Spatial Orientation, Navigation, and Neuropsychologic Function in Patients With Vestibular Implant

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMassachusetts Eye and Ear Infirmary

About this trial

The vestibular system, located in the inner ear, provides information to the brain information about how head acceleration and orientation relative to gravity. Damage to the vestibular system is usually permanent and can contribute to a lower quality of life. The goal of this research is to to examine how vestibular implants (VI) may improve performance of cognitive tasks in patients with severe vestibular damage. These higher-level cognitive behaviors include (1) orientation relative to gravity, (2) navigation, and (3) neuropsychologic function. VI patients will be tested in these three cognitive domains across study sessions: pre-stimulation (VI implanted but stimulation OFF), following chronic stimulation (12 days, VI-ON), and then again 1 month later with the VI turned off. There will be both "true" stimulation experiments during which the VI will provide motion-modulated stimulation and also "placebo" stimulation (no motion cues, tonic stimulus). The order of these experiments will be randomized and separated by 3 months. Researchers will compare VI data in the three cognitive domains (spatial orientation, navigation, \& neuropsychologic function) with control data from non-implanted bilateral vestibular loss (BVL) and unilateral vestibular loss (UVL) patients and normal subjects.

Eligibility criteria

Qualifiers

Deaf, scheduled for CI surgery

Minimum of five year history of documented absence of bilateral auditory and vestibular function, based on review of their audiograms and vestibular tests.

Vestibular testing consistent with BVL

No neurologic disease. note: these patients are recruited and implanted by the group at the University of Geneva Hospital (UNIGE) as part of their ongoing research. The study team are not involved in any way with the decision to surgically implant patients with cochlear or vestibular implants, nor are the researchers involved in any way with pre- or post-operative clinical care. The researchers only involvement is to perform the cognitive tests before, during, and after relatively short periods of stimulation using the vestibular implant (VI)

Disqualifiers

No known neurologic or otologic disease other than the vestibular and auditory deficits noted above.

Pregnancy. Pregnant women and women up to 4 months postpartum will be excluded because of the known effects and unknown potential effects of pregnancy on sensory function.

Body weight >250 lbs (due to motion device safety limits)

The chronic use of vestibular suppressant medication (benzodiazepine, antihistamine, anticholinergic)

Trial design

Treatments tested in this trial

  • vestibular implant stimulation

Treatment groups

20 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Massachusetts Eye and Ear Infirmary

Lead sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

University of Geneva, Switzerland

Collaborator

Maastricht University

Collaborator