JPRN-jRCTs031230617招募中Unknown
Exploratory Study of Brain AMPA Receptor Expression Changes Using [11C]K-2 PET Imaging in Adults with Bilateral Severe Sensorineural Hearing Loss Candidates for Cochlear Implantation Before and After Surgery - AMPA-PET to Cochlear Implant Patients
Abe Hiroki0 个研究点目标入组 30 人开始时间: 2024年2月6日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(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
排除标准
- •(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
研究者
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