Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma

Vestibular Schwannoma Clinical Trial

Official title:

Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03958006
• Other study ID #: 1349609
• Status: Completed
• Phase: N/A
• Start date: December 5, 2018
• Est. completion date: January 30, 2023

Study information

• Verified date: April 2023
• Source: Ascension South East Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will address the feasibility of simultaneous cochlear implantation during resection of a vestibular schwannoma.

Description:

This is prospective study patients undergoing a translabyrinthine resection for a vestibular schwannoma with intact hearing in the contralateral ear. During surgery, simultaneous cochlear implantation will be performed if the cochlear nerve can be identified and preserved during the resection.

Relevant data to be collected will include patient demographics, details related to the vestibular schwannoma including side, size, symptoms (specifically pre-operative hearing loss, degree of tinnitus), and status of hearing in the contralateral ear. Surgical details to be recorded will include date of surgery, surgical time, and whether the cochlear nerve was identified and preserved. Details related to the post-operative course to be recorded include length of stay in the hospital, post-operative complications such as wound infection or cerebral spinal fluid (CSF) leak, and need for revision or additional procedures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients with a vestibular schwannoma undergoing a translabyrinthine resection with intact hearing in the contralateral ear

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Cochlear Implantation
• Neurilemmoma
• Neuroma, Acoustic
• Vestibular Schwannoma

Intervention

Device:
• Cochlear implant
Tumor resection with cochlear implant

Locations

Country	Name	City	State
United States	Seilesh Babu	Farmington Hills	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Ascension South East Michigan

Country where clinical trial is conducted

United States, 

References & Publications (7)

Bohr C, Muller S, Hornung J, Hoppe U, Iro H. [Hearing restoration with cochlear implants after translabyrinthine vestibular schwannoma resection]. HNO. 2017 Sep;65(9):758-765. doi: 10.1007/s00106-017-0404-2. German. — View Citation

DeHart AN, Broaddus WC, Coelho DH. Translabyrinthine vestibular schwannoma resection with simultaneous cochlear implantation. Cochlear Implants Int. 2017 Sep;18(5):278-284. doi: 10.1080/14670100.2017.1337665. Epub 2017 Jun 12. — View Citation

Dos Santos Neto PH, Zamponi JO, Hamerschmidt R, Wiemes GRM, Rassi MS, Borba LAB. Simultaneous cochlear implantation as a therapeutic option in vestibular schwannoma surgery: case report. Neurosurg Focus. 2018 Mar;44(3):E9. doi: 10.3171/2017.12.FOCUS17670. — View Citation

Hassepass F, Arndt S, Aschendorff A, Laszig R, Wesarg T. Cochlear implantation for hearing rehabilitation in single-sided deafness after translabyrinthine vestibular schwannoma surgery. Eur Arch Otorhinolaryngol. 2016 Sep;273(9):2373-83. doi: 10.1007/s00405-015-3801-8. Epub 2015 Oct 23. — View Citation

Lloyd SK, Glynn FJ, Rutherford SA, King AT, Mawman DJ, O'Driscoll MP, Evans DG, Ramsden RT, Freeman SR. Ipsilateral cochlear implantation after cochlear nerve preserving vestibular schwannoma surgery in patients with neurofibromatosis type 2. Otol Neurotol. 2014 Jan;35(1):43-51. doi: 10.1097/MAO.0000000000000185. — View Citation

Rooth MA, Dillon MT, Brown KD. Prospective Evaluation of Patients Undergoing Translabyrinthine Excision of Vestibular Schwannoma with Concurrent Cochlear Implantation. Otol Neurotol. 2017 Dec;38(10):1512-1516. doi: 10.1097/MAO.0000000000001570. — View Citation

Sanna M, Medina MD, Macak A, Rossi G, Sozzi V, Prasad SC. Vestibular Schwannoma Resection with Ipsilateral Simultaneous Cochlear Implantation in Patients with Normal Contralateral Hearing. Audiol Neurootol. 2016;21(5):286-295. doi: 10.1159/000448583. Epub 2016 Nov 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of Hearing Parameters	Audiologist assesses changes in understanding of the AzBio test (words in quiet and words in background noise) post cochlear implantation.	1 month, 3 months and 6 months postoperatively.
Primary	Measurement of Hearing Parameters	Audiologist assesses changes in understanding of 50 random consonant-nucleus-consonant sounds.	1 month, 3 months and 6 months postoperatively.
Primary	Measurement of Hearing Parameters	Audiologist assesses changes in understanding changes in understanding of Speech, Spatial and Qualities of Hearing.	1 month, 3 months and 6 months postoperatively.
Secondary	Measurement of Change of Physical Symptoms Associated with Hearing Loss	Patients will complete the Dizziness Handicap Inventory	1, 3 and 6 months postoperatively
Secondary	Assessment of Change of Physical Symptoms Associated with Hearing Loss	Patients will complete the Tinnitus Handicap Inventory	1, 3 and 6 months postoperatively
Secondary	Assessment of incision site healing	Surgeon evaluates wound hearing over 3 months	1 week, and 1 and 3 months postoperatively