The evaluation of [11C]K-2 in rehabilitation process.

JRCT ID: jRCTs031180192

Registered date:06/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Cerebral infarction sequela
• Date of first enrollment: 02/03/2018
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Administration of unapproved drug

Outcome(s)

• Primary Outcome: The difference of AMPA receptor distributions after one month rehabilitation in each brain region in stroke patients.

Secondary Outcome

1)Identification of brain regions where AMPA receptor densities correlates with the degree of function recovery
2)Identification of brain regions where AMPA receptor densities before rehabilitation correlates with the degree of function recovery
3)Identification of brain regions where AMPA receptor densities after rehabilitation correlates with the degree of function recovery
4)Calculation of descriptive statistics of AMPA receptors ensities before rehabilitation in each brain region
5)Calculation of descriptive statistics of AMPA receptors ensities after rehabilitation in each brain region

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1) All patients aged between 20 and 80 years old at the onset of cerebral infarction
2) All patients transferred to the rehabilitation hospital between 7 and 60 days after the onset of cerebral infarction
3) All patients with paralysis in upper and lower limbs at the onset
4) All patients with mRS 0 or 1 before the onset of cerebral infarction
5) All patients who had the initial cerebral infarction (Regardless of asymptomatic cerebral infarction revealed by the history and MRI)
6) All patients with the Infarction at least one in corona radiata, internal capusule, and brainstem and without the concurrence infarction outside the pyramidal tract
7) All patients with necessity to admitted to rehabilitation hospital over 30 days.
8) All patients with the ability to express their participation to this trial by their own will and by their own sign. When without the ability due to their functional loss, their proxies can sign consent form

Exclude criteria

1) All patients with the psychiatric disorders which demand the administration of anti depressants such as tricyclic, tetracyclic, SSRI, SNRI and NaSSa
2) All patients with cognitive disorders; the score of Mini-Mental State Examination under 23
3) All patients who had other neurologic and spinal diseases which affect motor and sensory function in upper and lower limb.
4) All patients who participated to other clinical trial (excluded observational study) in 6 months before their consent to this trial.
5) All patients who had contraindication to MRI and/or had the specific lesion other than cerebral infarction
6) All patients with the hemodialysis treatment
7) All patients with liver dysfunction (AST over 150 IU/ml and/or ALT over 150 IU/m) in screening phase
8) All patients with renal dysfunction (eGFR over 60) in screening phase
9) All patients with current or past epilepsy
10) All patients with the administration of anti epileptic drugs
11) All patients planned to under take the constraint-induced movement therapy and rTMS therapy in their admission
12) All patients who were breast-feeding, pregnant or suspected pregnant
13) All patients who desire to be pregnant and can not contraception between the inclusion and the 2nd PET study
14) All patients judged to be unsuitable to this trial by the chief and/or other doctors in the team

Related Information

• Primary Sponsor: Tomoyuki Miyazaki
• Secondary Sponsor: takahashi takuya
• Source(s) of Monetary Support: Brain Mapping by Integrated Neurotechnologies for Disease Studies,Takeda Science Fundation,Yokohama Foundation for Advancement of Medical Science,Ministry of Education, Culture, Sports, Science and Technology,Transformative Research Areas A
• Secondary ID(s): UMIN000029952