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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000008972
Receipt No. R000010524
Official scientific title of the study Effect of transcranial magnetic stimulation synchronized with actual movement on motor neural plasticity
Date of disclosure of the study information 2012/09/24
Last modified on 2016/10/06

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Basic information
Official scientific title of the study Effect of transcranial magnetic stimulation synchronized with actual movement on motor neural plasticity
Title of the study (Brief title) Effect of transcranial magnetic stimulation synchronized with actual movement on motor neural plasticity
Region
Japan

Condition
Condition stroke patients and healthy subjects
Classification by specialty
Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of transcranial magnetic stimulation synchronized with actual movement on motor neural plasticity
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes finger movement and electroencephalogram
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Real TMS synchronized with actual movement
(Movement times: 120 times, Stimulus intensity: 80 % active motor threshold, Stimulus frequency: 10Hz, Stimulus pulses, 5 pulses per a movement)
Interventions/Control_2 Sham TMS synchronized with actual movement
(Movement times: 120 times, Stimulus intensity: 80 % active motor threshold, Stimulus frequency: 10Hz, Stimulus pulses, 5 pulses per a movement)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 ) enrolled in the study after giving written, informed consent

Healthy subjects after giving written, 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 30

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
Email

Public contact
Name of contact person
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
Homepage URL
Email

Sponsor
Institute Tohoku University Graduate school of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

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
2012 Year 09 Month 24 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2012 Year 09 Month 20 Day
Anticipated trial start date
2012 Year 10 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
2012 Year 09 Month 24 Day
Last modified on
2016 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010524


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