UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031138
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email neurosurgery0222@gmail.com

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035571

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.