Auditory Nerve Monitoring Using Intra-cochlear Stimulation in Subjects With Acoustic Neuroma (NeuriStim)
Primary Purpose
Hearing Loss, Cochlear, Neurinoma of the Acoustic Nerve
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neuristim
Cochlear implant
Sponsored by
About this trial
This is an interventional diagnostic trial for Hearing Loss, Cochlear
Eligibility Criteria
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
Sites / Locations
- University Hospital Bordeaux - Pellegrin
- University Hospital Grenoble - A. Michallon
- University Hospital Lyon - Edouard Herriot
- University Hospital Pitié Salpétrière
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Neuristim
Digisonic SP EVO cochlear implant
Arm Description
Electrical stimulation with the Neuristim and auditory nerve electrical response measurements (wave V).
Electrical stimulation with the patient's cochlear implant and auditory nerve electrical response measurements (wave V).
Outcomes
Primary Outcome Measures
Wave V latency
Secondary Outcome Measures
Complications
Impedance measurement
ergonomics of the Neuristim
satisfaction questionnaire
Speech audiometry
in quiet and in noise
Pure tone audiometry
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02948790
Brief Title
Auditory Nerve Monitoring Using Intra-cochlear Stimulation in Subjects With Acoustic Neuroma
Acronym
NeuriStim
Official Title
Auditory Nerve Monitoring Using Intra-cochlear Stimulation in Subjects With Acoustic Neuroma : Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
April 7, 2017 (Actual)
Primary Completion Date
April 3, 2019 (Actual)
Study Completion Date
April 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oticon Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Whatever the acoustic neuroma treatments, the patient risks a hearing loss. The global strategy of hearing care aims to preserve the quality of life and patient hearing. For severe to profound hearing loss and anatomical auditory nerve preservation, the cochlear implant is put forward compared to the auditory brainstem implant. Indeed, cochlear implant provides better speech outcomes. If cochlear implantation is not possible or no benefit for the patient, the brainstem implant is the most widely used. The Neuristim device is used to investigate the auditory nerve integrity following neuroma surgery or on an affected auditory nerve. The Neuristim is an intra-cochlear stimulator used in an intraoperative way. The intra-cochlear electrodes provide an electrical stimulation to auditory nerve fibers, and auditory nerve response measurements to these electrical stimulation are recorded and evaluated to determine the auditory nerve functionality. The Neuristim is a device for helping surgeons to choose the most appropriate implantable solution. 2 groups of patients will be involved in this study:
a group of 17 patients with an acoustic neuroma or a past neuroma surgically removed or acoustic neuroma not requiring a surgery and with severe to profound hearing loss candidate for a cochlear implant or a auditory brainstem depending on the auditory nerve functionality,
a group of 17 patients with severe to profound hearing loss candidate for a cochlear implant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Cochlear, Neurinoma of the Acoustic Nerve
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neuristim
Arm Type
Experimental
Arm Description
Electrical stimulation with the Neuristim and auditory nerve electrical response measurements (wave V).
Arm Title
Digisonic SP EVO cochlear implant
Arm Type
Active Comparator
Arm Description
Electrical stimulation with the patient's cochlear implant and auditory nerve electrical response measurements (wave V).
Intervention Type
Device
Intervention Name(s)
Neuristim
Intervention Description
Stimulation at high, medium and low intensity on apical, medial and basal Neuristim electrode
Intervention Type
Device
Intervention Name(s)
Cochlear implant
Other Intervention Name(s)
Digisonic SP EVO
Intervention Description
Stimulation at high, medium and low intensity on apical, medial and basal Cochlear implant electrode
Primary Outcome Measure Information:
Title
Wave V latency
Time Frame
perioperatively
Secondary Outcome Measure Information:
Title
Complications
Time Frame
perioperatively, 15 days postoperatively
Title
Impedance measurement
Time Frame
perioperatively
Title
ergonomics of the Neuristim
Description
satisfaction questionnaire
Time Frame
perioperatively
Title
Speech audiometry
Description
in quiet and in noise
Time Frame
3 months postoperatively
Title
Pure tone audiometry
Time Frame
3 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Vincent, MD
Organizational Affiliation
Hospital University Lille-Roger Salengro
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Bordeaux - Pellegrin
City
Bordeaux
Country
France
Facility Name
University Hospital Grenoble - A. Michallon
City
Grenoble
Country
France
Facility Name
University Hospital Lyon - Edouard Herriot
City
Lyon
Country
France
Facility Name
University Hospital Pitié Salpétrière
City
Paris
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.oticonmedical.com
Description
oticon medical website
Learn more about this trial
Auditory Nerve Monitoring Using Intra-cochlear Stimulation in Subjects With Acoustic Neuroma
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