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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029952
Receipt No. R000034212
Scientific Title The exploratory clinical trial to evaluate the efficacy of [11C]K-2 in stroke patients under rehabilitation.
Date of disclosure of the study information 2018/01/04
Last modified on 2018/03/02

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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
Middle name
Last name Tomoyuki Miyazaki
Organization Yokohama City University hospital
Division name Department of Physiology /Anesthesiology
Zip code
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
Middle name
Last name Hideki Arakawa
Organization Yokohama City University hospital
Division name Department of Rehabilitation
Zip code
Address 3-9 Fukuura, Kanazawa-ward, Yokohama 236-0004
TEL 045-787-2579
Homepage URL
Email anju3130@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
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 Enrolling by invitation
Date of protocol fixation
2017 Year 10 Month 06 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 13 Day
Last modified on
2018 Year 03 Month 02 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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