UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008796 |
|---|---|
| Receipt number | R000010336 |
| Scientific Title | Effect of transcranial direct current stimulation on involuntary movement ofs Cerebral Palsy |
| Date of disclosure of the study information | 2012/09/01 |
| Last modified on | 2015/09/02 19:59:12 |
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Basic information
Public title
Effect of transcranial direct current stimulation on involuntary movement ofs Cerebral Palsy
Acronym
tDCS on CP
Scientific Title
Effect of transcranial direct current stimulation on involuntary movement ofs Cerebral Palsy
Scientific Title:Acronym
tDCS on CP
Region
| Japan |
Condition
Condition
Cerebral Palsy
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure the effect of transcranial direct current stimulation movement and language impairment of cerebral palsy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Movement for arm, neck and mouth.
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
Transcranial direct current stimulation
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
| 6 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cerebral Palsy
Key exclusion criteria
Patients:
1) had previous neurosurgery with implants of metal.
2) had a history head trauma and neurosurgery.
3) had stent placement within the heart.
4) had high pressure heart.
5) are baby.
6) had heart disease.
7) implanted pacemaker.
8) take orally tricyclic antidepressant.
9) had a history of febrile seizures and epilepsy.
10) are a family history of epilepsy.
11) had disease requiring medical care.
12) had sever cognitive impairment.
13) had aphasia.
14) are not suited to this study jugged by PI.
Target sample size
5
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 | Mayumi Nagai |
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
nagai062@gmail.com
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
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
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
| 2012 | Year | 09 | Month | 01 | 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
Completed
Date of protocol fixation
| 2012 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | 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
| 2012 | Year | 08 | Month | 29 | Day |
Last modified on
| 2015 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010336
