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NCT06500975 · ClinicalTrials.gov registry record · NA

Long Term Outcomes After Vestibular Implantation

A NA study of Vestibular Diseases and Sensation Disorders, sponsored by Johns Hopkins University.

Recruiting
Registry status
NA
Development phase
32
Enrollment target
1
Study location

NCT06500975: Recruiting NA study of Vestibular Diseases and Sensation Disorders, sponsored by Johns Hopkins University.

NCT06500975 is a NA study of Vestibular Diseases and Sensation Disorders that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 32 participants, below the 13,366-participant average among 6 other Vestibular Diseases trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06500975, a NA study of Vestibular Diseases and Sensation Disorders, is actively recruiting participants, sponsored by Johns Hopkins University.

RECRUITING
Registry status
NA
Development phase
32 participants
Enrollment target
1
Study location

Study Summary

Although cochlear implants can restore hearing to individuals who have lost cochlear hair cell function, there is no widely available, adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady vision due to bilateral vestibular hypofunction. Prior research focused on ototoxic cases has demonstrated that electrical stimulation of the vestibular nerve via a chronically implanted multichannel vestibular implant can partially restore vestibular reflexes that normally maintain steady posture and vision; improve performance on objective measures of postural stability and gait; and improve patient-reported disability and health-related quality of life. This single-arm open-label study extends that research to evaluate outcomes for up to 8 individuals with non-ototoxic bilateral vestibular hypofunction, yielding a total of fifteen adults (age 22-90 years at time of enrollment) divided as equally as possible between ototoxic and non-ototoxic cases.

Primary Outcome

DGI comprises 8 gait tasks scored by an examiner: walking on a level surface, changing gait speed, walking during horizontal head turns, walking during vertical head turns, pivoting, stepping over an obstacle, stepping around obstacles, and waling up and down stairs. Each task is scored (0-3 points, 3 is best). Raw DGI score is the sum of the eight subtest scores and ranges from 0 to 24, with higher scores meaning better outcome and minimally important difference 3.2 points.

Conditions Studied

Vestibular Diseases Sensation Disorders Gentamicin Ototoxicity Labyrinth Diseases Bilateral Vestibular Hypofunction Bilateral Vestibulopathy Bilateral Vestibular Deficiency Aminoglycoside Toxicity Other Disorders of Vestibular Function

Interventions

  • DEVICE Labyrinth Devices MVI™ Multichannel Vestibular Implant System

Study Locations (1)

Maryland

  • Johns Hopkins School of Medicine - Baltimore

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2024-12-01
Est. Completion 2029-12
Phase NA
Johns Hopkins University

1,448 total trials

What NCT06500975 shows while recruiting

NCT06500975 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 13,366-participant average among 6 other Vestibular Diseases trials with a reported enrollment target (100% lower).

The record links to 9 conditions, with Vestibular Diseases appearing as the primary indexed condition, and to 1 intervention - of which Labyrinth Devices MVI™ Multichannel Vestibular Implant System is the first listed.

NCT06500975 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT06500975 about?

NCT06500975 is a clinical study titled "Long Term Outcomes After Vestibular Implantation". Although cochlear implants can restore hearing to individuals who have lost cochlear hair cell function, there is no widely available, adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady vision due to bilateral vestibular hypofunction. Prior ...

What is the current status of trial NCT06500975?

This trial is currently recruiting. It is a NA study. The enrollment target is 32 participants. The study started on 2024-12-01. Estimated completion is 2029-12.

What conditions does trial NCT06500975 study?

This clinical trial studies the following conditions: Vestibular Diseases, Sensation Disorders, Gentamicin Ototoxicity, Labyrinth Diseases, Bilateral Vestibular Hypofunction.

What interventions are being tested in trial NCT06500975?

The interventions under investigation include: Labyrinth Devices MVI™ Multichannel Vestibular Implant System (DEVICE).

Who is sponsoring clinical trial NCT06500975?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06500975 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT06500975

Source: ClinicalTrials.gov NCT06500975, the US trial registry maintained by the National Library of Medicine. NCT06500975 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.