UMIN-CTR Clinical Trial

Basic information
Public title	Pain thresholds induced by transcranial magnetic stimulation to the head
Acronym	Pain thresholds induced by transcranial magnetic stimulation to the head
Scientific Title	Pain thresholds induced by transcranial magnetic stimulation to the head
Scientific Title:Acronym	Pain thresholds induced by transcranial magnetic stimulation to the head
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of the study is to examine pain thresholds induced by transcranial magnetic stimulation to the head.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pain threshold
Key secondary outcomes	perceptual threshold head structural MRI

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Transcranial magnetic stimulation to the head
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Individuals without a neurological or psychiatric history 2. Capability of informed consent based on their own decision
Key exclusion criteria	1. Individuals with a history of head trauma 2. Individuals with a history of organic brain disease 3. Individuals with a history or current history of substance dependence 4. Individuals who are taking central nervous system stimulants 5. Individuals who have a history of disorders of consciousness and/or seizure 6. Individuals who have a chronic headache 7. Individuals who are unable to undergo MRI 8. Individuals who are unable to undergo TMS 9. Individuals that researchers decide that they are inappropriate for study participation.
Target sample size	89

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Tanaka
Organization	Hamamatsu University School of Medicine
Division name	Psychology
Zip code	431-3192
Address	1-20-1 Handayama Higashi-ku, Hamamatsu-city, Japan
TEL	053-453-2111
Email	tanakas@hama-med.ac.jp

Public contact
Name of contact person	1st name Satoshi Middle name Last name Tanaka
Organization	Hamamatsu University School of Medicine
Division name	Psychology
Zip code	431-3192
Address	1-20-1 Handayama Higashi-ku, Hamamatsu-city, Japan
TEL	053-453-2111
Homepage URL
Email	tanakas@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Ministry of Internal Affairs and Communications.
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Hamamatsu University School of Medicine
Address	1-20-1 Handayama Higashi-ku, Hamamatsu-city, Japan
Tel	053-453-2111
Email	tanakas@hama-med.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	浜松医科大学（静岡県） Hamamatsu University School of Medicine (Shizuoka)

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 01 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	2017 Year 10 Month 06 Day
Date of IRB	2017 Year 10 Month 06 Day
Anticipated trial start date	2017 Year 11 Month 01 Day
Last follow-up date	2021 Year 02 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 11 Month 01 Day
Last modified on	2021 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034030