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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032863
Receipt No. R000029877
Scientific Title Effectiveness of transcranial direct current stimulation for dysphonia
Date of disclosure of the study information 2018/06/05
Last modified on 2020/06/08

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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/ctr_e/ctr_view.cgi?recptno=R000029877

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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