Parkinson's disease Parkinson's disease
Conditions
Interventions
All enrolled participants receive a modified cochlear-vestibular implant (BionicVEST2) targeting the otolith organ. The proposed technology has been already tested in bilateral vestibulopathy patients
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: > 18 yearsEligible for surgery Hearing status: the patients are eligible for unilateral cochlear implantation, in accordance with the Dutch CI guidelines (CI Veldnorm, revised 2022). Although not mandatory, a preference for the presence of residual hearing (PTA<80dB at lower frequencies, 500 Hz and 1kHz) in order to evaluate the effect of vestibular insertion on residual hearing.Parkinson disease diagnosis: · HY2.5 – HY3 (balance impairments present)Stable levels of dopaminergic medications in the last 6 monthsBalance: the patient should show functional balance impairment (Mini-BEST scoring 24 points or lower). Participants should have significantly impaired or absent vestibular function demonstrated by pathological VEMPs. Vestibulo-ocular reflexes (VOR) may be pathological but not mandatory.Patients must be fluent in Dutch (read and comprehend PIFs, participate in speech tests).
Exclusion criteria
Exclusion criteria: Other medical conditions (orthopaedic or neurological) that impact gait, balance or posture;Severe cognition impairments Severe tinnitusDepression or other neuropsychiatric conditionsParkinson patients with DBSParkinson patients with a cochlear implant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effect of the electrical stimulation of the otolith organ on gait, balance, and posture performance in the dopaminergic OFF-state, by comparing effect from baseline to 6 weeks and 12 months, and short-term effect of the same visit (on/off implant activation). | — |
Secondary
| Measure | Time frame |
|---|---|
| The assessment of safety; registration of adverse events during follow-up visits; The effects of placement of the VI electrode on residual hearing and vestibular function (during surgery, 6 weeks and 12 months) | — |
Countries
Netherlands
Contacts
Public ContactE.A.M Mylanus
Radboud Universitair Medisch Centrum
Outcome results
None listed