JPRN-jRCTs031220728招募中Unknown
Exploratory study to compare AMPA receptors changes during rehabilitation with or without T-817MA measured with [11C]K-2 PET combined with Japic-104711 data - Additional T-817 AMPA-PET
Abe Hiroki0 个研究点目标入组 2 人开始时间: 2023年3月24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
- 2
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
- >= 20age old 至 < 85age old（—）
- 性别
- All
入选标准
- •(1) Males and females aged 20 to 85 at the time of informed consent
- •(2) Japanese living in Japan
- •(3) Patients diagnosed with first-onset stroke (excluding subarachnoid hemorrhage) by MRI or CT (Patients with a history of transient ischemic attack and asymptomatic cerebral infarction are eligible for inclusion)
- •(4)Patients who can undergo the first AMPA-PET imaging within 22 to 56 days after stroke onset as day 1.
- •(5) Patients with unilateral upper limb paralysis and a total FMA (upper limb motor function) score of 47 or less on the paralyzed side
- •(6) Patients who can be hospitalized and undergo rehabilitation after obtaining consent until the second AMPA-PET imaging
- •(7) Patients who can obtain written informed consent to participate in this study from themselves. It is possible to have a fair witness as a third party who agrees to participate in.
排除标准
- •(1) Patients who cannot answer questions 1) or 2) below or respond to instructions 3) or 4)
- •1) Month name of the month, 2) Age, 3) Eyes open and closed, 4) Hands-off handshake on healthy side
- •(2) Severe higher brain dysfunction, severe sensory disturbance, depression, cognitive dysfunction such as schizophrenia, and psychiatric disorders patient
- •(3) Patients with pain in the upper extremities that disturbs sleep
- •(4) Patients unable to jointly move the upper extremities or collectively flex the fingers
- •(5) Patients with a baseline FMA increase of 1 point or less or 9 points or more from the screening FMA value
- •(6) Hepatic dysfunction (either AST, ALT, or ALP >= 2.5 times the upper limit of institutional reference) or renal dysfunction (serum Cr is 2.0 mg/dl or higher)
- •(7) Complications that make rehabilitation difficult for the upper extremities (severe heart disease, uncontrolled hypertension, pulmonary embolism, severe orthopedic disease)
- •(8) Patients with a history or complication of epilepsy
- •(9) Patients taking perampanel or topiramate (drugs with AMPA receptor antagonism)
- •(10) Patients who developed convulsions after stroke
- •(11) Patients who are pregnant or may be pregnant
- •(12) Breast-feeding patients
- •(13) Patients who cannot actively participate in rehabilitation
- •(14) Patients who are contraindicated for MRI imaging (patients with non-MRI compatible cardiac pacemakers, dental implants, patients with non-removable metal inclusions such as tattoos, patients with severe claustrophobia) )
- •(15) Patients participating in other clinical trials/clinical studies (excluding observational studies) during the study participation period
- •(16) Patients who have participated in a clinical trial of T-817MA in the past
- •(17) Patients with alcohol hypersensitivity
- •(18) Patients who are judged to be inappropriate as research subjects by the principal investigator or subinvestigator
研究者
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