Auditory Intranerve Stimulation Study

Auditory; Nerve Clinical Trial

— AIS  

Official title:

Intraoperative Acute Study to Evaluate Auditory Intranerve Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06306534
• Other study ID #: AIS-001
• Secondary ID: CIV-22-05-039592
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: November 15, 2024

Study information

• Verified date: February 2024
• Source: Hannover Medical School
• Contact: Karl-Heinz Dyballa
• Phone: +4917615328589
• Email: dyballa.karl-heinz[@]mh-hannover.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: November 15, 2024
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Auditory; Nerve

Intervention

Other:
• Auditory Nerve Acute (ANA) Electrode Array
To measure eABRs when stimulating the human auditory nerve

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Elicit a typical eABR Wave V with at least 0.2 µV in amplitude and a latency of the peak around 5 ms		4 weeks
Secondary	Collection of adverse events		4 weeks