UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Before-after study of a transcranial direct current stimulation (tDCS) effects for rehabilitative treatments in subacute brain damaged patients
Title of the study (Brief title)	Effects of a transcranial direct current stimulation (tDCS) in rehabilitative treatments
Region	Japan

Condition
Condition	Cerebrovascular disease, Traumatic brain injury
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effects of a transcranial direct current stimulation on rehabilitative task achievement in subacute brain damaged patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Rehabilitative task achievement: 1) Higher brain disorders; Clinical assessment for attention, Naming task, 2) Motor palsy; Dexterity, Ankle movement, Standing balance, 3) Dysphagia; Swallowing reflex velocity
Key secondary outcomes	Effects on learning skills (Digit span, Tapping span, Repetitive tests of body sways), Safety (Questionnaire surveying for tDCS adverse effects)

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	Transcranial direct current stimulation (2mA intensity for 20 minutes once a day for 5 consecutive days)
Interventions/Control_2	Sham transcranial direct current stimulation (20 minutes once a day for 5 consecutive days)
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients admitted for cerebrovascular disease or traumatic brain injury treatments within 2 months and required rehabilitative treatments to higher brain disorders such as inattention and aphasia, motor palsy, or dysphagia.
Key exclusion criteria	Brain surgery to the tDCS stimulation sites, History of seizure, History of other brain diseases, Epicardial pacemaker implantation
Target sample size	150

Research contact person
Name of lead principal investigator	Kimitaka Hase
Organization	Kansai Medical University Hirakata Hospital
Division name	Department of Rehabilitation Medicine
Address	2-3-1 Shinmachi, Hirakata, Osaka
TEL	072-804-2780
Email	hasekim@hirakata.kmu.ac.jp

Public contact
Name of contact person	Kimitaka Hase
Organization	Kansai Medical University Hirakata Hospital
Division name	Department of Rehabilitation Medicine
Address	hasekim@hirakata.kmu.ac.jp
TEL	072-804-2780
Homepage URL
Email	hasekim@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University Hirakata Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	関西医科大学附属枚方病院（大阪府）

Other administrative information
Date of disclosure of the study information	2013 Year 08 Month 11 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 05 Month 08 Day
Anticipated trial start date	2013 Year 08 Month 12 Day
Last follow-up date	2016 Year 12 Month 25 Day
Date of closure to data entry	2016 Year 12 Month 26 Day
Date trial data considered complete	2016 Year 12 Month 26 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results	http://www7.kmu.ac.jp/rehab/research/
Results
Other related information

Management information
Registered date	2013 Year 08 Month 10 Day
Last modified on	2016 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013396