UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026088 |
|---|---|
| Receipt number | 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 09:16:45 |
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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
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
hkagaya2@fujita-hu.ac.jp
Sponsor or person
Institute
Dept. of Rehabilitation Medicine I, School of Medicine, Fujita Health University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029964
