UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of changes in walking ability using transcranial direct current electrical stimulation
Acronym	Analysis of changes in walking ability using transcranial direct current electrical stimulation
Scientific Title	Analysis of changes in walking ability using transcranial direct current electrical stimulation
Scientific Title:Acronym	Analysis of changes in walking ability using transcranial direct current electrical stimulation
Region	Japan

Condition
Condition	healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	analysis of walking ability
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Walking ability
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Factorial
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	stimulation over prefrontal area
Interventions/Control_2	stimulation over motor cortex
Interventions/Control_3	sham stimulation
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	18 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	healthy subjects
Key exclusion criteria	Has a history of peripheral or central neuropathy Has a pacemaker Has metal in the head Pregnant
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Naoyuki Middle name Last name Takeuchi
Organization	Akita University
Division name	Department of Physical Therapy
Zip code	010-8543
Address	1-1-1 Hondo, Akita
TEL	0188846531
Email	n-take@hs.akita-u.ac.jp

Public contact
Name of contact person	1st name Naoyuki Middle name Last name Takeuchi
Organization	Akita University
Division name	Department of Physical Therapy
Zip code	010-8543
Address	1-1-1 Hondo, Akita
TEL	0188846531
Homepage URL
Email	n-take@hs.akita-u.ac.jp

Sponsor
Institute	Akita University, Department of Physical Therapy
Institute
Department

Funding Source
Organization	Japan Society for the promotion of Science
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	Akita University, Department of Physical therapy
Address	1-1-1, Hondo, Akita
Tel	0188846531
Email	n-take@hs.akita-u.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	2022 Year 08 Month 20 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	Open public recruiting
Date of protocol fixation	2022 Year 06 Month 10 Day
Date of IRB	2022 Year 08 Month 10 Day
Anticipated trial start date	2022 Year 08 Month 18 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 08 Month 18 Day
Last modified on	2022 Year 08 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055482