UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of transsranial direct current stimulation in Parkinson's disease
Title of the study (Brief title)	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	Isao Matsushita
Organization	Toyama University Hospital
Division name	Departement of rehabilitation
Address	2630 sugitani toyama city toyama prefecture
TEL	076-434-7850
Email	matusita@med.u-toyama.ac.jp

Public contact
Name of contact person	Koji Ishikuro
Organization	Toyama University Hospital
Division name	Departement of rehabilitation
Address	2630 sugitani toyama city toyama prefecture
TEL	076-434-7850
Homepage URL
Email	ishikuro@med.u-toyama.ac.jp

Sponsor
Institute	Toyama University Hospital
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 12 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037911