UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034303
Receipt number R000039106
Scientific Title Relationship between NMDA-R related amino acids and stroke recovery
Date of disclosure of the study information 2018/09/27
Last modified on 2018/09/27 22:30:20

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Basic information

Public title

Relationship between NMDA-R related amino acids and stroke recovery

Acronym

NMDA-R related amino acids and stroke recovery

Scientific Title

Relationship between NMDA-R related amino acids and stroke recovery

Scientific Title:Acronym

NMDA-R related amino acids and stroke recovery

Region

Japan


Condition

Condition

stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Our purpose was to investigate the effects of rTMS on serum levels of NMDAR-related amino acids in post-stroke patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

change of serum levels of NMDAR-related amino acids

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

rehabilitation with repetitive transcranial magnetic stmulation(2weeks)

Interventions/Control_2

rehabilitation without repetitive transcranial magnetic stmulation(2weeks)

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

30 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Age at intervention of 30-90 years.
2) Time after onset of stroke >1 month.
3) Mild or moderate upper limb hemiparesis
4) At a probable plateau state with regard to recovery of upper limb hemiparesis
5) No cognitive deficits
6) No history of convulsions.
7) No intracranial metal or cardiac pacemaker.

Key exclusion criteria

1) Unacceptable quality of blood samples collected from the patients
2) missing values of clinical evaluation before and/or after intervention.

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masachika Niimi

Organization

The Jikei University School of Medicine

Division name

Department of Rehabilitation

Zip code


Address

3-25-8, Nishi-Shimbashi, Minato-Ku, Tokyo

TEL

03-3433-1111

Email

pomardon2010@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Masachika Niimi

Organization

The Jikei University School of Medicine

Division name

Department of Rehabilitation

Zip code


Address

3-25-8, Nishi-Shimbashi, Minato-Ku, Tokyo

TEL

03-3433-1111

Homepage URL


Email

pomardon2010@gmail.com


Sponsor or person

Institute

The Jikei University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

This work was supported by JSPS KAKENHI Grant Number 17K13070.

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 09 Month 27 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

2011 Year 12 Month 05 Day

Date of IRB


Anticipated trial start date

2012 Year 02 Month 01 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

2018 Year 09 Month 27 Day

Last modified on

2018 Year 09 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039106


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name