UMIN-CTR Clinical Trial

Basic information
Public title	Effects of transcranial electrical stimulation over the posterior parietal cortex on motor function and brain activity.
Acronym	Effects of transcranial electrical stimulation over the posterior parietal cortex on motor function and brain activity.
Scientific Title	Effects of transcranial electrical stimulation over the posterior parietal cortex on motor function and brain activity.
Scientific Title:Acronym	Effects of transcranial electrical stimulation over the posterior parietal cortex on motor function and brain activity.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to clarify the effects of transcranial electrical stimulation over the posterior parietal cortex and the changes in brain activity.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Motor evoked potential, visuomotor control task, joint position matching task, simon task, flanker task
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are 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	Conditions that apply transcranial electrical stimulation over the posterior parietal cortex for 15 minutes.
Interventions/Control_2	Conditions that apply sham transcranial electrical stimulation over the posterior parietal cortex for 30 seconds.
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	18 years-old <=
Age-upper limit	27 years-old >=
Gender	Male and Female
Key inclusion criteria	Persons who have been interested in this experiment and who voluntarily wished to participate in this experiment.
Key exclusion criteria	Exclusion criteria are pregnant women, patients on dialysis, taking neuro-active drugs, having metal or electronic devices in body, previous epileptic seizures, nerve damage, skin disease at the location of electrode application, and previous orthopedic disease in the ankle.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yasushi Middle name Last name Kamii
Organization	Graduate School, Niigata University of Health and Welfare
Division name	Institute for Human Movement and Medical Sciences
Zip code	950-3198
Address	1398 Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan
TEL	025-257-4445
Email	hpm21004@nuhw.ac.jp

Public contact
Name of contact person	1st name Yasushi Middle name Last name Kamii
Organization	Graduate School, Niigata University of Health and Welfare
Division name	Institute for Human Movement and Medical Sciences
Zip code	950-3198
Address	1398 Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan
TEL	025-257-4445
Homepage URL
Email	hpm21004@nuhw.ac.jp

Sponsor
Institute	Niigata University of Health and Welfare
Institute
Department

Funding Source
Organization	Niigata University of Health and Welfare
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	Ethics Committee, Niigata University of Health and Welfare
Address	1398 Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan
Tel	025-257-4455
Email	rinri@nuhw.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 18 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	Preinitiation
Date of protocol fixation	2022 Year 07 Month 14 Day
Date of IRB
Anticipated trial start date	2022 Year 08 Month 19 Day
Last follow-up date	2024 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=R000055486