Auditory; NerveAISNCT06306534
Auditory Intranerve Stimulation Study
A study testing Auditory Nerve Acute (ANA) Electrode Array in people with Auditory; Nerve, run by Hannover Medical School at 1 site in Germany.
Trial summary
This feasibility clinical investigation is designed to answer the question of whether auditory brainstem responses can be safely elicited by acute electrical stimulation within the human auditory nerve. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Auditory; Nerve
- What is being tested?
- Auditory Nerve Acute (ANA) Electrode Array
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 15 May 2023to 15 Mar 2025
- 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
- Written informed consent
- Patients who will undergo an acoustic neuroma removal surgery and are functional deaf
- Age ≥ 18 years
- Women with childbearing potential: willingness to use a reliable contraceptive method (e.g. copper intrauterine devices or hormonal methods) after consulting their gyncecologists
Who cannot join
- Disabilities in addition to hearing impairment which might interfere with the study procedure
- Pregnant and breast feeding woman or other vulnerable population
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Hannover Medical School
Hanover, 30625
Karl-Heinz Dyballa, dyballa.karl-heinz@mh-hannover.de
About this study
Official title: Intraoperative Acute Study to Evaluate Auditory Intranerve Stimulation
This feasibility clinical investigation is designed to answer the question of whether auditory brainstem responses can be safely elicited by acute electrical stimulation within the human auditory nerve.
- Conditions
- Auditory; Nerve
- Being tested
- Auditory Nerve Acute (ANA) Electrode Array
- Medical subject headings
- Vestibulocochlear Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory Nerve Acute (ANA) Electrode ArrayOther
To measure eABRs when stimulating the human auditory nerve
| Study group | Role | What they receive |
|---|---|---|
| Insert Array Into Auditory Nerve | Experimental | Not described Receives: Other: Auditory Nerve Acute (ANA) Electrode Array |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elicit a typical eABR Wave V with at least 0.2 µV in amplitude and a latency of the peak around 5 ms
Measured: 4 weeks
Secondary outcomes (1)
Collection of adverse events
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start15 May 2023
- Primary completion15 Mar 2025 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auditory; NerveStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Lenarz, Prof. Prof. Dr., Principal investigator, Hannover Medical School, Director of otorhinolaryngology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306534
- Sponsor's protocol ID
- AIS-001
- Other IDs
- CIV-22-05-039592
- Acronym
- AIS
- Status last verified
- Feb 2024
- First submitted
- 28 Feb 2024
- Last updated
- 15 Jan 2025
- 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 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Acute Study to Evaluate Auditory Intranerve Stimulation
- ClinicalTrials.gov ID
- NCT06306534
- Acronym / sponsor ID
- AIS / AIS-001
- Conditions
- Auditory; Nerve
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 12 Mar 2024 (actual)
- 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.
This feasibility clinical investigation is designed to answer the question of whether auditory brainstem responses can be safely elicited by acute electrical stimulation within the human auditory nerve.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insert Array Into Auditory Nerve | Experimental | Other: Auditory Nerve Acute (ANA) Electrode Array |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent
- Patients who will undergo an acoustic neuroma removal surgery and are functional deaf
- Age ≥ 18 years
- Women with childbearing potential: willingness to use a reliable contraceptive method (e.g. copper intrauterine devices or hormonal methods) after consulting their gyncecologists
Key exclusion criteria (2 listed)
- Disabilities in addition to hearing impairment which might interfere with the study procedure
- Pregnant and breast feeding woman or other vulnerable population
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 |
|---|---|---|
| Auditory Nerve Acute (ANA) Electrode ArrayTo measure eABRs when stimulating the human auditory nerve | Other | Insert Array Into Auditory Nerve |
Primary outcome
Elicit a typical eABR Wave V with at least 0.2 µV in amplitude and a latency of the peak around 5 ms
Time frame: 4 weeks
1 secondary outcome
Collection of adverse events
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- 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.
Thomas Lenarz, Prof. Prof. Dr. principal investigator
Hannover Medical School, Director of otorhinolaryngology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory Nerve Acute (ANA) Electrode Array in people with Auditory; Nerve, run by Hannover Medical School at 1 site in Germany.
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 4 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: status not confirmed, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karl-Heinz Dyballa (+4917615328589, dyballa.karl-heinz@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elicit a typical eABR Wave V with at least 0.2 µV in amplitude and a latency of the peak around 5 ms (time frame: 4 weeks). 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 15 Jan 2025.