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New treatment option for Vestibular Dysfunction
Official title Spatial Orientation, Navigation, and Neuropsychologic Function in Patients With Vestibular Implant
ClinicalTrials.gov ID: NCT07627087
What this study is testing
- What it's testing
- The vestibular system, located in the inner ear, provides information to the brain information about how head acceleration and orientation relative to gravity. Damage to the vestibular system is usually permanent and can contribute to a lower quality of life.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Patients receiving vestibular implants at UNIGE: Their are defined as follows:
- Deaf, scheduled for CI surgery
- Minimum of five year history of documented absence of bilateral auditory and vestibular function, based on review of their audiograms and vestibular...
- Vestibular testing consistent with BVL
- No neurologic disease. note: these patients are recruited and implanted by the group at the University of Geneva Hospital (UNIGE) as part of their...
You likely can't join if
- Exclusion Criteria:
- No known neurologic or otologic disease other than the vestibular and auditory deficits noted above.
- Pregnancy. Pregnant women and women up to 4 months postpartum will be excluded because of the known effects and unknown potential effects of...
- Body weight \>250 lbs (due to motion device safety limits)
- The chronic use of vestibular suppressant medication (benzodiazepine, antihistamine, anticholinergic)
- Inability to stand or walk unassisted.
See the full eligibility criteria
- Patients receiving vestibular implants at UNIGE: Their are defined as follows:
- Deaf, scheduled for CI surgery
- Minimum of five year history of documented absence of bilateral auditory and vestibular function, based on review of their audiograms and vestibular tests.
- Vestibular testing consistent with BVL
- No neurologic disease. note: these patients are recruited and implanted by the group at the University of Geneva Hospital (UNIGE) as part of their ongoing research. The study team are not involved in any way with the...
- Vestibular patients tested at MEE: vestibular testing consistent with unilateral or bilateral vestibular damage. Both aspects of the study share the same
- Exclusion Criteria:
- No known neurologic or otologic disease other than the vestibular and auditory deficits noted above.
- Pregnancy. Pregnant women and women up to 4 months postpartum will be excluded because of the known effects and unknown potential effects of pregnancy on sensory function.
- Body weight \>250 lbs (due to motion device safety limits)
- The chronic use of vestibular suppressant medication (benzodiazepine, antihistamine, anticholinergic)
- Inability to stand or walk unassisted.
- Blindness.
- Unstable medical condition.
- Orthopedic or musculoskeletal injuries/conditions that affect gait or balance.
- Ongoing neck or spinal pain/injuries or recent history of neck or spinal surgery
- Amputation, musculoskeletal deformity, or significant leg-length discrepancy
- A history of severe head trauma.
- Any major psychiatric disorder (e.g., psychosis, schizophrenia, panic disorder), not including anxiety or depression.
- Severe heart or pulmonary conditions
- Active cancer for which chemo-/radiation therapy is being received.
The study team makes the final eligibility decision.
Where it's taking place
- Geneva, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Geneva, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.