Hearing Loss, CochlearNeuriStimNCT02948790
Auditory Nerve Monitoring Using Intra-cochlear Stimulation in Subjects With Acoustic Neuroma
A study testing Neuristim and Cochlear implant in people with Hearing Loss, Cochlear and Neurinoma of the Acoustic Nerve, run by Oticon Medical at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Cochlear, Neurinoma of the Acoustic Nerve
- What is being tested?
- Neuristim and Cochlear implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 4 sitesFrance
- Study dates
- 7 Apr 2017to 3 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Cochlea malformation, cochlea ossification
- Vulnerable subject
Trial locations and contacts
4 sites in 1 country.
France4 sites
University Hospital Bordeaux - Pellegrin
Bordeaux
University Hospital Grenoble - A. Michallon
Grenoble
University Hospital Lyon - Edouard Herriot
Lyon
University Hospital Pitié Salpétrière
Paris
About this study
Official title: Auditory Nerve Monitoring Using Intra-cochlear Stimulation in Subjects With Acoustic Neuroma : Feasibility Study
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.
Read the 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.
- Being tested
- Neuristim, Cochlear implant
- Medical subject headings
- Hearing Loss, Sensorineural, Neuroma, Acoustic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuristimDevice
Stimulation at high, medium and low intensity on apical, medial and basal Neuristim electrode
Cochlear implantDevice
Also called Digisonic SP EVO
Stimulation at high, medium and low intensity on apical, medial and basal Cochlear implant electrode
| Study group | Role | What they receive |
|---|---|---|
| Neuristim | Experimental | Electrical stimulation with the Neuristim and auditory nerve electrical response measurements (wave V). Receives: Device: Neuristim |
| Digisonic SP EVO cochlear implant | Active comparator | Electrical stimulation with the patient's cochlear implant and auditory nerve electrical response measurements (wave V). Receives: Device: Cochlear implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wave V latency
Measured: perioperatively
Secondary outcomes (5)
Complications
Measured: perioperatively, 15 days postoperatively
Impedance measurement
Measured: perioperatively
ergonomics of the Neuristim
satisfaction questionnaire
Measured: perioperatively
Speech audiometry
in quiet and in noise
Measured: 3 months postoperatively
Pure tone audiometry
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study start7 Apr 2017
- Primary completion3 Apr 2019
- Study completion3 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, CochlearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christophe Vincent, MD, Principal investigator, Hospital University Lille-Roger Salengro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948790
- Sponsor's protocol ID
- PIC_05
- Acronym
- NeuriStim
- Status last verified
- Oct 2021
- First submitted
- 26 Oct 2016
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auditory Nerve Monitoring Using Intra-cochlear Stimulation in Subjects With Acoustic Neuroma : Feasibility Study
- ClinicalTrials.gov ID
- NCT02948790
- Acronym / sponsor ID
- NeuriStim / PIC_05
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- 3 Apr 2019 (actual)
- Study completion
- 3 Apr 2019 (actual)
- First posted
- 28 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuristim | Experimental | Device: NeuristimElectrical stimulation with the Neuristim and auditory nerve electrical response measurements (wave V). |
| Digisonic SP EVO cochlear implant | Active comparator | Device: Cochlear implantElectrical stimulation with the patient's cochlear implant and auditory nerve electrical response measurements (wave V). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- Cochlea malformation, cochlea ossification
- Vulnerable subject
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuristimStimulation at high, medium and low intensity on apical, medial and basal Neuristim electrode | Device | Neuristim |
| Cochlear implantAlso: Digisonic SP EVOStimulation at high, medium and low intensity on apical, medial and basal Cochlear implant electrode | Device | Digisonic SP EVO cochlear implant |
Primary outcome
Wave V latency
Time frame: perioperatively
5 secondary outcomes
Complications
Time frame: perioperatively, 15 days postoperatively
Impedance measurement
Time frame: perioperatively
ergonomics of the Neuristim
Time frame: perioperatively
Speech audiometry
Time frame: 3 months postoperatively
Pure tone audiometry
Time frame: 3 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- oticon medical websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe Vincent, MD principal investigator
Hospital University Lille-Roger Salengro
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuristim and Cochlear implant in people with Hearing Loss, Cochlear and Neurinoma of the Acoustic Nerve, run by Oticon Medical at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wave V latency (time frame: perioperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.