Exploratory Study on Measuring Amount of Brain AMPA Receptor Before and After Cochlear Implantatio

Not Applicable

Recruiting

• Conditions: Patients with bilateral severe sensorineural hearing loss and scheduled for cochlear implant surgery; Bilateral Sever Hearing Loss, Cochlear Implant

• Registration Number: JPRN-jRCTs031230617
• Lead Sponsor: Abe Hiroki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-06
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

(1) Male and female native speakers of Japanese who are 18 years of age or older at the time of registration
(2) Patients who meet the Adult Cochlear Implant Indication Criteria (2017) specified by the Japanese Society of Otolaryngology-Head and Neck Surgery, who are judged to be eligible for cochlear implant surgery at each institution, and who are already scheduled for initial cochlear implant surgery on either one side.
(3) Patients who meet the Guidelines for the Use of Residual Hearing EAS (electric acoustic stimulation) established by the Japanese Society of Otolaryngology, Head and Neck Surgery, who are judged to be eligible for EAS, and who are scheduled for initial EAS cochlear implant surgery on either one side at each co-institution.
Patients who have undergone initial surgery on either one of the left or right side as in (1) above.
(4) Patients who give written consent to participate in this study

Exclusion Criteria

(1) Patients who cannot undergo head MRI imaging due to metallic substances implanted in the body (pacemakers, deep brain stimulators, etc.)
(2) Patients with severe claustrophobia who are unable to enter the MRI scanner
(3) Patients with tattoos or art makeup that the principal investigator or subinvestigator determines to be dangerous for MRI imaging
(4) Pregnant, lactating, or wishing to become pregnant during the period of study participation
(5) Patients who are hypersensitive to alcohol
(6) Patients with a blood test result of 75 IU/L (2.5 times the reference value) or higher for either AST or ALT, or a serum Cr of 2.0 mg/dl or higher
(7) Patients with a history of neurosurgery or scheduled to undergo neurosurgery during the period of participation in this study
(8) Patients with significant malformation (congenital or traumatic) of brain structures
(9) Patients with a history of dementia who have difficulty making their own decision to participate in the study (Raven Color Matrix test result of less than 18 points after obtaining consent27)
(10) Patients who need to continue taking perampanel (antiepileptic drug) or topiramate (antiepileptic drug)
(11) Patients who may receive unapproved treatments or tests in other clinical trials or clinical studies during the period of participation in this study
(12) Patients who already have a cochlear implant on the opposite side of the operative side
(13)Other patients deemed inappropriate as research subjects by the principal investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AMPA receptor density per brain voxel (SUVR) measured from [11C]K-2 PET before and after cochlear implant surgery