Clinical trial NCT03795675: CI Following VS Removal or Labyrinthectomy
Official title: Cochlear Implantation During Vestibular Schwannoma Removal or During Labyrinthectomy Surgery for Treatment of Meniere's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vestibular Schwannoma
Meniere Disease
Keywords: Cochlear implants
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Advanced Bionics
First posted: 2019-01-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a prospective, clinical study to determine if it is safe and effective to use a cochlear implant over time in individuals undergoing removal of a vestibular schwannoma (VS), benign tumor of the hearing and balance nerve or undergoing a labyrinthectomy for treatment of Meniere's disease. Individuals undergoing these surgeries will be deaf on the surgical side after the procedure. Currently, cochlear implants are approved for use and not considered investigational in individuals with hearing loss on both sides. However, use of a cochlear implant for these patient populations (single-sided hearing loss) will be considered a new use of an approved device. Participants undergoing surgery to remove a VS or having a labyrinthectomy will have a cochlear implant inserted after the surgical procedure for clinical care. Approximately 4 weeks after surgery, participants will be fitted with an external speech processor on the surgical side that will stimulate the internal cochlear implant. Participants will return at the following intervals after the initial processor fitting: 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months. At each interval, participants will complete questionnaires on how they are hearing with the implant and their quality of life with the implant and be tested on their ability to hear sounds and understand speech. Potential risks are those associated with all cochlear implant surgeries, and include device failure resulting in removal of device, irritation or redness in surgical area and/or area where processor is attached, increased ringing in the ear, facial nerve stimulation and a change in the way speech and other sounds sound through the implant. Potential benefits to individual participants in this study include improvement in detection and speech understanding of the surgical ear. Participants may also experience improved abilities to locate sound and understand speech in noise as the result of having hearing on both sides.


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of a vestibular schwannoma confirmed by a physician with an MRI and/or CT scan; Or have a diagnosis of Meniere's disease by a physician
* Be scheduled to undergo surgery to remove the vestibular schwannoma through translabyrinthine approach; Or be scheduled to undergo a labyrinthectomy
* Be English-speaking due to objective speech perception tasks. Non-English speakers may show a reduced speech perception score due to language differences
* For patients undergoing tumor removal, tumor removal must allow preservation of the auditory division of the VIIIth cranial nerve

Exclusion Criteria:

* Subjects with bilateral Meniere's disease or bilateral vestibular schwannomas
* Inability to preserve the auditory division of the VIIIth cranial nerve during removal of vestibular schwannoma
* Ossification or fibrosis of the cochlear found on preoperative imaging (CT or MRI) that precludes cochlear implantation
* Active middle ear disease
* Greater than 70 years of age
* Vestibular schwannoma greater than 2 cm
* Patient refusal of receiving pneumococcal vaccine
* Any contra-indication(s) for undergoing surgery.

Primary outcomes:
measure: Change in Sound Detection Testing
timeFrame: Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation.
measure: Change in Speech Perception Testing
timeFrame: Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation.
measure: Change in Sound Localization Testing
timeFrame: Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation.
Secondary outcomes:
measure: Change in Speech, Spatial and Qualities of Hearing Scale (SSQ) Scores
timeFrame: Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation.
measure: Change in Nijmegen Cochlear Implant Questionnaire (NCIQ) Scores
timeFrame: Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation.
measure: Change in Tinnitus Handicap Inventory (THI) Scores
timeFrame: Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation.
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Oliver Adunka, MD
role: PRINCIPAL_INVESTIGATOR
References: