UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050658 |
|---|---|
| Receipt number | R000057704 |
| Scientific Title | Pain monitoring by electroencephalogram gamma oscillation in the primary somatosensory area |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2024/03/23 09:02:01 |
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Basic information
Public title
Pain monitoring by electroencephalogram gamma oscillation in the primary somatosensory area
Acronym
Pain monitoring by electroencephalogram gamma oscillation in the primary somatosensory area
Scientific Title
Pain monitoring by electroencephalogram gamma oscillation in the primary somatosensory area
Scientific Title:Acronym
Pain monitoring by electroencephalogram gamma oscillation in the primary somatosensory area
Region
| Japan |
Condition
Condition
Not applicable (healthy volunteer study)
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the characteristics of EEG gamma oscillation recorded in the primary somatosensory area upon nociception from healthy volunteers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EEG gamma oscillation in the primary somatosensory area caused by nociception
Key secondary outcomes
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
Diagnosis
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
1: Mechanical noxious stimulus
Device: Pain Vision
Electrically stimulate to the forearms of the subjects
2: Mechanical non-noxious stimulus
Device: von Frey filament
Apply different sizes of filaments on the forearms of the subjects
3: Inflammatory stimulus
Drugs: Allyl isothiocyanate (mustard oil)
Apply allyl isothiocyanate to the forearms of the subjects
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers
Key exclusion criteria
The followings are exclusion criteria;
(1) diseases affecting CNS and chronic pain
(2) chronic use of drugs affecting CNS
(3) overuse of alcohol, use of illicit drugs
(4) diseases on their heads or forearms
(5) inability of understanding, reading, and using Japanese language
(6) allergies of the drugs and devices used in this study
(7) pregnancy, 28 days after delivery, and breast-feeding
(8) anxious about pain
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kotoe |
| Middle name | |
| Last name | Kamata |
Organization
Tohoku University Hospital
Division name
Department of Anesthisiology
Zip code
980-8575
Address
2-1, Seiryomachi, Aobaku, Sendai, Miyagi, 980-8575, Japan
TEL
022-717-7321
mattytohoku@gmail.com
Public contact
Name of contact person
| 1st name | Kotoe |
| Middle name | |
| Last name | Kamata |
Organization
Tohoku University Hospital
Division name
Department of Anesthisiology
Zip code
980-8575
Address
2-1, Seiryomachi, Aobaku, Sendai, Miyagi, 980-8575, Japan
TEL
022-717-7321
Homepage URL
mattytohoku@gmail.com
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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 Tohoku University Graduate School of Medicine
Address
2-1, Seiryomachi, Aobaku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2023 | Year | 04 | 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
22
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2023 | Year | 03 | Month | 23 | Day |
Last modified on
| 2024 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057704
