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Tests treatment safety and results for Vestibulopathy
Official title A Study to Evaluate the Safety and Performance of a Vestibular Implant in Adults to Provide Balance Restoration
ClinicalTrials.gov ID: NCT06805175
What this study is testing
- What it's testing
- The main aim of this study is to understand if an experimental vestibular implant system can improve balance performance. The system consists of a vestibular implant combined with a cochlear implant sound processor and programming software.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults of 18 years or older with bilateral vestibulopathy \>1 year of evolution without benefit from conventional rehabilitation treatment. Symptoms...
- Hearing impairment ranging from:
- Early feasibility stage (first 6 people enrolled): moderate to severe hearing loss with PTA of 41-70 dB HL on the ear to be implanted.
- Late feasibility stage (12 people): normal hearing to severe hearing loss with PTA ≤ 70 dB HL on the ear to be implanted.
- Patients diagnosed with bilateral vestibulopathy or probable bilateral vestibulopathy based on the consensus document of the Barany Society on...
You likely can't join if
- Dynamic Gait Index \> 18 and Functional Gait Assessment \> 22
- Ossification or other inner ear anomalies that prevent full insertion of electrodes.
- Middle ear disorders including conductive hearing loss.
- Retro cochlear or central origins of hearing impairment.
- Medical contraindications for surgery.
- Chronic depression, dementia and cognitive disorders that could, at the discretion of the clinician, significantly interfere with use or evaluation...
See the full eligibility criteria
- Adults of 18 years or older with bilateral vestibulopathy \>1 year of evolution without benefit from conventional rehabilitation treatment. Symptoms unlikely to improve according to clinicians´ estimation.
- Hearing impairment ranging from:
- Early feasibility stage (first 6 people enrolled): moderate to severe hearing loss with PTA of 41-70 dB HL on the ear to be implanted.
- Late feasibility stage (12 people): normal hearing to severe hearing loss with PTA ≤ 70 dB HL on the ear to be implanted.
- Patients diagnosed with bilateral vestibulopathy or probable bilateral vestibulopathy based on the consensus document of the Barany Society on vestibular implant candidate criteria for research [van de Berg et al...
- Anatomical optimal conditions for implantation evaluated by CT and MRI: vestibule permeability ascertained and present intact vestibular nerve.
- Ability to use the device and follow a personalized rehabilitation program.
- Ability to undergo the surgery.
- Dynamic Gait Index \> 18 and Functional Gait Assessment \> 22
- Ossification or other inner ear anomalies that prevent full insertion of electrodes.
- Middle ear disorders including conductive hearing loss.
- Retro cochlear or central origins of hearing impairment.
- Medical contraindications for surgery.
- Chronic depression, dementia and cognitive disorders that could, at the discretion of the clinician, significantly interfere with use or evaluation of the VI.
- Cerebellar ataxias without bilateral vestibulopathy and CANVAS.
- Known genetical indication for ataxia.
- Known diagnosis of DFNA9.
- Downbeat nystagmus syndrome.
- Persistent Postural-Perceptual Dizziness.
- Vestibular suppressant medications.
- Oculomotor disorders (if oscillopsia is prominent).
- Peripheral neuropathies.
- Central gait disorders due to normal pressure hydrocephalus, frontal gait disorders, subcortical vascular encephalopathy or multiple sclerosis.
- Intoxications (i.e. excessive alcohol and/or drugs use).
- No current psychological or psychiatric disorder that could significantly interfere with use or evaluation of the VI.
- Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent in the procedure and prosthetic device.
- Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
- Pregnant or breastfeeding women.
- Current participation, or participation in another treatment clinical study/trial in the past 30 days, involving an investigational drug or device (unless determined by the investigator or Sponsor to not impact this...
The study team makes the final eligibility decision.
Where it's taking place
- Antwerp, Wilrijk, Belgium
- Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain
- Pamplona, Navarre, Spain
Compensation & support
A stipend or compensation may be offered.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Antwerp, Wilrijk, Belgium; Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain; Pamplona, Navarre, Spain. Enter your location above to see the nearest site and check your eligibility.
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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.