UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046087
Receipt No. R000052598
Scientific Title Analysis of functional changes in the central nervous system in post-COVID-19 syndrome
Date of disclosure of the study information 2021/11/17
Last modified on 2021/11/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Preinitiation
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
2021 Year 11 Month 16 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.