UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032863
Receipt number 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 14:10:26

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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 or person

Institute

University of the Ryukyus

Institute

Department

Personal name



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

Value
https://center6.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