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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029337
Receipt No. 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 2019/03/14

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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
Email 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
Email k.okamoto@sis.seirei.or.jp

Sponsor
Institute Hamamatsu City Rehabilitation Hospital
Institute
Department

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
Email 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 Enrolling by invitation
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
2019 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033483

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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