UMIN-CTR Clinical Trial

Basic information
Public title	Search for quantitative physiological indicators as biomarkers that reflect movement disorders in patients with neuromuscular disease
Acronym	Search for quantitative physiological indicators in patients with neuromuscular disease
Scientific Title	Search for quantitative physiological indicators in patients with neuromuscular disease
Scientific Title:Acronym	Search for quantitative physiological indicators as biomarkers that reflect movement disorders in patients with neuromuscular disease
Region	Japan

Condition
Condition	neuromuscular disease
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	If it becomes possible to quantify the degree of movement disorders in patients with neuromuscular diseases by physiological tests, it will be possible to more objectively determine the effects of treatment including medication. Therefore, we will search for physiological tests that correlate with movement disorders.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	The Primary endpoint is the identification of physiological tests that correlate with movement disorders.
Key secondary outcomes	The Secondary endpoint is a secondary analysis of whether the combination provides a more accurate index when there are multiple correlated physiological tests.

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) To exclude patients with internal disorders other than neuromuscular diseases 2) Considering the correlation between the motor function evaluation scale and the severity of the disease, if it is difficult to maintain a standing position, the floor effect of the scale reduces the correlation with the severity. 3) To obtain the validity of the test results
Key exclusion criteria	1) Patients who cannot get a definitive diagnosis after starting treatment at our hospital 2) Dementia patients 3) Others who are judged to be inappropriate by the principal investigator
Target sample size	100

Research contact person
Name of lead principal investigator	1st name hashide Middle name Last name shusei
Organization	national center of neurology and psychiatry
Division name	rehabilitation medicine
Zip code	187-8551
Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo, Japan
TEL	042-341-2711
Email	s-hashide@ncnp.go.jp

Public contact
Name of contact person	1st name hashide Middle name Last name shusei
Organization	national center of neurology and psychiatry
Division name	rehabilitation medicine
Zip code	187-8551
Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo, Japan
TEL	042-341-2711
Homepage URL
Email	s-hashide@ncnp.go.jp

Sponsor
Institute	national center of neurology and psychiatry
Institute
Department

Funding Source
Organization	national center of neurology and psychiatry
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical Trial Review Committee
Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo, Japan
Tel	0423412711
Email	rinri@ncnp.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	2021 Year 04 Month 24 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	Open public recruiting
Date of protocol fixation	2020 Year 08 Month 27 Day
Date of IRB	2020 Year 08 Month 27 Day
Anticipated trial start date	2020 Year 08 Month 27 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We are accumulating test data for neuromuscular diseases at any time.

Management information
Registered date	2021 Year 04 Month 24 Day
Last modified on	2021 Year 07 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050276