Clinical trial · Interventional
Auditory Nerve Monitoring Using Intra-cochlear Stimulation in Subjects With Acoustic Neuroma
Auditory Nerve Monitoring Using Intra-cochlear Stimulation in Subjects With Acoustic Neuroma : Feasibility Study
NCT02948790CI-TRIAL-00054577NeuriStimcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to assess the auditory nerve functionality with an intraoperative approach following a surgical removal of acoustic neuroma in patients with severe to profound sensorineural hearing disabilities.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hearing Loss, Cochlear | — | UNRESOLVED | — |
| Neurinoma of the Acoustic Nerve | Vestibular Schwannoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cochlear implant | Device | — | UNRESOLVED |
| Neuristim | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Neuristim
- description
- Electrical stimulation with the Neuristim and auditory nerve electrical response measurements (wave V).
- interventionNames
- Device: Neuristim
- type
- ACTIVE_COMPARATOR
- label
- Digisonic SP EVO cochlear implant
- description
- Electrical stimulation with the patient's cochlear implant and auditory nerve electrical response measurements (wave V).
- interventionNames
- Device: Cochlear implant
Primary outcomes (1)
- measure
- Wave V latency
- timeFrame
- perioperatively
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must be 18 years or older * Patient with an acoustic neuroma already surgically removed with associated hearing loss (experimental group), * Patient with an acoustic neuroma programmed to be surgically removed and candidates for an implantable hearing rehabilitation solution (experimental group), * Patient with an acoustic neuroma that not need to be removed and candidate for an implantable hearing rehabilitation solution (experimental group), or * Typical patient candidate for a cochlear implant (control group) Exclusion Criteria: * Cochlea malformation, cochlea ossification * Vulnerable subject
References
Publications (0)
Data not yet available
No reference posted for this study.