UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020426 |
|---|---|
| Receipt number | R000023314 |
| Scientific Title | The influence of cold exposure and analysis of abnormalities in ion channels in neuromuscular diseases |
| Date of disclosure of the study information | 2016/01/05 |
| Last modified on | 2023/02/06 09:37:45 |
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Basic information
Public title
The influence of cold exposure and analysis of abnormalities in ion channels in neuromuscular diseases
Acronym
The influence of cold exposure and analysis of abnormalities in ion channels in neuromuscular diseases
Scientific Title
The influence of cold exposure and analysis of abnormalities in ion channels in neuromuscular diseases
Scientific Title:Acronym
The influence of cold exposure and analysis of abnormalities in ion channels in neuromuscular diseases
Region
| Japan |
Condition
Condition
Neuromuscular diseases
Healty subjects
Classification by specialty
| Medicine in general | Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Cold exposure may deteriorate motor paralysis and myotonia in the patients with neuromuscular diseases. Dysfunctions of the ion channels existing in the skeletal muscle cell membrane cause the symptoms such as motor paralysis and myotonia. However, the reasons for the dysfunctions have not been clear in the most of neuromuscular diseases other than primary muscular ion channelopathies. The aim of this study is to examine the influence of cold exposure in subjects with neuromuscular diseases and healthy controls by performing the muscular strength measurement and peripheral nerve conduction studies under the room temperature and the cold exposure.
Basic objectives2
Others
Basic objectives -Others
We prospectively examine the quantitative muscular strength measurement and peripheral nerve conduction studies surrounding cold exposures in subjects with neuromuscular disorders and healthy controls.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Grip power
Key secondary outcomes
Tongue pressure
Peripheral nerve conduction studies
Blood examinations
Brain MRI/MRA
Cervical spine MRI
Pulmonary function test
Dual-energy X-ray Absorption(DXA)
ADL scales
Timed walk test(15 feets)
Rise from bed test
modified quantitative myasthenia gravis score
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patients with neuromusucular disorders
2)Healthy controls
Key exclusion criteria
1)severe complications such as cardiovascular diseases
2)Other severe complications
3)The patients who are judged inappropriate for a participant of this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahisa Katsuno |
Organization
Nagoya University Graduate School of Medicine
Division name
Neurology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2385
ka2no@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Yamada |
Organization
Nagoya University Graduate School of Medicine
Division name
Neurology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2390
Homepage URL
s.yamada@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
JSPS
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 01 | Month | 05 | 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
Main results already published
Date of protocol fixation
| 2015 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This observational study was conducted in compliance with the Declaration of Helsinki, Ethical Guidelines for Human Genome/Gene Analysis Research, and Ethical Guidelines for Medical and Health Research Involving Human Subjects and was approved by the Ethics Review Committee of Nagoya University Graduate School of Medicine.
Management information
Registered date
| 2016 | Year | 01 | Month | 04 | Day |
Last modified on
| 2023 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023314
| 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 |
