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Recruitment status Completed
Unique ID issued by UMIN UMIN000008796
Receipt No. R000010336
Official scientific title of the study 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

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Basic information
Official scientific title of the study Effect of transcranial direct current stimulation on involuntary movement ofs Cerebral Palsy
Title of the study (Brief title) 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

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 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

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
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 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 Mayumi Nagai
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 nagai062@gmail.com

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 01 Day

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010336


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