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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040316
Receipt No. 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

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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
Email 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
Email shizuko.kosugi@gmail.com

Sponsor
Institute Keio University School of Medicine, Department of Anesthesiology
Institute
Department

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)
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046000

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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