UMIN-CTR Clinical Trial

Basic information
Public title	Effects of repetitive transcranial magnetic stimulation on cortical plasticity
Acronym	Effects of repetitive transcranial magnetic stimulation on cortical plasticity
Scientific Title	Effects of repetitive transcranial magnetic stimulation on cortical plasticity
Scientific Title:Acronym	Effects of repetitive transcranial magnetic stimulation on cortical plasticity
Region	Japan

Condition
Condition	healthy subjects, movement disorders
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of repetitive transcranial magnetic stimulation on cortical plasticity
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Phase I

Assessment
Primary outcomes	Primary outcome measure is cortical plasticity assessed by neurophysiological and behavioural measures up to 3 hours after the intervention.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Real repetitive transcranial magnetic stimulation within 30 min for single session, repeated up to 10 sessions.
Interventions/Control_2	Control repetitive transcranial magnetic stimulation within 30 min for single session, repeated up to 10 sessions.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	healthy control and patients with movement disorders
Key exclusion criteria	The only absolute contraindication to TMS/rTMS is the presence of metallic hardware in close contact to the discharging coil (such as cochlear implants, or an Internal Pulse Generator or medication pumps). In such instances there is a risk of inducing malfunctioning of such implanted devices.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Masashi Middle name Last name Hamada
Organization	the University of Tokyo Hospital
Division name	Neurology
Zip code	1138655
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-5800-8672
Email	mhamada-tky@umin.net

Public contact
Name of contact person	1st name Masashi Middle name Last name Hamada
Organization	the University of Tokyo Hospital
Division name	Neurology
Zip code	1138655
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-5800-8672
Homepage URL
Email	mhamada-tky@umin.net

Sponsor
Institute	Departemtn of Neurology, the University of Tokyo Hospital
Institute
Department

Funding Source
Organization	MEXT(Japan)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethics Committee, Graduate School of Medicine and Faculty of Medicine The University of Tokyo
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
Tel	03-3812-2111(ext.20818)
Email	ethics@m.u-tokyo.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	2015 Year 11 Month 10 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	Completed
Date of protocol fixation	2015 Year 08 Month 01 Day
Date of IRB	2006 Year 06 Month 12 Day
Anticipated trial start date	2015 Year 11 Month 11 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 11 Month 10 Day
Last modified on	2021 Year 05 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022788