Long-term outcomes after vestibular implantation
Long Term Outcomes After Vestibular Implantation
This study is testing how well a balance implant works for adults with chronic balance problems to see if it improves their stability and quality of life over the long term.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 22 Years to 90 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06500975 on ClinicalTrials.gov |
What this trial studies
This study evaluates the long-term effects of a vestibular implant designed to restore balance and reduce symptoms of chronic imbalance in individuals with bilateral vestibular hypofunction. It involves a single-arm open-label approach, focusing on adults who have previously received a vestibular implant and have been monitored for at least six months. The study aims to assess safety and effectiveness through various measures, including postural stability and patient-reported quality of life. A total of 15 participants will be included, with a focus on both ototoxic and non-ototoxic cases.
Who should consider this trial
Good fit: Ideal candidates are adults over 22 years old who have previously been implanted with a vestibular implant and enrolled in specific Johns Hopkins University protocols.
Not a fit: Patients who have not undergone vestibular implantation or are younger than 22 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients suffering from chronic imbalance and improve their quality of life.
How similar studies have performed: Previous studies have shown promising results with vestibular implants in ototoxic cases, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Adults older than 22 years old who * have previously been enrolled in Johns Hopkins University Institutional Review Board protocol NA\_00051349, IRB00335294 or IRB00346924 and * have previously been implanted with a vestibular implant under FDA IDE G150198
Where this trial is running
Baltimore, Maryland
- Johns Hopkins School of Medicine — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: John P Carey, MD — Johns Hopkins School of Medicine
- Study coordinator: Kelly Lane
- Email: vestibularimplant@jhmi.edu
- Phone: 410-502-8047
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.