UMIN-CTR Clinical Trial

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