Auditory Intranerve Stimulation Study

NCT ID: NCT06306534

Last Updated: 2025-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-15

Study Completion Date

2025-03-15

Brief Summary

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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.

Detailed Description

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Conditions

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Auditory; Nerve

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Insert Array Into Auditory Nerve

Group Type EXPERIMENTAL

Auditory Nerve Acute (ANA) Electrode Array

Intervention Type OTHER

To measure eABRs when stimulating the human auditory nerve

Interventions

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Auditory Nerve Acute (ANA) Electrode Array

To measure eABRs when stimulating the human auditory nerve

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Written informed consent
2. Patients who will undergo an acoustic neuroma removal surgery and are functional deaf
3. Age ≥ 18 years
4. Women with childbearing potential: willingness to use a reliable contraceptive method (e.g. copper intrauterine devices or hormonal methods) after consulting their gyncecologists

Exclusion Criteria

1. Disabilities in addition to hearing impairment which might interfere with the study procedure
2. Pregnant and breast feeding woman or other vulnerable population
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Lenarz, Prof. Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School, Director of otorhinolaryngology

Locations

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Hannover Medical School

Hanover, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Karl-Heinz Dyballa

Role: CONTACT

+4917615328589

Facility Contacts

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Karl-Heinz Dyballa

Role: primary

Other Identifiers

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CIV-22-05-039592

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AIS-001

Identifier Type: -

Identifier Source: org_study_id

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