UMIN-CTR Clinical Trial

Basic information
Public title	The exploratory clinical trial to evaluate the efficacy of [11C]K-2 in stroke patients under rehabilitation.
Acronym	The evaluation of [11C]K-2 in rehabilitation process.
Scientific Title	The exploratory clinical trial to evaluate the efficacy of [11C]K-2 in stroke patients under rehabilitation.
Scientific Title:Acronym	The evaluation of [11C]K-2 in rehabilitation process.
Region	Japan

Condition
Condition	Cerebral infarction sequela
Classification by specialty	Neurology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of [11C]K-2 in rehabilitation practice, the association between the functional recovery and the distribution of AMPA receptors in the brain in stroke patients under rehabilitation will be acquired.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The difference of AMPA receptor distributions after one month rehabilitation in each brain region in stroke patients.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Rehabilitation for 28 days
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion 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
Key exclusion 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
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Tomoyuki Middle name Last name Miyazaki
Organization	Yokohama City University hospital
Division name	Department of Physiology /Anesthesiology
Zip code	2360004
Address	3-9 Fukuura, Kanazawa-ward, Yokohama 236-0004
TEL	045-787-2579
Email	johney@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Akane Middle name Last name Sano
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Physiology
Zip code	2360004
Address	3-9 Fukuura, Kanazawa-ward, Yokohama 236-0004
TEL	045-787-2579
Homepage URL
Email	akane@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Yokohama Brain and Spine Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama City University Certified Institutional Review Board
Address	3-9 Fukuura Kanazawa Yokohama, Kanagawa, Japan
Tel	045-370-7627
Email	ycu_crb@yokohama-cu.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 04 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 06 Day
Date of IRB	2017 Year 10 Month 05 Day
Anticipated trial start date	2018 Year 01 Month 10 Day
Last follow-up date	2020 Year 03 Month 19 Day
Date of closure to data entry	2020 Year 09 Month 25 Day
Date trial data considered complete	2020 Year 09 Month 28 Day
Date analysis concluded	2020 Year 10 Month 19 Day

Other
Other related information

Management information
Registered date	2017 Year 11 Month 13 Day
Last modified on	2021 Year 11 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034212