UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of peripheral magnetic stimulation for a motor function
Title of the study (Brief title)	The effect of peripheral magnetic stimulation for a motor function
Region	Japan

Condition
Condition	Stroke
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The subject is the patient with the arms or the leg paralysis.We use the repetitive peripheral magnetic stimulation (rPMS) which can stimulate a peripheral nerve and a skeletal muscle noninvasively. After rPMS, we observe the improvement of paralysis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Wolf Motor Fnction Test (WMFT)
Key secondary outcomes	Action Arm Reserch Test (ARAT),10m gait speed,Time Up and Go test

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 peripheral magnetic stimulation for 6 week.
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	79 years-old >=
Gender	Male and Female
Key inclusion criteria	The subject is the patient with the arms or the leg paralysis.
Key exclusion criteria	Pacemaker, Pregnancy, Epilepsy
Target sample size	30

Research contact person
Name of lead principal investigator	Shin-Ichi Izumi
Organization	Tohoku University Graduates School of Medicine
Division name	Department of Physical Medicine and Rehabilitation
Address	2-1 Seiryo-cho, Aoba-ku, Sendai, 980-8575, Japan
TEL	022-717-7338
Email	izumis@med.tohoku.ac.jp

Public contact
Name of contact person	Nao Miyauchi
Organization	Tohoku University Graduates School of Medicine
Division name	Department of Physical Medicine and Rehabilitation
Address	2-1 Seiryo-cho, Aoba-ku, Sendai, 980-8575, Japan
TEL	022-717-7338
Homepage URL
Email	result19870413@yahoo.co.jp

Sponsor
Institute	Tohoku University Graduates School of Medicine
Institute
Department

Funding Source
Organization	Tohoku University Graduates School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 04 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 04 Month 01 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 01 Month 10 Day
Last modified on	2018 Year 01 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035073