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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028596
Receipt No. R000032730
Scientific Title Pathophysiology of speech rhythm disorders in Parkinson's disease patients treated with deep brain stimulation -Comparisons with speech symptoms of other neurological disorders-
Date of disclosure of the study information 2017/08/29
Last modified on 2019/03/25

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Basic information
Public title Pathophysiology of speech rhythm disorders in Parkinson's disease patients treated with deep brain stimulation
-Comparisons with speech symptoms of other neurological disorders-
Acronym Speech rhythm disorders after deep brain stimulation
Scientific Title Pathophysiology of speech rhythm disorders in Parkinson's disease patients treated with deep brain stimulation
-Comparisons with speech symptoms of other neurological disorders-
Scientific Title:Acronym Speech rhythm disorders after deep brain stimulation
Region
Japan

Condition
Condition Parkinson's disease, Cerebellar disease, Upper/lower motor neuron disease
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, we aim to reveal the pathophysiology of speech rhythm disturbance after deep brain stimulation in Parkinson's disease patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Characteristics of speech rhythm disturbance in Parkinson's disease patients differs from the cerebellar, upper/lower motor neuron disorders patients.

Acoustically, we'll use the syllable repetition /pa/.
To assess the speech intelligibility and speech characteristics we use perceptual assessment.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 5
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 In cross-sectional study, we assess the speech of participants. The correlation between characteristics of speech in Parkinson's disease patients and other patients is analyzed.
Interventions/Control_2 Parkinson's disease patients treated only with medical therapy.
Interventions/Control_3 Cerebellar disease patients.
Interventions/Control_4 Patients of upper motor neuron disease.
Interventions/Control_5 Patients of lower motor neuron disease.
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 1. Parkinson's disease patients who undergo deep brain stimulation in Nagoya university hospital.
2. Patients of cerebellar and upper/lower motor neuron disease in Nagoya university hospital.
Key exclusion criteria Patients with further neurological disease, severe cognitive impairment or psychiatric disorders that may hinder the assessment.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahisa Katsuno
Organization Nagoya University Graduate School of Medicine
Division name Department of Neurology
Zip code
Address Showa-ku, Nagoya 466-8550, Japan
TEL 052-744-2391
Email ka2no@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhiro Tanaka
Organization Nagoya University Graduate School of Medicine
Division name Department of Neurology
Zip code
Address Showa-ku, Nagoya 466-8550, Japan
TEL 052-744-2391
Homepage URL
Email tanaka.yasuhiro@i.mbox.nagoya-u.ac.jp

Sponsor
Institute Nagoya university
Institute
Department

Funding Source
Organization Nagoya University
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
Address
Tel
Email

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
2017 Year 08 Month 29 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 Enrolling by invitation
Date of protocol fixation
2017 Year 08 Month 01 Day
Date of IRB
2017 Year 11 Month 15 Day
Anticipated trial start date
2017 Year 11 Month 15 Day
Last follow-up date
2020 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 03 Month 15 Day

Other
Other related information

Management information
Registered date
2017 Year 08 Month 09 Day
Last modified on
2019 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032730

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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