Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma

NCT03958006 | Completed FDA Device

• 1 other identifier: 1349609
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vestibular Schwannoma; Cochlear Implantation

Outcome Measures

Primary Outcomes (3)

• 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.

• Measurement of Hearing Parameters

  Audiologist assesses changes in understanding of 50 random consonant-nucleus-consonant sounds.

  1 month, 3 months and 6 months postoperatively.

• 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 Outcomes (3)

• Measurement of Change of Physical Symptoms Associated with Hearing Loss

  1, 3 and 6 months postoperatively

• Assessment of Change of Physical Symptoms Associated with Hearing Loss

  1, 3 and 6 months postoperatively

• Assessment of incision site healing

  1 week, and 1 and 3 months postoperatively

Study Arms (1)

Cochlear implantation

EXPERIMENTAL

Simultaneous cochlear implantation with tumor resection

Device: Cochlear implant

Interventions

Cochlear implant DEVICE

Tumor resection with cochlear implant

Cochlear implantation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Seilesh Babu

Farmington Hills, Michigan, 48334, United States

Location

Related Publications (7)

• 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.

  PMID: 29490548 BACKGROUND

• 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.

  PMID: 24335931 BACKGROUND

• 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.

  PMID: 28819872 BACKGROUND

• 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.

  PMID: 26498948 BACKGROUND

• 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.

  PMID: 28602150 BACKGROUND

• 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.

  PMID: 27816972 BACKGROUND

• 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.

  PMID: 29099442 BACKGROUND

MeSH Terms

Conditions

Neuroma, Acoustic

Interventions

Cochlear Implants

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids

Study Officials

• Seilish Babu, MD

  Michigan Ear Institute, Farmington Hills, MI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: May 21, 2019
• Study Start: December 5, 2018
• Primary Completion: January 30, 2023
• Study Completion: January 30, 2023
• Last Updated: April 20, 2023

Record last verified: 2023-04

Locations

US (1)