臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 17, 2020
Last modified on	Sept. 22, 2021
Trial ID	jRCTs042200078

Scientific Title	Effects of cerebellar transcranial direct current stimulation on upper limb motor function after stroke: a pilot randomized controlled trial
Public Title	Effects of cerebellar transcranial direct current stimulation on upper limb after stroke

Contact for Scientific Queries	Name	Otaka Yohei
	Affiliation	Fujita Health University
	Address	1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi 470-1192, JAPAN
	Telephone	+81-562-93-2167
	E-mail	rehabmed@fujita-hu.ac.jp
Contact for Public Queries	Name	Yuasa Akiko
	Affiliation	Fujita Health University
	Address	1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi 470-1192, JAPAN
	Telephone	+81-562-93-2167
	E-mail	akiko.yuasa@fujita-hu.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 17, 2020
Actual date of first enrollment
Target sample size		24
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Written informed consent 2. First-ever unilateral supratentorial ischemic or hemorrhagic stroke 3. More than 6 months after the onset 4. Upper-limb hemiplegia (ARAT: Action Research Arm Test >=10, <=51) 5. Independent walking ability (FIM: Functional Independence Measure - Locomotion >=6)
	Exclusion Criteria	1. Unconsciousness or severe aphasia 2. Unable to perform tasks due to severe higher brain dysfunction or psychiatric disorders 3. Cognitive impairment (MMSE: Mini-mental State Examination < 24) 4. Diagnosis of neurological disorders excluding stroke 5. Contraindications to tDCS, TMS, or MRI (i.e., having any metalic implants such as cardiac pacemaker, cardiac pacing leads or surgical clips, history of seizure or epilepsy, severe medical conditions, with pregnancy or during lactation)
	Age Minimum	40age old over
	Age Maximum	80age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Cerebrovascular disease
Intervention(s)		Cerebellar tDCS combined with intensive training of upper limb
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Action research arm test
Secondary Outcome(s)		1. Fugl-Meyer Assessment upper extremity 2. Motor activity log-14 3. Cerebellar brain inhibition 4. Motor evoked potential 5. MRI

Primary Sponsor

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Fujita Health University Certified Review Board
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
Telephone	+81-562-93-2865
E-Mail	crb-f@fujita-hu.ac.jp
Approval Status	Approval
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Sept. 22, 2021	(this page)	Changes
2	April. 02, 2021	Detail	Changes
1	Dec. 17, 2020	Detail

List of change history