UMIN-CTR Clinical Trial

Basic information
Public title	Effective examination of the swallow training that used the cervical interference pattern electrical stimulation for patients with dysphagia
Acronym	Effective examination of the swallow training that used the cervical interference pattern electrical stimulation
Scientific Title	Effective examination of the swallow training that used the cervical interference pattern electrical stimulation for patients with dysphagia
Scientific Title:Acronym	Effective examination of the swallow training that used the cervical interference pattern electrical stimulation
Region	Japan

Condition
Condition	dysphasia
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	For patients with dysphagia (head and neck tumor is postoperative cerebrovascular disorder, neuromuscular disorders), it examine whether there is efficacy of the swallow training that used cervical interference pattern electrical stimulation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The iteration saliva swallow number of times, time before the first occurring for saliva swallow, endoscopy, Videofluorography
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	The group which conducted the swallow training group which used cervical interference pattern electrical stimulation/ only swallw training group
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with dysphagia within three months after the onset that consulted University of Ryukyu otolaryngology after this study approval for a period of ... March, 2019 (head and neck tumor is postoperative cerebrovascular disorder, neuromuscular disorders).
Key exclusion criteria	"2011 for adverse event codialect criteria V4.0 Japanese edition JCOG/LSCO" (an abbreviated designation:) The case with the aspiration symptom of respiratory apparatus grade 3 or more of CTCAE v4.0-JCOG), a chest and mediastinal disorders. (2) It is the case with a wound or the rash to cervical skin. (3) A case to be found of severe cognitive impairment. (4) A case with a pacemaker, the cochlear implant. (5) The case that we cannot report it to whether we felt it for electricity.
Target sample size	9

Research contact person
Name of lead principal investigator	1st name Asanori Middle name Last name Kiyuna
Organization	University of the Ryukyus
Division name	Graduate school of medicine, otolaryngology-head and neck suegery
Zip code	9030215
Address	207 Uehara, Nishihara-cho, Okinawa, Japan
TEL	0988951183
Email	asanori@med.u-ryukyu.ac.jp

Public contact
Name of contact person	1st name Asanori Middle name Last name Kiyuna
Organization	University of the Ryukyus
Division name	Graduate school of medicine, otolaryngology-head and neck suegery
Zip code	9030215
Address	207 Uehara, Nishihara-cho, Okinawa, Japan
TEL	0988951183
Homepage URL
Email	asanori@med.u-ryukyu.ac.jp

Sponsor
Institute	University of the Ryukyus
Institute
Department

Funding Source
Organization	KAKENHI
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	University of the Ryukyus
Address	207 Uehara, Nishihara-cho, Okinawa, Japan
Tel	0988953331
Email	asanori@med.u-ryukyu.ac.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

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 05 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	Completed
Date of protocol fixation	2017 Year 10 Month 12 Day
Date of IRB	2017 Year 09 Month 12 Day
Anticipated trial start date	2017 Year 10 Month 12 Day
Last follow-up date	2020 Year 03 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	2018 Year 06 Month 04 Day
Last modified on	2020 Year 06 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031762