UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053666 |
|---|---|
| Receipt number | R000061236 |
| Scientific Title | Research on the advancement of tremor suppression devices and tremor evaluation systems using magnetic materials |
| Date of disclosure of the study information | 2024/02/22 |
| Last modified on | 2024/02/21 05:43:39 |
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Basic information
Public title
Research on the advancement of tremor suppression devices and tremor evaluation systems using magnetic materials
Acronym
Research on the advancement of tremor suppression devices and tremor evaluation systems using magnetic materials
Scientific Title
Research on the advancement of tremor suppression devices and tremor evaluation systems using magnetic materials
Scientific Title:Acronym
Research on the advancement of tremor suppression devices and tremor evaluation systems using magnetic materials
Region
| Japan |
Condition
Condition
Those who have tremor caused by neurodegenerative disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effectiveness of the developed tremor suppression device and the tremor evaluation system were evaluated by conducting clinical evaluations with tremor patients on the tremor suppression device and tremor evaluation system using magnetic materials, which were researched and developed by the Miyazaki Prefectural Industrial Technology Center.The purpose is to contribute to the advancement of evaluation systems. Furthermore, the tremor suppression device in this study is not intended as a fundamental treatment for tremor, but as a measure to improve ADL and QOL.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of target figures and drawn figures using image processing with and without restraint braces (on the day of measurement)
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
The intervention is performed only on the day of measurement (the intervention period is 1 day and the number of interventions is 1 time), and the drawing test is conducted with and without the equipment.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients whose native language is Japanese
Patients who are 20 years of age or older at the time of obtaining consent
Patients whose dominant hand tremor is considered to be interfering with daily life
Patients who have received sufficient explanation and informed written consent of their own free will to participate in this study.
Key exclusion criteria
Patients with involuntary movements other than tremor
Patients who are adversely affected by magnetism
Other subjects judged by the implementation director to be inappropriate as research subjects
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Kobayashi |
Organization
University of Miyazaki Hospital
Division name
Department of Rehabilitation
Zip code
889-1692
Address
5200 Kihara, Kiyotake-cho, Miyazaki-shi, Miyazaki Prefecture
TEL
0985851510
tomoyuki_kobayashi@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Kobayashi |
Organization
University of Miyazaki Hospital
Division name
Department of Rehabilitation
Zip code
889-1692
Address
5200 Kihara, Kiyotake-cho, Miyazaki-shi, Miyazaki Prefecture
TEL
0985851510
Homepage URL
tomoyuki_kobayashi@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Others
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Miyazaki Hospital
Address
5200 Kihara, Kiyotake-cho, Miyazaki-shi, Miyazaki Prefecture
Tel
0985851510
tomoyuki_kobayashi@med.miyazaki-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
| 2024 | Year | 02 | Month | 22 | 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
| 2022 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 16 | 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 | 02 | Month | 21 | Day |
Last modified on
| 2024 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061236
| 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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| Registered date | File name |
