UMIN-CTR Clinical Trial

Basic information
Public title	Combination approach of transcranial direct current stimulation and functional electorical stimulation for motor training of paretic hand after stroke
Acronym	Transcranial direct current stimulation for paretic hand after stroke
Scientific Title	Combination approach of transcranial direct current stimulation and functional electorical stimulation for motor training of paretic hand after stroke
Scientific Title:Acronym	Transcranial direct current stimulation for paretic hand after stroke
Region	Japan

Condition
Condition	Stroke
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to test the hypothesis that combination of both tDCS and FES would enhance the motor training effects in patients with chronic stroke.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The evaluation is conducted using Wolf Motor Function Test(WMFT). WMFT has 15 functional tasks progressing from simple movements in proximal joints to complex tasks in distal joints using only the affected limb.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	transcranial direct current stimulation(tDCS) and functional electrical stimulation(FES)
Interventions/Control_2	tDCS and FESsham
Interventions/Control_3	tDCSsham and FES
Interventions/Control_4	tDCSsham and FESsham
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Single unilateral ischemic stroke 6 months after stroke onset
Key exclusion criteria	pacemaker metal implants in the brain
Target sample size	13

Research contact person
Name of lead principal investigator	1st name Middle name Last name Naoyuki Takeuchi
Organization	Tohoku University Graduates School of Medicine
Division name	Physical Medicine and Rehabilitation
Zip code
Address	2-1 Seiryo-cho, Aoba-ku, Sendai, 980-8575, Japan
TEL	022-717-7338
Email	naoyuki@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takayuki Mori
Organization	Tohoku University Graduates School of Medicine
Division name	Physical Medicine and Rehabilitation
Zip code
Address	2-1 Seiryo-cho, Aoba-ku, Sendai, 980-8575, Japan
TEL	022-717-7338
Homepage URL
Email	t-mori@med.tohoku.ac.jp

Sponsor
Institute	Department of Physical Medicine and Rehabilitation, Tohoku University Graduates School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2015 Year 04 Month 30 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	Terminated
Date of protocol fixation	2013 Year 10 Month 17 Day
Date of IRB	2013 Year 10 Month 19 Day
Anticipated trial start date	2015 Year 05 Month 11 Day
Last follow-up date	2018 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 05 Month 01 Day
Last modified on	2020 Year 06 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020124