR precision will be better than the pre-training data. The sham task is as above but the acuity required to see the maze will set at a much larger level so baseline visual precision will be adequate to perform the task easily.

Normal Controls; Peripheral Vestibular Dysfunction

Eligibility Criteria

• Age: 8 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Normal subjects:
• normal vestibular-oculomotor exams
• normal low-frequency standard rotational testing
• normal hearing
• Vestibular Schwannoma:
• existence of unilateral vestibular schwannoma (pre \& post surgical resection)
• must have 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

You may not qualify if:

• Normal subjects
• history of otologic or neurologic disease
• 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)

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

Study Sites (1)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Neuroma, Acoustic; Labyrinth Diseases; Dizziness; Neurofibromatosis 2; Vestibular Diseases

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurofibromatoses; Neurofibroma; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Otolaryngology and Neurology; Director, Jenks Vestibular Laboratory, Massachusetts Eye and Ear Infirmary.

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 18, 2021
• Study Start: July 1, 2020
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

US (1)