Vestibular research trials

Clinical Trials. Vestibular disorders. Displaying 8 studies. Advertising Mayo Clinic is a nonprofit organization and proceeds from Web advertising help support our mission.

Advertising and sponsorship policy Advertising and sponsorship opportunities. Reprint Permissions A single copy of these materials may be reprinted for noncommercial personal use only. Vestibular Implants Tested in Human Subjects The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.

Federal Government. Read our disclaimer for details. Last Update Posted : September 27, Study Description. The goal of this study is to improve the vestibular implant's ability to reduce the vestibular-dependent perceptual, postural, and visual symptoms that affect patients with severe peripheral vestibular damage.

The long-term research plan is focused on exploring the three questions which must be answered to assess the clinical utility of a vestibular implant VI in vestibulopathic patients - i how can information transfer from the VI sensors to the brain be optimized; ii how does the three-dimensional angular velocity information provided by the VI interact in the brain with other sensorimotor vision, otolith, efferent signals; and iii how effectively does the VI alleviate the behavioral deficits and subjective symptoms experienced by patients with severe vestibular damage.

The current study will be used to focus on two key subsets of these questions. Over one year, the investigators will study approximately 5 patients who have severe bilateral vestibular damage and functioning VI's, which will focus on aim 1: how the angular velocity information sensed by the VI can be optimally transferred to the brain; and aim 2: how effectively the VI improves the clinical status of vestibulopathic patients when they receive acute and sub-acute 3 days motion-modulated stimulation.

In sum, the investigators aim to improve the efficacy of the VI in human subjects by developing new knowledge about how the brain processes motion cues provided by the VI and correlating this information with behavioral outcomes.

Detailed Description:. FDA Resources. Arms and Interventions. Specific audiographic criteria: 80dB or greater sensorineural hearing loss in both ears.

The intervention is a vestibular prosthesis which our collaborators at the University of Geneva are implanting into the inner ear in deaf patients without vestibular function who are receiving a cochlear implant. VI subjects will be studied before the implant is activated pre and then after it is turned on acute On ; this will take about 2 hrs.

Outcome Measures. Primary Outcome Measures : Changes in Postural Sway Thresholds [ Time Frame: 3 days ] Changes in threshold for postural sway, measured using IMUs inertial measurement unit placed on the upper back, head, and torso, will be assessed before prosthetic stimulation, immediately after the prosthesis is activated, and daily for 3 days following motion-modulated stimulation.

Changes in amplitude in postural sway, measured using IMUs inertial measurement unit placed on the upper back, head, and torso, will be assessed before prosthetic stimulation, immediately after the prosthesis is activated, and daily for 3 days following motion-modulated stimulation. Changes in gait dynamics, measured using IMUs inertial measurement unit placed on the upper back, head, each ankle, and torso during various physical therapy walking tasks Functional Gait Analysis , will be assessed before prosthetic stimulation, immediately after the prosthesis is activated, and daily for 3 days following motion-modulated stimulation.

This reflex which moves the eyes in response to head movement and is driven by the sensors in the inner ear. Perception of head motion and orientation relative to gravity is measured by a continuous subjective-visual-vertical SVV task where the subject uses a small steering wheel to keep a light bar orientated parallel to the perceived earth-vertical.

Participants will perform a path integration or 'complete the triangle' virtual reality task - angular error of responses is measured before prosthetic stimulation, immediately after the prosthesis is activated, and daily for 3 days following 8hrs of motion-modulated stimulation.

Participants will fill out the dizziness handicap index questionnaire before prosthetic stimulation, immediately after the prosthesis is activated, and daily for 3 days following 8hrs of motion-modulated stimulation. Participants will fill out the activities-specific balance confidence questionnaire before prosthetic stimulation, immediately after the prosthesis is activated, and daily for 3 days following 8hrs of motion-modulated stimulation.

Participants will fill out the oscillopsia functional impact scale before prosthetic stimulation, immediately after the prosthesis is activated, and daily for 3 days following 8hrs of motion-modulated stimulation.

Quality of life will be assessed by participants filling out the short form health survey scored 0 to points before prosthetic stimulation, immediately after the prosthesis is activated, and daily for 3 days following 8hrs of motion-modulated stimulation. Cognitive impairment will be assessed by participants completing a neuropsychological test battery with a focus on visual-spatial tasks before prosthetic stimulation, immediately after the prosthesis is activated, and daily for 3 days following 8hrs of motion-modulated stimulation.

Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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