UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033253 |
|---|---|
| Receipt number | R000037911 |
| Scientific Title | Efficacy and safety of transsranial direct current stimulation in Parkinson's disease |
| Date of disclosure of the study information | 2018/07/03 |
| Last modified on | 2018/07/03 09:11:29 |
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Basic information
Public title
Efficacy and safety of transsranial direct current stimulation in Parkinson's disease
Acronym
Whether tDCS can improve the symptoms of Parkinson's disease?
Scientific Title
Efficacy and safety of transsranial direct current stimulation in Parkinson's disease
Scientific Title:Acronym
Whether tDCS can improve the symptoms of Parkinson's disease?
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Whether tDCS can improve the symptoms of Parkinson's disease?
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
UPDRS(unified parkinson's disease rating scale)
Key secondary outcomes
STEF(simple test for evaluating hand function), FMA(fugl-meyer assessment), MMSE(mini mental state examination), TMT(trail maiking test)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are 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
Transcranial direct current stimulation(Anodal )
Interventions/Control_2
Transcranial direct current stimulation(Sham)
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Parkinson's disease(include doubt)
Key exclusion criteria
The subject with the Metal in the body
pregnant
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Isao Matsushita |
Organization
Toyama University Hospital
Division name
Departement of rehabilitation
Zip code
Address
2630 sugitani toyama city toyama prefecture
TEL
076-434-7850
matusita@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Ishikuro |
Organization
Toyama University Hospital
Division name
Departement of rehabilitation
Zip code
Address
2630 sugitani toyama city toyama prefecture
TEL
076-434-7850
Homepage URL
ishikuro@med.u-toyama.ac.jp
Sponsor or person
Institute
Toyama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Toyama University Hospital
Organization
Division
Category of Funding Organization
Other
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
| 2018 | Year | 07 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 12 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 03 | 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
| 2018 | Year | 07 | Month | 03 | Day |
Last modified on
| 2018 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037911
