UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029337 |
|---|---|
| Receipt number | R000033483 |
| Scientific Title | Brain activity during visual presentation of food cues: a functional MRI study of patients with dysphagia |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2021/04/01 17:46:32 |
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Basic information
Public title
Brain activity during visual presentation of food cues: a functional MRI study of patients with dysphagia
Acronym
Brain activity during visual presentation of food cues
Scientific Title
Brain activity during visual presentation of food cues: a functional MRI study of patients with dysphagia
Scientific Title:Acronym
Brain activity during visual presentation of food cues
Region
| Japan |
Condition
Condition
patients with dysphagia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the fMRI study is to examine the brain activity of patients with dysphagia during visual observation of foods with good appearance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
BOLD activity measured by functional MRI during observation of food cues
Key secondary outcomes
Numerical rating scale of appetite
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Visual presentation of food cues (ieat/ blender food)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 patients with dysphagia
2 patients who eat blender foods
Key exclusion criteria
1 patients with metallic medical device in the body
2 patients with severe claustrophobia
3 Pregnant women
4 patients with spatial neglect
5 patients with disturbance of consciousness or higher brain dysfunction who were considered to be inappropriate to participate in the study
6 patients who were considered to be inappropriate to participate in the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Keishi |
| Middle name | |
| Last name | Okamoto |
Organization
Hamamatsu City Rehabilitation Hospital
Division name
Rehabilitation
Zip code
433-8127
Address
Shizuoka Prefecture Hamamatsu City Wagoukita1-6-1
TEL
053-471-8331
k.okamoto@sis.seirei.or.jp
Public contact
Name of contact person
| 1st name | Keishi |
| Middle name | |
| Last name | Okamoto |
Organization
Hamamatsu City Rehabilitation Hospital
Division name
Rehabilitation
Zip code
433-8127
Address
Shizuoka Prefecture Hamamatsu City Wagoukita1-6-1
TEL
053-471-8331
Homepage URL
k.okamoto@sis.seirei.or.jp
Sponsor or person
Institute
Hamamatsu City Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu City Rehabilitation Hospital
Address
Shizuoka Prefecture Hamamatsu City Wagoukita1-6-1
Tel
053-471-8331
k.okamoto@sis.seirei.or.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
浜松市リハビリテーション病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 28 | Day |
Last modified on
| 2021 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033483
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
