UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029952 |
|---|---|
| Receipt number | 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 | 2021/11/18 10:39:37 |
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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 | 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
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
akane@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034212
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