UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029783 |
|---|---|
| Receipt number | R000034030 |
| Scientific Title | Pain thresholds induced by transcranial magnetic stimulation to the head |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2021/02/17 11:26:15 |
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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
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
tanakas@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034030
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
