UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Measurement of central conduction time in patients with neurological disorders using transcranial magnetic stimulation
Title of the study (Brief title)	Transcranial magnetic stimulation in neurological patients
Region	Japan

Condition
Condition	patients with neurological disorders
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To develop a method to measure central condution time in patients with neurological disorders in the clinical setting
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	central conduction time (central and peripheral latencies of the motor evoked potential), amplitude of the motor evoked potential and how they deviate from normal values depending on the diagnosis
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	Not applicable
Gender	Male and Female
Key inclusion criteria	patients with neurological disorders
Key exclusion criteria	cervical spondylosis, metal inside the body subjects who cannot cooperate, non-adult subjects
Target sample size	20

Research contact person
Name of lead principal investigator	Yasuo Terao
Organization	Faculty of Medicine, Kyorin University
Division name	Department of Cell Physiology
Address	6-20-2 Shinkawa, Mitaka, Tokyo
TEL	+81422475511
Email	yterao-tky@umin.ac.jp

Public contact
Name of contact person	Yasuo Terao
Organization	Faculty of Medicine, Kyorin University
Division name	Department of Cell Physiology
Address	6-20-2 Shinkawa, Mitaka, Tokyo
TEL	+81422475511
Homepage URL
Email	yterao-tky@umin.ac.jp

Sponsor
Institute	Faculty of Medicine, Kyorin University
Institute
Department

Funding Source
Organization	Japan Society for the promotion of Science, Ministry of Education, Science and Culture
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

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	2018 Year 03 Month 10 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 08 Month 03 Day
Anticipated trial start date	2017 Year 10 Month 01 Day
Last follow-up date	2022 Year 08 Month 03 Day
Date of closure to data entry	2022 Year 08 Month 03 Day
Date trial data considered complete	2022 Year 08 Month 03 Day
Date analysis concluded	2027 Year 08 Month 03 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Central motor conduction time measured by transcranial magnetic stimulation

Management information
Registered date	2018 Year 03 Month 05 Day
Last modified on	2019 Year 03 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036065