Recruiting · registry status

An inner-ear implant for walking and balance

Researchers are testing an implant that stimulates the inner ear's balance system to investigate walking difficulties.

Testing a treatment or activity · Study reference: NL-OMON58400

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

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Start (reported date): 2026-01-01

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded

2026-10-11 — recruiting

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Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Ages 18 to 99 · Ask the team who can join

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Read all the rules for taking part

Sex eligibility reported by registry: Not reported

Inclusion criteria: > 18 years Eligible 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 months Balance: 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: Other medical conditions (orthopaedic or neurological) that impact gait, balance or posture; Severe cognition impairments Severe tinnitus Depression or other neuropsychiatric conditions Parkinson patients with DBS Parkinson patients with a cochlear implant

Full study name & original research details

Official study title

Evaluation of electrical otolith stimulation on problems concerning gait, balance and postural stability in patients with Parkinson’s disease - VICI Parkinson

Short title used by the registry

Study on how stimulation of the organ of balance help people with Parkinson’s disease to walk better

Original description

Intervention: 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, who were also cochlear implant candidates. Measurements will be done during OFF dopaminergic state and with implant on and off at a randomized order. Assessments include gait and balance tests (MiniBEST, IMUs, CoP), vestibular function tests (VEMPs, caloric, vHIT, rotatory chair, SVV), audiometry and speech recognition, imaging (MRI, high resolution CT scan) and patient-reported outcome measures (DHI, PDQ-39, HUI-3, NCIQ, SSQ12). Primary outcome: 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 outcome: 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)

Conditions reported: Parkinson's disease Parkinson's disease;10028037;10022396;10019190

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

NL-OMON · NL-OMON58400 ↗ — Recruiting; WHO ICTRP processed 2026-09-07; checked 2026-10-13

Study type: Interventional
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, who were also cochlear implant candidates. Measurements will be done during OFF dopaminergic state and with implant on and off at a randomized order. Assessments include gait and balance tests (MiniBEST, IMUs, CoP), vestibular function tests (VEMPs, caloric, vHIT, rotatory chair, SVV), audiometry and speech recognition, imaging (MRI, high resolution CT scan) and patient-reported outcome measures (DHI, PDQ-39, HUI-3, NCIQ, SSQ12).
Phases: NA
Sponsor: Radboud Universitair Medisch Centrum
Start date reported by registry: 2026-01-01 (reported)

Registry updated: Not reported · Status last verified by the registry submitter: Not reported

Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

E.A.M Mylanus · +31611513039 · Emmanuel.Mylanus@radboudumc.nl

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Facility not reported

Netherlands

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.