UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031138 |
|---|---|
| Receipt number | R000035571 |
| Scientific Title | Feasibility study to evaluate the safety and effectiveness of radiofrequency ablation of the palidothalamic tract for the treatment of Parkinson's disease |
| Date of disclosure of the study information | 2018/02/05 |
| Last modified on | 2018/02/22 09:06:10 |
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Basic information
Public title
Feasibility study to evaluate the safety and effectiveness of radiofrequency ablation of the palidothalamic tract for the treatment of Parkinson's disease
Acronym
Feasibility study of pallidothalamic tractotomy for Parkinson's disease
Scientific Title
Feasibility study to evaluate the safety and effectiveness of radiofrequency ablation of the palidothalamic tract for the treatment of Parkinson's disease
Scientific Title:Acronym
Feasibility study of pallidothalamic tractotomy for Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The proposed study prospective, single arm, single-blind (site rater ) study, is to evaluate the safety and effectiveness of radiofrequency ablation of pallidothalamic tract for Parkinson's disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
UPDRS score
Key secondary outcomes
PDQ-39
SF36
BAI/BDI
AES
FAB
MMSE
Video assessment
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
| Maneuver |
Interventions/Control_1
Radiofrequency ablation
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
Patients with Parkinson's disease who have medically refractory wearing off phenomenon and dyskinesia
Key exclusion criteria
not suitable conditions for surgical intervention
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takaomi Taira |
Organization
Tokyo Women's Medical University
Division name
Department of Neurosurgery
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
ttaira@nij.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shiro Horisawa |
Organization
Tokyo Women's Medical University
Division name
Department of Neurosurgery
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
Homepage URL
neurosurgery0222@gmail.com
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
NA
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
| 2018 | Year | 02 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 05 | 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
| 2018 | Year | 02 | Month | 04 | Day |
Last modified on
| 2018 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035571
