UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062941 |
|---|---|
| Receipt number | R000072062 |
| Scientific Title | Development of head stabilization methods based on the mechanisms of head displacement during brain MRI |
| Date of disclosure of the study information | 2026/09/16 |
| Last modified on | 2026/09/16 05:07:12 |
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Basic information
Public title
A study of head movement during MRI to develop methods for keeping the head still
Acronym
Head movement and stabilization during MRI
Scientific Title
Development of head stabilization methods based on the mechanisms of head displacement during brain MRI
Scientific Title:Acronym
Head displacement and stabilization methods in brain MRI
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To quantitatively characterize head movement during brain MRI and inform the development of head stabilization methods and devices. This preliminary study in one healthy adult will explore head displacement with and without a stabilization device and across device positions and stabilization methods, and assess the feasibility of MRI acquisition and image analysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantitative measures of head movement, including displacement and rotation angles, calculated from cine brain MRI images.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
One healthy adult will undergo repeated cine brain MRI under conditions without a head stabilization device and with the device at different positions and using different stabilization methods. The participant will perform mild head movements in specified directions during each acquisition.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Healthy adults who can undergo brain MRI and understand instructions for mild head movement during imaging.
2. Individuals who provide written informed consent to participate in the study.
Key exclusion criteria
1. Individuals with claustrophobia.
2. Individuals with an active implantable medical device or a similar implanted device.
3. Individuals with a history of head surgery.
4. Individuals who have difficulty maintaining the required position or performing mild head movements during imaging.
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ito |
Organization
Fukushima Medical University
Division name
Department of Radiology and Nuclear Medicine
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima City, Fukushima Japan
TEL
024-547-1334
rad@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Tokiya |
| Middle name | |
| Last name | Yoshii |
Organization
Fukushima Medical University Hospital
Division name
Department of Radiology
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima City, Fukushima Japan
TEL
024-547-1111
Homepage URL
tokiya@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University Ethics Committee
Address
1 Hikarigaoka, Fukushima City, Fukushima, 960-1295, Japan
Tel
024-547-1111
tokiya@fmu.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
| 2026 | Year | 09 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2027 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 16 | Day |
Last modified on
| 2026 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072062
