UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of functional changes in the central nervous system in post-COVID-19 syndrome
Acronym	Analysis of functional changes in the central nervous system in post-COVID-19 syndrome
Scientific Title	Analysis of functional changes in the central nervous system in post-COVID-19 syndrome
Scientific Title:Acronym	Analysis of functional changes in the central nervous system in post-COVID-19 syndrome
Region	Japan

Condition
Condition	Post-COVID-19 syndrome
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Neural connections in the brain of patients with post-COVID-19 syndrome will be analyzed by resting state functional MRI to examine their association with clinical symptoms.
Basic objectives2	Others
Basic objectives -Others	We will compare changes in the neural functional connections among post-COVID-19 syndrome, chronic fatigue syndrome, and fibromyalgia patients.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	We analyze the time-series changes in the BOLD signal between any two regions for whole brain (voxel, ROI, network) in post-COVID-19 syndrome patients, and search for regions with different functional connectivity from healthy subjects.
Key secondary outcomes	We will compare the functional connectivity of the central nervous system for post-COVID-19 syndrome, chronic fatigue syndrome, and fibromyalgia patients.

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	70 years-old >
Gender	Male and Female
Key inclusion criteria	post-COVID-19 syndrome patients Patients with fibromyalgia Patients with chronic fatigue syndrome Healthy subjects
Key exclusion criteria	SARS-CoV-2 persistent infection Complications of severe mental illness such as schizophrenia Alcohol or drug addiction left handed During pregnancy or lactation, Under 20 years old, over 70 years old Physical or psychological situations inappropriate for MRI imaging Morphological abnormal findings of the brain revealed by simple brain MRI
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Tomohiko Middle name Last name Aoe
Organization	Teikyo University
Division name	Pain Center, Chiba Medical Center
Zip code	299-0111
Address	3426-3 Anesaki, Ichihara City, Chiba 299-0111, Japan
TEL	0436-62-1211
Email	tomohikoA@med.teikyo-u.ac.jp

Public contact
Name of contact person	1st name Tomohiko Middle name Last name Aoe
Organization	Teikyo University
Division name	Pain Center, Chiba Medical Center
Zip code	299-0111
Address	3426-3 Anesaki, Ichihara City, Chiba 299-0111, Japan
TEL	0436-62-1211
Homepage URL
Email	tomohikoA@med.teikyo-u.ac.jp

Sponsor
Institute	Pain Center, Chiba Medical Center, Teikyo University
Institute
Department

Funding Source
Organization	Teikyo University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Teikyo University Ethical Review Board for Medical and Health Research Involving Human Subjects
Address	2-11-1 Kaga, Itabashi-Ku, Tokyo
Tel	03-3964-7256
Email	turb-office@teikyo-u.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	ちば総合医療センター

Other administrative information
Date of disclosure of the study information	2021 Year 11 Month 17 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	2021 Year 11 Month 05 Day
Date of IRB	2021 Year 11 Month 05 Day
Anticipated trial start date	2021 Year 11 Month 17 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Neural connections in the brain of patients with post-COVID-19 syndrome will be analyzed by resting state functional MRI to examine their association with clinical symptoms.

Management information
Registered date	2021 Year 11 Month 16 Day
Last modified on	2022 Year 06 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052598