UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028596 |
|---|---|
| Receipt number | 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 | 2020/03/02 11:24:24 |
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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
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
tanaka.yasuhiro@i.mbox.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya university
Institute
Department
Personal name
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
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
No longer recruiting
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
| 2020 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 09 | Day |
Last modified on
| 2020 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032730
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| Registered date | File name |
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