UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017137
Receipt number R000019876
Scientific Title Study of combined effect of repetitive transcranial magnetic stimulation and intensive rehabilitation for post-stroke patients
Date of disclosure of the study information 2015/04/20
Last modified on 2019/04/26 10:35:56

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Basic information

Public title

Study of combined effect of repetitive transcranial magnetic stimulation and intensive rehabilitation for post-stroke patients

Acronym

rTMS and intensive rehabilitation

Scientific Title

Study of combined effect of repetitive transcranial magnetic stimulation and intensive rehabilitation for post-stroke patients

Scientific Title:Acronym

rTMS and intensive rehabilitation

Region

Japan


Condition

Condition

Patients with upper limb paralysis or aphasia due to post-stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the combined effect of repetitive transcranial magnetic stimulation and intensive rehabilitation

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Wolf Motor Function Test(WMFT), Motor Activity Log(MAL) etc. for upper limb paralysis
Standard Language Test of Aphasia (SLTA) for aphasia

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

Device,equipment

Interventions/Control_1

repetitive transcranial magnetic stimulation: 1Hz,2400pulses/day,10days
intensive rehabilitation: 5hour/day,10days

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

18 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

1. upper limb paralysis or aphasia due to stroke
2. over 6 months after stroke

Key exclusion criteria

1. dementia
2. depression
3. dialysis
4. intracranial metal
5. history of seizures within a year
6. pregnancy
7. a serious medical condition
8. level of dependence in activities of daily living

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Yasutaka
Middle name
Last name Kobayashi

Organization

Fukui General Hospital

Division name

Department of Rehabilitation Medicine

Zip code

910-8561

Address

58-16-1, Egami-cho, Fukui-shi, Fukui, JAPAN

TEL

0776591300

Email

yasutaka_k@mri.biglobe.ne.jp


Public contact

Name of contact person

1st name Yasutaka
Middle name
Last name Kobayashi

Organization

Fukui General Hospital

Division name

Department of Rehabilitation Medicine

Zip code

910-8561

Address

58-16-1, Egami-cho, Fukui-shi, Fukui, JAPAN

TEL

0776591300

Homepage URL


Email

yasutaka_k@mri.biglobe.ne.jp


Sponsor or person

Institute

Fukui General Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee of Nittazuka Medical Welfare Center

Address

58-16-1, Egami-cho, Fukui-shi, Fukui, JAPAN

Tel

0776-59-1300

Email

fgh-hisyo@mopera.net


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

2015 Year 04 Month 20 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

2015 Year 04 Month 14 Day

Date of IRB

2015 Year 04 Month 09 Day

Anticipated trial start date

2015 Year 04 Month 20 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 04 Month 14 Day

Last modified on

2019 Year 04 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019876


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name