UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054521 |
|---|---|
| Receipt number | R000062294 |
| Scientific Title | Study of hand stimulation method using repetitive peripheral magnetic stimulation |
| Date of disclosure of the study information | 2024/05/31 |
| Last modified on | 2024/05/30 18:35:18 |
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Basic information
Public title
Study of an efficient method of repetitive peripheral magnetic stimulation of the hand
Acronym
Study of repetitive peripheral magnetic stimulation
Scientific Title
Study of hand stimulation method using repetitive peripheral magnetic stimulation
Scientific Title:Acronym
Study of repetitive peripheral magnetic stimulation
Region
| Japan |
Condition
Condition
cerebrovascular disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarifying the muscle contractions and joint movements that correspond to each position using echo and motion analysis using infrared reflective markers when repetitive peripheral magnetic stimulation (rPMS) was performed at multiple locations on the hand of able-bodied person.
Basic objectives2
Others
Basic objectives -Others
A test conducted to examine changes in specific muscle contractions and joint angles when rPMS is applied to able-bodied adults.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Muscle thickness of lumbrical tendon
Metacarpophalangeal joint angle during stimulation
Key secondary outcomes
Height, weight, hand thickness, hand length, age, gender
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
We used a peripheral magnetic stimulator (Pathleader TM; IFG, Sendai, Japan).
A magnetic stimulation device Pathleader TM (certification number: 227AFBZX00021000) is used for repetitive peripheral magnetic stimulation.
Stimulation frequency: 30Hz
Stimulation intensity: 70-100%MSO (equivalent to maximal stimulator output: 0.65-0.9T)
Stimulation time: 2 seconds
Number of stimulations: 24-30 times in total
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Therapist of our center's rehabilitation department
Key exclusion criteria
Cardiac pacemaker inserter
Those who have magnetic objects that cannot be removed near the stimulation site
Pregnant woman
Those with a history of epilepsy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kagaya |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Rehabilitation
Zip code
474-8511
Address
7-430 Morioka, Obu Aichi, Japan
TEL
0562-46-2311
hkagaya2@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kagaya |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Rehabilitation
Zip code
474-8511
Address
7-430 Morioka, Obu Aichi, Japan
TEL
0562-46-2311
Homepage URL
hkagaya2@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Geriatrics and Gerontology
Address
7-430 Morioka, Obu Aichi, Japan
Tel
0562-46-2311
yaday@ncgg.go.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
| 2024 | Year | 05 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 11 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 23 | 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
| 2024 | Year | 05 | Month | 30 | Day |
Last modified on
| 2024 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062294
