UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015716 |
|---|---|
| Receipt number | R000018271 |
| Scientific Title | Theta burst stimulation for upper limb hemiparesis and motor aphasia after stroke (Transcranial magnetic stimulation) |
| Date of disclosure of the study information | 2014/11/18 |
| Last modified on | 2019/02/17 12:58:25 |
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Basic information
Public title
Theta burst stimulation for upper limb hemiparesis and motor aphasia after stroke (Transcranial magnetic stimulation)
Acronym
Therapeutic approach of TMS for stroke rehabilitation
Scientific Title
Theta burst stimulation for upper limb hemiparesis and motor aphasia after stroke (Transcranial magnetic stimulation)
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Shin-ichi Izumi |
Organization
Tohoku University Graduate school of Biomedical Engineering
Division name
Department of Physical medicine and Rehabilitation
Zip code
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7338
izumis@bme.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Oouchida |
Organization
Tohoku University Graduate school of Medicine
Division name
Department of Physical medicine and Rehabilitation
Zip code
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7338
Homepage URL
oouchida@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate school of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2010 | Year | 07 | Month | 26 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018271
