UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046087 |
|---|---|
| Receipt number | 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 | 2022/06/11 10:02:36 |
* 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
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
tomohikoA@med.teikyo-u.ac.jp
Sponsor or person
Institute
Pain Center, Chiba Medical Center, Teikyo University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052598
