Auditory Nerve Monitoring Using Intra-cochlear Stimulation in Subjects With Acoustic Neuroma
NeuriStim
1 other identifier
interventional
17
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2017
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2016
CompletedFirst Posted
Study publicly available on registry
October 28, 2016
CompletedStudy Start
First participant enrolled
April 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 3, 2019
CompletedOctober 20, 2021
October 1, 2021
2 years
October 26, 2016
October 13, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Wave V latency
perioperatively
Secondary Outcomes (5)
Complications
perioperatively, 15 days postoperatively
Impedance measurement
perioperatively
ergonomics of the Neuristim
perioperatively
Speech audiometry
3 months postoperatively
Pure tone audiometry
3 months postoperatively
Study Arms (2)
Neuristim
EXPERIMENTALElectrical stimulation with the Neuristim and auditory nerve electrical response measurements (wave V).
Digisonic SP EVO cochlear implant
ACTIVE COMPARATORElectrical stimulation with the patient's cochlear implant and auditory nerve electrical response measurements (wave V).
Interventions
Stimulation at high, medium and low intensity on apical, medial and basal Neuristim electrode
Stimulation at high, medium and low intensity on apical, medial and basal Cochlear implant electrode
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Cochlea malformation, cochlea ossification
- Vulnerable subject
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oticon Medicallead
Study Sites (4)
University Hospital Bordeaux - Pellegrin
Bordeaux, France
University Hospital Grenoble - A. Michallon
Grenoble, France
University Hospital Lyon - Edouard Herriot
Lyon, France
University Hospital Pitié Salpétrière
Paris, France
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christophe Vincent, MD
Hospital University Lille-Roger Salengro
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2016
First Posted
October 28, 2016
Study Start
April 7, 2017
Primary Completion
April 3, 2019
Study Completion
April 3, 2019
Last Updated
October 20, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share