UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of magnetic stimulation for reduced hyoid and laryngeal elevation
Title of the study (Brief title)	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	Eiichi Saitoh
Organization	Fujita Health University
Division name	Dept. of Rehabilitation Medicine I, School of Medicine
Address	1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL	0562-93-2167
Email	esaitoh@fujita-hu.ac.jp

Public contact
Name of contact person	Hitoshi Kagaya
Organization	Fujita Health University
Division name	Dept. of Rehabilitation Medicine I, School of Medicine
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 02 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000029964