UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005941 |
|---|---|
| Receipt number | R000007022 |
| Scientific Title | usefulness of neuro mate for stereotactic functional surgery for Parkinson disease |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2015/05/26 11:47:22 |
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Basic information
Public title
usefulness of neuro mate for stereotactic functional surgery for Parkinson disease
Acronym
usefulness of neuro mate for stereotactic functional surgery
Scientific Title
usefulness of neuro mate for stereotactic functional surgery for Parkinson disease
Scientific Title:Acronym
usefulness of neuro mate for stereotactic functional surgery
Region
| Japan |
Condition
Condition
Parkinson disease
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the targetting accuracy and safety of neuro mate assisted deep brain stimulation surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Accuracy of electrode implantation
Unified Parkinson disease rating scale
Key secondary outcomes
Yahr grade, Mini Mental Scale Examination
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
deep brain stimulation
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
Idiopathic Parkinson disease
patients with fluctuated motor symptom and disability of daily life
patients with side effect of drugs
more than 20 years old
not have mental disorder and marked cortical atrophy
informed consent of this clinical study
Key exclusion criteria
patients with severe physical and mental disorder
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasukazu Kajita |
Organization
Nagoya University, Postgraduate School of Medicine
Division name
Neurosurgery
Zip code
Address
65 Tsurumai Syouwa, Nagoya
TEL
052-744-2353
ykajita@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shimizu Shinobu |
Organization
Nagoya University hospital
Division name
center for clinical study and
Zip code
Address
65 Tsurumai Shouwa Nagoya
TEL
052-744-2942
Homepage URL
s-shimizu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya University hospital
Organization
Division
Category of Funding Organization
Self funding
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
| 2011 | Year | 09 | 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
| 2011 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 05 | Month | 14 | Day |
Date analysis concluded
| 2015 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 06 | Day |
Last modified on
| 2015 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007022
