UMIN-ICDS Clinical Trial

Public title

Cerebrospinal fluid dynamics visualization study using MRI

Acronym

CSFMAP

Scientific Title

CSFMAP

Scientific Title:Acronym

CSFMAP

Region

Japan

North America

Condition

Patients with hydrocephalus, syringomyelia, or arachnoid cysts who are attending or being admitted to facilities participating in this study, including the Department of Neurosurgery, Juntendo University Hospital, and those with normal spinal fluid circulation with headache, unruptured cerebral aneurysm, minor head injury, or minor stroke will be included.

Classification by specialty

Radiology

Neurosurgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Cerebrospinal fluid (CSF) is believed to protect the brain from external forces, but we do not know its detailed fluid dynamics. The purpose of this clinical study is to investigate the causes of hydrocephalus, syringomyelia, and arachnoid cysts, which are believed to be caused by abnormalities in cerebrospinal fluid (CSF), and to select the most appropriate treatment for these diseases. The purpose of this project is to advance in silico analysis of the biological turbulence of CSF that can occur in minor traumatic injuries. We will also analyze the dynamics and physiology of CSF flow as it is altered by external force factors, and examine the causes of traumatic brain injury (TBI).

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

To investigate the causes of these diseases, MRI scans will be performed on patients with normal and those with CSF circulation disorders to collect information on CSF physiology. We will analyze CSF circulation information in each region of the cerebrospinal cord cavity using MRI in patients with normal and in patients with CSF circulation disorders by applying the improved time-slip method sequence to CSF, and develop temporal sequences with up-date.In order to clarify how CSF moves within the ventricles in response to head movement, we attempted to optimize its MRI visualization.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

No need to know

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Perform MRI on normal subjects and patients with spinal fluid circulation disorders to collect and analyze information on cerebrospinal fluid physiology.

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

Age-lower limit

20

years-old

<

Age-upper limit

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Age between 20 and 80 years old at the time of obtaining consent.
(2) After receiving a thorough explanation of the study, the subject of the research has given his/her free and voluntary written consent based on a thorough understanding of the study.

Key exclusion criteria

Those who generally cannot undergo MRI
(1) Patients with claustrophobia
(2) Those who cannot maintain rest in the MRI machine
(3) Those who will have magnetic metals inserted into the body
(iv) Those who have a pacemaker or other device inserted in the body
(5) Other subjects who are deemed inappropriate as research subjects by the principal investigator.

Target sample size

50

Name of lead principal investigator

1st name	MADOKA
Middle name
Last name	NAKAJIMA

Organization

Juntendo University

Division name

Neurosurgery

Zip code

113-8342

Address

2-1-1, hongo, Bunkyo-ku, Tokyo

TEL

0338133111

Email

madoka66@juntendo.ac.jp

Name of contact person

1st name	MADOKA
Middle name
Last name	NAKAJIMA

Organization

Juntendo University

Division name

Neurosurgery

Zip code

113-8342

Address

2-1-1, hongo, Bunkyo-ku, Tokyo

TEL

0338133111

Homepage URL

Email

madoka66@juntendo.ac.jp

Institute

Juntendo University

Institute

Department

Personal name

Organization

National Science Foundation

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization

United States of America

Co-sponsor

Name of secondary funder(s)

Organization

Research Ethics Committee Faculty of Medicine, Juntendo University

Address

3-1-3, Hongo, Bunkyo-ku, Tokyo

Tel

03-5802-1584

Email

hongo-rinri@juntendo.ac.jp

Secondary IDs

YES

Study ID_1

H19-0002

Org. issuing International ID_1

Juntendo University

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

順天堂大学病院付属順天堂医院

Date of disclosure of the study information

2023

Year

11

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2020

Year

03

Month

31

Day

Date of IRB

2020

Year

04

Month

14

Day

Anticipated trial start date

2020

Year

06

Month

01

Day

Last follow-up date

2024

Year

10

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

11

Month

28

Day

Last modified on

2023

Year

11

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060389