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NCT02725463 · ClinicalTrials.gov registry record · NA
Multichannel Vestibular Implant Early Feasibility Study
A NA study of Vestibular Diseases and Sensation Disorders, sponsored by Johns Hopkins University.
- Active
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT02725463: Active NA study of Vestibular Diseases and Sensation Disorders, sponsored by Johns Hopkins University.
NCT02725463 is a NA study of Vestibular Diseases and Sensation Disorders that is active but no longer recruiting, run by Johns Hopkins University. The registered enrollment target is 30 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.
The verdict
NCT02725463, a NA study of Vestibular Diseases and Sensation Disorders, is active but no longer recruiting, sponsored by Johns Hopkins University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 30 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 adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady vision due to loss of vestibular hair cell function. Preclinical studies have demonstrated that electrical stimulation of the vestibular nerve via a chronically implanted multichannel vestibular prosthesis can partially restore vestibular reflexes that maintain steady posture and vision. This pilot clinical feasibility study of a multichannel vestibular implant system will evaluate this approach in up to ten human subjects with bilateral vestibular deficiency due to gentamicin ototoxicity or other causes of inner ear dysfunction.
Primary Outcome
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events v4.3 (CTCAE v4.3)
Conditions Studied
Interventions
- DEVICE Labyrinth Devices MVI™ Multichannel Vestibular Implant
Study Locations (1)
Maryland
- Johns Hopkins School of Medicine - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2016-04 |
| Est. Completion | 2028-03-31 |
| Phase | NA |
What the registry record for NCT02725463 still lists
NCT02725463 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 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 6 conditions, with Vestibular Diseases appearing as the primary indexed condition, and to 1 intervention - of which Labyrinth Devices MVI™ Multichannel Vestibular Implant is the first listed.
NCT02725463 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02725463 about?
NCT02725463 is a clinical study titled "Multichannel Vestibular Implant Early Feasibility Study". Although cochlear implants can restore hearing to individuals who have lost cochlear hair cell function, there is no adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady vision due to loss of vestibular hair cell function. Preclinical studies ...
What is the current status of trial NCT02725463?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2016-04. Estimated completion is 2028-03-31.
What conditions does trial NCT02725463 study?
This clinical trial studies the following conditions: Vestibular Diseases, Sensation Disorders, Gentamicin Ototoxicity, Labyrinth Diseases, Other Disorders of Vestibular Function, Bilateral.
What interventions are being tested in trial NCT02725463?
The interventions under investigation include: Labyrinth Devices MVI™ Multichannel Vestibular Implant (DEVICE).
Who is sponsoring clinical trial NCT02725463?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02725463 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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