UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044151 |
|---|---|
| Receipt number | R000050414 |
| Scientific Title | Stimulation of peripheral nerves by focused transcranial ultrasound stimulation |
| Date of disclosure of the study information | 2021/05/11 |
| Last modified on | 2021/05/09 17:05:41 |
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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
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
yterao-tky@umin.ac.jp
Sponsor or person
Institute
Faculty of Medicine, Kyorin University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050414
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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