UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040316 |
|---|---|
| Receipt number | R000046000 |
| Scientific Title | An fMRI study showing the association between after sensation and brain function |
| Date of disclosure of the study information | 2020/05/07 |
| Last modified on | 2020/05/07 09:01:12 |
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Basic information
Public title
Functional MRI study for the association between after sensation and brain functional connectivity network
Acronym
Study for after sensation and brain functional connectivity network
Scientific Title
An fMRI study showing the association between after sensation and brain function
Scientific Title:Acronym
An fMRI study showing the association between after sensation and brain function
Region
| Japan |
Condition
Condition
Chronic pain in the orofacial area
Classification by specialty
| Anesthesiology | Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate using functional MRI that the duration of after sensation by thermal stimulation is associated with brain activity and functional connectivity.
Basic objectives2
Others
Basic objectives -Others
To evaluate the hypothesis that the duration of after sensation induced by repetitive thermal stimulation is associated with activity in specific brain regions and strength of brain function connectivity.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between pain VAS and persistence of after sensation and strength of functional connectivity of brain regions (ACC, IC, PFC, PCC, PAG, thalamus, hypothalamus) in patient groups
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Chronic pain patient group: 1) Right-handed, 2) having chronic orofacial pain for 3 months or more, 3) pain of 4 or more on the Numerical Rating Scale (NRS; scale of 0-10) at the initial visit.
Healthy group: 1)Right-handed, 2)age- and sex- matched, 3)not receiving treatment for pain over the past 1 month and more.
Key exclusion criteria
Organic brain disease patients
MRI Contraindications.
Patients who cannot maintain immobility during MRI.
Pregnant women or patients who may be pregnant (will).
Healthy group only:
Mental disorders (depression, epilepsy, schizophrenia, Alzheimer's disease, etc.)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shizuko |
| Middle name | |
| Last name | Kosugi |
Organization
Keio University School of Medicine
Division name
Department of Anesthesiology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3810
shizuko.kosugi@gmail.com
Public contact
Name of contact person
| 1st name | Shizuko |
| Middle name | |
| Last name | Kosugi |
Organization
Keio University School of Medicine
Division name
Department of Anesthesiology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3810
Homepage URL
shizuko.kosugi@gmail.com
Sponsor or person
Institute
Keio University School of Medicine, Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine, Department of Anesthesiology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kawasaki Municipal Ida Hospital, Department of Dentistry and Oral surgery.
Keio University School of Medicine,
Department of Dentistry and Oral surgery.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211 (62014)
med-rinri-jimu@adst.keio.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
| 2020 | Year | 05 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
From May 7, 2019 to December 31, 2023, the chronic pain patient group is selected from patients who satisfied selection criteria in the Department of Dentistry and Oral Surgery at Keio University Hospital or Kawasaki Municipal Ida Hospital for the treatment of chronic pain in the orofacial area.
The healthy group requests research cooperation through a staffing agency.
The subject answers the questionnaire and receives MRI under thermal stimulation on the upper arm.
Management information
Registered date
| 2020 | Year | 05 | Month | 07 | Day |
Last modified on
| 2020 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046000
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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