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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027977
Receipt No. 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

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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
Email 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
Email oguro@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Faculty of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032044

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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