UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022646 |
|---|---|
| Receipt number | R000026103 |
| Scientific Title | Pathophysiology of speech and voice disorders in Parkinson's disease patients treated with deep brain stimulation |
| Date of disclosure of the study information | 2016/07/28 |
| Last modified on | 2018/12/11 04:02:59 |
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Basic information
Public title
Pathophysiology of speech and voice disorders in Parkinson's disease patients treated with deep brain stimulation
Acronym
Speech and voice disorders after deep brain stimulation
Scientific Title
Pathophysiology of speech and voice disorders in Parkinson's disease patients treated with deep brain stimulation
Scientific Title:Acronym
Speech and voice disorders after deep brain stimulation
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we analyze speech and voice disorders observed during the contact screening test in detail. We aim to reveal the pathophysiology of speech and voice disorders in Parkinson's disease patients treated with deep brain stimulation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The correlation between speech and voice disorders and the electrode positions
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
One month after deep brain stimulation surgery, we perform the contact-screeing test. The correlation between speech and voice disorders and the electrode positions is analyzed.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Parkinson's disease patients who undergo deep barain stimulation 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
20
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 | Takashi Tsuboi |
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
takashi80@gmail.com
Sponsor or person
Institute
Nagoya university
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
名古屋大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 28 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 07 | Day |
Last modified on
| 2018 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026103
