UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025078 |
|---|---|
| Receipt number | R000028844 |
| Scientific Title | High frequency subthalamic stimulation for dyskimesia of Parkinson's disease |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2021/12/20 10:02:26 |
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Basic information
Public title
High frequency subthalamic stimulation for dyskimesia of Parkinson's disease
Acronym
High frequency subthalamic stimulation for dyskimesia of Parkinson's disease
Scientific Title
High frequency subthalamic stimulation for dyskimesia of Parkinson's disease
Scientific Title:Acronym
High frequency subthalamic stimulation for dyskimesia of Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the performance for dyskinesia of high frequency DBS compared to conventional DBS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AIMS
Key secondary outcomes
UPDRS-Part3, 4
BFMDRS
CGIS/PGIS
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
high frequency subthalamic stimulation
Interventions/Control_2
conventional subthalamic stimulation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Implanted bilaterally in STN with a DBS system(Activa SC/RC) for Parkinson's disease for at least six months and programming optimized according to standard of care.
Diagnosis of bilateral idiopathic PD with the presence of dyskinesia.
Key exclusion criteria
Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator.
Any current drug or alcohol abuse as determined by the investigator.
Any history of recurrent or unprovoked seizures.
Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival less than 12 months.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Genko Oyama |
Organization
Juntendo University Hospital
Division name
Department of Neurology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
g_oyama@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fuyuko Sasaki |
Organization
Juntendo University Hospital
Division name
Department of Neurology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
fsasaki@juntendo.ac.jp
Sponsor or person
Institute
Department of Neurology, Juntendo University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Neurology, Juntendo University Hospital
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
| 2016 | Year | 12 | Month | 01 | 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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 30 | Day |
Last modified on
| 2021 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028844
