Vestibular implant to restore balance in adults

A Prospective, Multicentric, Staged Feasibility Study to Evaluate the Safety and Performance of the Second-generation Otolith Vestibular Implant in Adults With Vestibular Dysfunction to Mitigate Imbalance. BionicVEST2

This study will test whether an experimental vestibular implant paired with a cochlear sound processor can improve balance in adults with long-standing bilateral vestibulopathy and normal to severe hearing loss.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cochlear (Industry-sponsored)
• Locations: 3 sites (Antwerp, Wilrijk and 2 other locations)
• Trial ID: NCT06805175 on ClinicalTrials.gov

What this trial studies

The device is an experimental vestibular implant surgically placed under the skin behind the ear with an electrode that stimulates the vestibular nerve and a behind-the-ear sound processor that powers the implant. It is designed to preserve hearing in the implanted ear while delivering vestibular stimulation. Adults with chronic bilateral vestibulopathy and a range of hearing from normal to severe will undergo implantation and regular follow-up. Participants will complete objective balance and hearing tests plus self-reported questionnaires to track safety and functional change over time.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 or older with bilateral vestibulopathy for more than one year who have not benefited from conventional rehabilitation and who meet the study's hearing thresholds for the ear to be implanted.

Not a fit: People whose balance problems are primarily due to non-vestibular causes, who have fluctuating vestibular disease, or whose hearing is worse than the study's allowed limit may not receive benefit.

Why it matters

Potential benefit: If successful, the implant could improve balance, reduce falls, and improve daily function while preserving hearing in the implanted ear.

How similar studies have performed: Early feasibility reports and small case series of vestibular implants have shown promise, but larger controlled data remain limited.

Eligibility criteria

Inclusion 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:

  1. Early feasibility stage (first 6 subjects enrolled): moderate to severe hearing loss with PTA of 41-70 dB HL on the ear to be implanted.
  2. Late feasibility stage (12 subjects): 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 \[van de Berg et al., 2020\]:

  a. Unsteadiness when walking or standing plus at least one of the following: i. Movement-induced blurred vision or ii. Oscillopsia during walking or quick head/body movements, and/or iii. Worsening of unsteadiness in darkness and/or on uneven ground b. Symptoms greatest during head movement and not compensated after rehabilitation program. c. Bilaterally reduced or absent angular VOR function documented by at least one of the following major criteria: i. Pathological horizontal angular VOR gain ≤ 0.6 and at least one vertical angular VOR gain \< 0.7, measured by the video-HIT technique. ii. Reduced caloric response (sum of bithermal max. peak SPV on each side ≤6◦/sec for 30 sec water stimuli or \<10◦/sec for 60 sec of air stimuli). In case only one of two criteria from c. are matched, the remaining test(s) should comply with the following minor criteria: 1) Bilaterally pathological VOR gains of at least two semicircular canals \< 0.7, measured by the video- HIT or scleral-coil technique 2) Reduced caloric response (sum of bithermal max. peak SPV on each side \<10°/sec for water and air stimuli of ≥30 sec). d. Absent cVEMP and oVEMP responses in the ear to be implanted.
* 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.

Exclusion Criteria:

* 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 interventional 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 investigation).

Where this trial is running

Antwerp, Wilrijk and 2 other locations

• ZAS Augustinus — Antwerp, Wilrijk, Belgium (Recruiting)
• C.H.U. Insular & Materno-Infantil Hospital.(SCS) Las Palmas University. (ULPGC) — Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain (Recruiting)
• Clinica Universitad de Navarra (CUN) — Pamplona, Navarre, Spain (Recruiting)

Study contacts

• Study coordinator: PRS Specialist

Conditions Vestibulopathy; Moderate to Severe Hearing Loss; Normal Hearing; Balance Deficits; Vestibular Abnormality; vestibular implant; vestibulopathy; cochlear implant