UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Theta burst stimulation for upper limb hemiparesis and motor aphasia after stroke (Transcranial magnetic stimulation)
Title of the study (Brief title)	Therapeutic approach of TMS for stroke rehabilitation
Region	Japan

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

Objectives
Narrative objectives1	To examine the effect of theta burst stimulation on motor and speech disorders after stroke.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Voluntary movement of affected finger Western Aphasia Battery
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	The selected stimulus pattern for motor and speech disorders among 1Hz rTMS, 5Hz rTMS, cTBS, and iTBS, applies for 2 weeks.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient with chronic stroke (more than 3 months from stroke onset) enrolled in the study after giving written and informed consent.
Key exclusion criteria	Metal in cranium, trauma or operation of brain, intracardiac lines, increased intracranial pressure, pregnancy, childhood, heart disease, cardiac pacemaker, medication pump, tricyclic anti-depressants, neuroleptics, febrile convulsion, epilepsy, family history of epilepsy
Target sample size	15

Research contact person
Name of lead principal investigator	Shin-ichi Izumi
Organization	Tohoku University Graduate school of Biomedical Engineering
Division name	Department of Physical medicine and Rehabilitation
Address	2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL	022-717-7338
Email	izumis@bme.tohoku.ac.jp

Public contact
Name of contact person	Yutaka Oouchida
Organization	Tohoku University Graduate school of Medicine
Division name	Department of Physical medicine and Rehabilitation
Address	2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL	022-717-7338
Homepage URL
Email	oouchida@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate school of Medicine
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2014 Year 11 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 07 Month 26 Day
Anticipated trial start date	2010 Year 07 Month 26 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 11 Month 18 Day
Last modified on	2019 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018271