UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of transcranial direct current stimulation for dysphonia
Acronym	Transcranial direct current stmulation for dysphonia
Scientific Title	Effectiveness of transcranial direct current stimulation for dysphonia
Scientific Title:Acronym	Transcranial direct current stmulation for dysphonia
Region	Japan

Condition
Condition	Spasmodic dysphonia, essential voice tremor, psychogenic aphonia
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether there is utility of tDCS for dysphonia that currently has no effective treatment.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	laryngeal fiberscope findings, perceptual assessment, aerodynamic measures, acoustic analysis, hindrance degree evaluation, voice handicap index, adverse event
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	dysphonina group(a part of spasmodic dysphonia, essential voice tremor, psychogenic sphonia):Electric brain stimulation is performed once and evaluated 2 weeks later. One stimulation is 1-2 mA in 5-20 minutes. After 2 weeks, stimulate by changing areas and tasks. a) stimulation while phonation, b) stimulation without phonation, c) not actually stimulating without informing the subject(sham stimulation) (phonation), and evaluating the improvement degree of the phonation. With respect to the phonation task, a voice therapy (rehabilitation) by a speech therapist is performed while electric stimulation is performed. The stimulation areas are primary motion area, cerebellum, parietal lobe in Spasmodic dysphonia, primary motor cortex, cerebellum in essential voice tremor, primary motor cortex, frontal lobe in psychogenic aphonia. Evaluated two weeks after stimulation once. Then change stimulation task, stimulation areas.
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with dysphonia: 1.Patients who have visited our hospital during the period 2. In spasmodic dysphonia, there is no indication or hope for surgical treatment, or the patient has operated but the symptoms remain 3. voice rehabilitation was performed for 3 months or more but there was no effect
Key exclusion criteria	Patients with dysphonia:1.cases with brain abnormalities such as epilepsy, cerebral infarction, brain tumor 2. Case in which there are scars, eczema, etc in the head skin 3. Cases with poor physical condition on the day of examination
Target sample size	5

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	igzknkyusen@to.jim.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 03 Month 15 Day
Date of IRB	2017 Year 03 Month 01 Day
Anticipated trial start date	2017 Year 03 Month 15 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=R000029877