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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026088
Receipt No. R000029964
Scientific Title Effect of magnetic stimulation for reduced hyoid and laryngeal elevation
Date of disclosure of the study information 2017/02/10
Last modified on 2018/08/13

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Basic information
Public title Effect of magnetic stimulation for reduced hyoid and laryngeal elevation
Acronym Magnetic stimulation for reduced hyoid and laryngeal elevation
Scientific Title Effect of magnetic stimulation for reduced hyoid and laryngeal elevation
Scientific Title:Acronym Magnetic stimulation for reduced hyoid and laryngeal elevation
Region
Japan

Condition
Condition healthy adult subjects, patients with dysphagia
Classification by specialty
Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of magnetic stimulation for hyoid and laryngeal elevation in healthy adult subjects and patients with dysphagia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Position of hyoid bone and larynx at rest, during magnetic stimulation, and during swallowing reflex.
Key secondary outcomes Pressure of upper esophageal sphincter, muscle force of suprahyoid muscles, muscle fatigue, pain, Dysphagia severity scale, Eating status scale, penetration-aspiration scale

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment
Interventions/Control_1 Magnetic stimulation for suprahyoid muscles is applied within 2 weeks in healthy subjects and over 2 weeks for patients with dysphagia. Intervention is about 10 minutes per day.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) healthy subjects
Gave written informed consent
20 years or older
2) dysphagic patients
In patients in Fujita Health University Hospital
Stable general condition
Reduced hyoid and laryngeal elevation diagnosed by video fluorography or video endoscopy
Gave written informed consent by patient or proxy
20 years or older
Key exclusion criteria 1) healthy subjects
History of stroke, neuromuscular diseases, diseases in larynx and pharynx, respiratory diseases, upper gastrointestinal diseases, epilepsy, pacemaker, magnetic materials around the stimulation area like artificial ear, or impregnated woman
2) dysphagic patients
Unstable condition, unable to follow instructions, epilepsy, pacemaker, magnetic materials around the stimulation area like artificial ear, or impregnated woman
Discharge is expected within 2 weeks
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiichi Saitoh
Organization Fujita Health University
Division name Dept. of Rehabilitation Medicine I, School of Medicine
Zip code
Address 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL 0562-93-2167
Email esaitoh@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitoshi Kagaya
Organization Fujita Health University
Division name Dept. of Rehabilitation Medicine I, School of Medicine
Zip code
Address 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL 0562-93-2167
Homepage URL
Email hkagaya2@fujita-hu.ac.jp

Sponsor
Institute Dept. of Rehabilitation Medicine I, School of Medicine, Fujita Health University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 02 Month 10 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 02 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 02 Month 10 Day
Last modified on
2018 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029964

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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