UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020030 |
|---|---|
| Receipt number | R000023132 |
| Scientific Title | Assessment of speech and voice disorders in Parkinson's disease patients treated with subthalamic nucleus deep brain stimulation |
| Date of disclosure of the study information | 2015/12/02 |
| Last modified on | 2015/12/24 17:26:32 |
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Basic information
Public title
Assessment of speech and voice disorders in Parkinson's disease patients treated with subthalamic nucleus deep brain stimulation
Acronym
The effect of deep brain stimulation on speech and voice disorders
Scientific Title
Assessment of speech and voice disorders in Parkinson's disease patients treated with subthalamic nucleus deep brain stimulation
Scientific Title:Acronym
The effect of deep brain stimulation on speech and voice disorders
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of speech and voice disorders in Parkinson's disease patients treated with subthalamic nucleus deep brain stimulation
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Assessment of Motor Speech Dysarthria (AMSD)
Patients treated with DBS are assessed at least 6 months after subthalamic implantation. Patients treated without DBS are assessed when they are recruited in this study.
Key secondary outcomes
Stuttering Severity Instrument (SSI-3)
Multi Dimensional Voice Program (MDVP)
Voice Handicap Index (VHI)
GRBAS scale
Maximum phonation time (MPT)
UPDRS
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
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Patients with Parkinson's disease who had undergone bilateral DBS in the Movement Disorders Clinic of the Nagoya University Hospital and had 6-month follow-up period after subthalamic implantation
Interventions/Control_2
Age, sex, disease duration and motor and cognitive function matched PD patients
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed by UK Parkinson's Society Brain Bank Clinical Diagnostic Criteria
Key exclusion criteria
Patients who had Cerebral vascular disorder or any other neurodegenerative diseases
Patients who had severe dementia
Patients who are pregnant
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Gen Sobue |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Neurology
Zip code
Address
65, Tsurumaicho, Showa-ku, Nagoya city, Aichi
TEL
88-52-741-2111
sobueg@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
65, Tsurumaicho, Showa-ku, Nagoya city, Aichi
TEL
88-52-741-2111
Homepage URL
takashi80@gmail.com
Sponsor or person
Institute
Nagoya university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Health and Labour Sciences Research
grants
Organization
Division
Category of Funding Organization
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
| 2015 | Year | 12 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2013 | Year | 02 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | 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
Speech distubance of PD patients who underwent DBS were compared with that of PD patietns who had no experience to undergo DBS.
Management information
Registered date
| 2015 | Year | 12 | Month | 01 | Day |
Last modified on
| 2015 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023132
