UMIN-CTR Clinical Trial

Basic information
Public title	Stimulation of peripheral nerves by focused transcranial ultrasound stimulation
Acronym	ultrasound stimulation of peripheral nerve
Scientific Title	Stimulation of peripheral nerves by focused transcranial ultrasound stimulation
Scientific Title:Acronym	ultrasound stimulation of peripheral nerve
Region	Japan

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

Objectives
Narrative objectives1	to establish the method for stimulating the peripheral nerve by focused ultrasound stimulation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	responses evoked by stimulation(conduction velocity, amplitude, distal latency, waveform)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	focus ultrasound stimulation of the peripheral nerve
Interventions/Control_2
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	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	healthy volunteers, age above 20, without neurological deficit or neurological disorder, in whom there is no abnormalitiy in neurological examination
Key exclusion criteria	Subjects under age 20 and those with cognitive impairment or dementia are excluded
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Yasuo Middle name Last name TERao
Organization	Kyorin University
Division name	Faculty of Medicine
Zip code	181-8611
Address	6-20-2 Shinkawa, Mitaka, Tokyo, JPAN
TEL	0422-47-5511
Email	yterao-tky@umin.ac.jp

Public contact
Name of contact person	1st name Yasuo Middle name TERao Last name Terao
Organization	Kyorin University
Division name	Faculty of Medicine
Zip code	181-8611
Address	6-20-2 Shinkawa, Mitaka, Tokyo, JAPAN
TEL	0422-47-5511
Homepage URL
Email	yterao-tky@umin.ac.jp

Sponsor
Institute	Faculty of Medicine, Kyorin University
Institute
Department

Funding Source
Organization	Japan Society for the promotion of Science, Ministry of Education, Science and Culture
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Faculty of Medicine Research Ethics Committee, Kyorin University
Address	6-20-2 Shinkawa, Mitaka, Tokyo, JPAN
Tel	0422-47-5511
Email	irb@ks.kyorin-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	2021 Year 05 Month 11 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	2021 Year 01 Month 01 Day
Date of IRB	2020 Year 05 Month 25 Day
Anticipated trial start date	2021 Year 05 Month 01 Day
Last follow-up date	2025 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 05 Month 09 Day
Last modified on	2021 Year 05 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050414