UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Transcranial direct current stimulation (tDCS) therapy for movement disorder and cognitive impairment in neurological patients
Title of the study (Brief title)	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	Hiroaki Oguro
Organization	Shimane University Faculty of Medicine
Division name	Department of Neurology
Address	89-1 Enya cho Izumo city Shimane
TEL	0853202199
Email	oguro@med.shimane-u.ac.jp

Public contact
Name of contact person	Hiroaki Oguro
Organization	Shimane University Faculty of Medicine
Division name	Department of Neurology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	In two multiple system atrophy patients,ataxic scale,ICARS were not changed by tDCS.
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