UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027977 |
|---|---|
| Receipt number | R000032044 |
| Scientific Title | Transcranial direct current stimulation (tDCS) therapy for movement disorder and cognitive impairment in neurological patients |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2018/04/27 19:16:37 |
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Basic information
Public title
Transcranial direct current stimulation (tDCS) therapy for movement disorder and cognitive impairment in neurological patients
Acronym
tDCS study
Scientific Title
Transcranial direct current stimulation (tDCS) therapy for movement disorder and cognitive impairment in neurological patients
Scientific Title:Acronym
tDCS study
Region
| Japan |
Condition
Condition
post stroke, parkinson's disease, multiple system atrophy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of tDCS(transcranial direct current stimulation) therapy for movement disorder and cognitive impairment in neurological patients(post stroke, parkinson's disease, multiple system atrophy).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motor function are Unified Parkinoson's Disease Rating Scale(UPDRS) and International Cooperative Ataxia Rating Scale (ICARS).
Memory function are MMSE and HDSR. Frontal function is Frontal Assessment Battery,FAB.Mood scale are Apathy scale and Self depression scale, SDS.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
The tDCS stimulation menus are 2mA intensity with 20 minutes a day for 5 days.
Interventions/Control_2
The sham stimulation is setted in tDCS program.
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
post stroke
parkinson's disease
multiple system atrophy
Key exclusion criteria
Psychiatric disorder(major depression,schizophrenia),drug abuse,epilepsy,post head injury
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Oguro |
Organization
Shimane University Faculty of Medicine
Division name
Department of Neurology
Zip code
Address
89-1 Enya cho Izumo city Shimane
TEL
0853202199
oguro@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Oguro |
Organization
Shimane University Faculty of Medicine
Division name
Department of Neurology
Zip code
Address
89-1 Enya cho Izumo city Shimane
TEL
0853202199
Homepage URL
oguro@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shimane University Faculty of Medicine
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
| 2017 | Year | 08 | 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
In two multiple system atrophy patients,ataxic scale,ICARS were not changed by tDCS.
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
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 05 | Month | 31 | Day |
Other
Other related information
Research ended because of difficulty in enrolling patients.
Management information
Registered date
| 2017 | Year | 06 | Month | 28 | Day |
Last modified on
| 2018 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032044
