RECRUITING

Long Term Outcomes After Vestibular Implantation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Long Term Outcomes After Vestibular Implantation

Quick Facts

Study Start:2024-12-01
Study Completion:2029-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06500975

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Kelly Lane
CONTACT
410-502-8047
vestibularimplant@jhmi.edu
Charles C Della Santina, MDPhD
CONTACT
410-502-8047
cds@jhmi.edu

Principal Investigator

John P Carey, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins School of Medicine

Study Locations (Sites)

Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • John P Carey, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-01
Study Completion Date2029-12

Study Record Updates

Study Start Date2024-12-01
Study Completion Date2029-12

Terms related to this study

Keywords Provided by Researchers

  • Vestibular
  • Implant
  • Prosthesis
  • Labyrinth
  • Ototoxicity
  • Gentamicin
  • Oscillopsia
  • Disequilibrium
  • Dizziness
  • Vestibulopathy
  • Inner Ear

Additional Relevant MeSH Terms

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