UMIN-CTR Clinical Trial

Public title

Effectiveness of Lee Silverman Voice Treatment LOUD in Japanese-speaking patients with Parkinson's disease

Acronym

Effectiveness of Lee Silverman Voice Treatment LOUD in Japanese-speaking patients with Parkinson's disease

Scientific Title

Effectiveness of Lee Silverman Voice Treatment LOUD in Japanese-speaking patients with Parkinson's disease

Scientific Title:Acronym

Effectiveness of Lee Silverman Voice Treatment LOUD in Japanese-speaking patients with Parkinson's disease

Region

Japan

Condition

Parkinson's disease

Classification by specialty

Neurology

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Studies on LSVT LOUD have been conducted in a few other languages and have primarily focused on the analysis of acoustic parameters before and after treatment. The increase in conversational intelligibility in both English and Spanish dysarthria in PD patients following LSVT LOUD treatment could be explained by language-universal factors. In addition, LSVT for 4 weeks has been demonstrated to increase vocal loudness and improve intelligibility in Japanese-speaking PD patients: however, the long-term effects of LSVT have not been examined in these patients. Therefore, the present study examined the long-term effects of LSVT in Japanese-speaking PD patients.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The assessments described below were conducted at the following times: 1) pretreatment (Baseline), 2) immediately after four weeks of treatment, and 3) at the end of 12 months of follow-up (12FU) after four weeks of treatment.
1) Vocal loudness
A) Sustained phonation of /a/,B) Reading a passage: "The North Wind and the Sun" C) Delivering a monologue: This task used the Japanese folk tale "Momotaro".

Key secondary outcomes

2) Intelligibility
Intelligibility was assessed based on the reading of a passage and the production of a monologue recorded in vocal loudness testing. The audio samples were arranged randomly and assessed at a constant SPL by three speech-language pathologists with at least five years of experience. The audio data were copied and reassessed to examine the reproducibility of the original assessments. Intelligibility was assessed using a standard Japanese test, as described by Itoh et al. Audio samples were assessed on a nine-level scale in 0.5-point increment, including "1. Completely intelligible," "2. Some unintelligible words," "3. Intelligible if the listener knows the topic," "4. Few intelligible words," and "5. Completely unintelligible." Intraclass correlation coefficients (ICCs) were calculated to determine the assessor with the highest reliability; this assessor's assessments of intelligibility were used as reference values.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

20

years-old

<=

Age-upper limit

85

years-old

>

Gender

Male and Female

Key inclusion criteria

LSVT LOUD training was conducted at our hospital from April 1, 2011 to March 31, 2020

Key exclusion criteria

Person who is diagnosed with dementia

Target sample size

22

Name of lead principal investigator

1st name	KEIGO
Middle name
Last name	NAKAYAMA

Organization

National Center Hospital,National Center of Neurology and Psychiatry

Division name

Department of Rehabilitation Medicine,

Zip code

187-8551

Address

4-1-1 ogawahigashimachi, Kodaira, Tokyo, Japan

TEL

+80-42-341-2711

Email

stnakayama@ncnp.go.jp

Name of contact person

1st name	KEIGO
Middle name
Last name	NAKAYAMA

Organization

National Center Hospital, National Center of Neurology and Psychiatry

Division name

Department of Rehabilitation Medicine

Zip code

187-8551

Address

4-1-1 ogawahigashimachi, Kodaira, Tokyo, Japan

TEL

+80-42-341-2711

Homepage URL

Email

stnakayama@ncnp.go.jp

Institute

National Center Hospital,
National Center of Neurology and Psychiatry

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

IRB, National Center of Neurology and Psychiatry

Address

4-1-1 ogawahigashimachi, Kodaira, Tokyo, Japan

Tel

+80-42-341-2711

Email

rinri-jimu@ncnp.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

03

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

22

Results

Fourteen patients were followed-up until 12FU. Changes in dB SPL from baseline to immediately after treatment were +6.6 dB, +4.2 dB, and 2.8 dB, and those from baseline until 12FU were +4.8 dB, +3.5 dB, and +2.5 dB, respectively.These changes were significant (p < 0.05) in both the baseline-to-post-treatment and baseline-to-12FU intervals.Intelligibility was significantly improved immediately after treatment, but not at 12FU, relative to baseline.

https://doi.org/10.1155/2020/6585264

Results date posted

2019

Year

03

Month

16

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

This study included 21 Japanese PD patients (13 men and 8 women; median age, 68.0 years [range, 64.0 - 70.5 years]; disease duration, 9.0 years [range, 4.0 - 12.5 years]; Modified Unified Parkinson's Disease Rating Scale, 37.0 [range, 24.5 - 52.0]; median MDS-UPDRS Part 2-1(Speech), 1.0 [range, 1.0-2.0]; median MDS-UPDRS Part 3-1(Speech), 1.0 [range, 1.0-2.0]; Hoehn & Yahr Scale stage, 3.0 [range, 2.0 - 3.0]; Raven's Colored Progressive Matrices score, 32.0 [range, 29.5 - 34.0]), and they underwent LSVT at our hospital between April 2011 and February 2018. All patients were clinically diagnosed with possible PD because they met the International Parkinson and Movement Disorder Society clinical diagnosis criteria. In addition, dopamine transporter single-photon emission coupled tomography revealed striatonigral degeneration, and metaiodobenzylguanidine myocardial scintigraphy found a reduced heart-to-mediastinum uptake ratio (delayed images) in all patients.Treatment with antiparkinsonian drugs improved motor symptoms in all patients.

Participant flow

Patients who requested LOUD were intensively trained for 4 weeks and followed up until 12 months.

Adverse events

None

Outcome measures

1) Vocalloudness
2) Intelligibility

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2016

Year

04

Month

01

Day

Date of IRB

2016

Year

06

Month

17

Day

Anticipated trial start date

2016

Year

06

Month

17

Day

Last follow-up date

2020

Year

03

Month

31

Day

Date of closure to data entry

2020

Year

03

Month

31

Day

Date trial data considered complete

2020

Year

03

Month

31

Day

Date analysis concluded

2020

Year

03

Month

31

Day

Other related information

We retrospectively investigated voice volume and intelligibility for patients who received one month of training.
This paper was accepted in October 2019.

Registered date

2019

Year

03

Month

16

Day

Last modified on

2020

Year

12

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041266