UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042222 |
|---|---|
| Receipt number | R000048204 |
| Scientific Title | Multiple neurophysiologic biomarkers evaluated the pulmonary function of ALS. |
| Date of disclosure of the study information | 2020/10/23 |
| Last modified on | 2021/11/05 22:38:44 |
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Basic information
Public title
Multiple neurophysiologic biomarkers evaluated the pulmonary function of ALS.
Acronym
Multiple neurophysiologic biomarkers evaluated the pulmonary function of ALS.
Scientific Title
Multiple neurophysiologic biomarkers evaluated the pulmonary function of ALS.
Scientific Title:Acronym
Multiple neurophysiologic biomarkers evaluated the pulmonary function of ALS.
Region
| Japan |
Condition
Condition
amyotrophic lateral sclerosis(ALS)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For evaluating the pulmonary function of ALS, new neurophysiological evaluations, which performed using phrenic nerve conduction study (PNCS), diaphragm ultrasonography (DUS) and new measurement system of thoracic excursion are proposed as novel biomarkers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
The relationships between neurophysiological biomarkers (amplitude of diaphragmatic compound muscle action potential, diaphragm thickness measured by ultrasonography, thoracic excursion),%FVC of respiratory function test, PaCO2 of blood gas analysis.
Key secondary outcomes
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with definite, or probable and possible ALS based on the modified El Escorial criteria.
Key exclusion criteria
1.Patients who received unapproved drugs in Japan for ALS or underwent surgery within 12 months (48 weeks) before informed consent
2.Patients with dimentia(MMSE<10)
3.Patients with severe phychiatric disorder
4.Patients who are not able to answer questionnaires
5.Patients with suicidal ideation
6.Patients undergoing treatment for respiratory disease
7.Patients with severe heart failure
8.Patients with pregnancy
9.Patients judged to be inappropriate for this study by the investigator or coordinator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Naohiko |
| Middle name | |
| Last name | Iguchi |
Organization
Nara Medical University
Division name
Department of Neurology
Zip code
634-8522
Address
840, Shizyo-cho, Kashihara-City, Nara, Japan
TEL
0744223051
naohiko-iguchi@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Naohiko |
| Middle name | |
| Last name | Iguchi |
Organization
Nara Medical University
Division name
Department of Neurology
Zip code
634-8522
Address
840, Shizyo-cho, Kashihara-City, Nara, Japan
TEL
0744223051
Homepage URL
naohiko-iguchi@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University
Address
840, Shizyo-cho, Kashihara-City, Nara, Japan
Tel
0744223051
naohiko-iguchi@naramed-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
| 2020 | Year | 10 | Month | 23 | 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
| 2020 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 10 | Month | 23 | Day |
Last modified on
| 2021 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048204
