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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name