UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of transcranial direct current stimulation (tDCS) on the treatment of neurological diseases
Acronym	Efficacy of transcranial direct current stimulation (tDCS) on the treatment of neurological diseases
Scientific Title	Efficacy of transcranial direct current stimulation (tDCS) on the treatment of neurological diseases
Scientific Title:Acronym	Efficacy of transcranial direct current stimulation (tDCS) on the treatment of neurological diseases
Region	Japan

Condition
Condition	multiple sclerosis, NMOSD, Parkinsonism, brain infarction
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the efficacy of tDCS on the cognitive impairment, motor dysfunction, and dysphagia of neurological diseases
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Assessment of cognitive impairment before and after tDCS treatment
Key secondary outcomes	Assessment of motor dysfunction before and after tDCS treatment

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	ten times tDCS during 2 weeks
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients in our hospital with multiple sclerosis, NMOSD, Parkinsonism, spinocerebellar degeneration, and brain infarction
Key exclusion criteria	Patients with magnetic medical devices such as pace maker and brain aneurysm clip
Target sample size	16

Research contact person
Name of lead principal investigator	1st name Yuji Middle name Last name Nakatsuji
Organization	Toyama University Hospital
Division name	Department of Neurology
Zip code	930-0194
Address	2630 Sugitani, Toyama
TEL	076-434-7309
Email	nakatsuj@med.u-toyama.ac.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Konishi
Organization	Toyama University Hospital
Division name	Department of Neurology
Zip code	930-0194
Address	2630 Sugitani, Toyama
TEL	076-434-7309
Homepage URL
Email	koni16@med.u-toyama.ac.jp

Sponsor
Institute	Toyama University Hospital
Institute
Department

Funding Source
Organization	Ministry of Education
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Toyama University Hospital
Address	2630 Sugitani, Toyama
Tel	076-434-7309
Email	nakatsuj@med.u-toyama.ac.jp

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	2019 Year 07 Month 09 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	Completed
Date of protocol fixation	2018 Year 12 Month 01 Day
Date of IRB	2019 Year 01 Month 07 Day
Anticipated trial start date	2019 Year 03 Month 01 Day
Last follow-up date	2019 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2021 Year 10 Month 18 Day

Other
Other related information

Management information
Registered date	2019 Year 07 Month 09 Day
Last modified on	2022 Year 01 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042544