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

JRCT ID: jRCTs031230617

Registered date:06/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with bilateral severe sensorineural hearing loss and scheduled for cochlear implant surgery
• Date of first enrollment: 06/02/2024
• Target sample size: 30
• Study type: Interventional
• Intervention(s): [11C]K-2 370MBq is administered intravenously and a PET-CT scan is performed.

Outcome(s)

• Primary Outcome: AMPA receptor density per brain voxel (SUVR) measured from [11C]K-2 PET before and after cochlear implant surgery

Secondary Outcome

(1) AMPA receptor density (SUVR) per brain voxel measured from [11C]K-2PET before cochlear implant surgery and preoperative word tone listening performance CI2004 (percent correct; monosyllable, word, sentence, monosyllable under noise).
(2) AMPA receptor density (SUVR) change per brain voxel measured from [11C]K-2PET before and after cochlear implant surgery and postoperative speech sound CI2004 (correct response rate; monosyllable, word, sentence, monosyllable under noise).
(3) AMPA receptor density (SUVR) change per brain voxel measured from [11C]K-2PET before and after cochlear implant surgery and tinnitus evaluation (THI) scores. (3) The regions of the brain that have been reported to be associated with tinnitus in previous studies (amygdala, anterior and posterior cingulate gyrus, dorsolateral prefrontal cortex, hippocampus and parahippocampal gyrus), in particular.
(4) Change in AMPA receptor density (SUVR) per brain voxel measured from [11C]K-2PET before and after cochlear implant surgery and auditory quality of life assessment (NCIQ).
(5) Change in AMPA receptor density (SUVR) per brain voxel measured from [11C]K-2PET before and after cochlear implant surgery and auditory stimulation EEG test (latency and amplitude of P1 wave and A1 wave) in the primary auditory cortex.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Abe Hiroki
• Source(s) of Monetary Support: JSPS Grants-in-Aid for Scientific Research, Takeda Foundation for Science Promotion