Back to resultsWeb-based International Multi-Center Clinical Study for Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
electrode position
Sponsored by
About this trial
This is an interventional screening trial for Parkinson Disease focused on measuring electrodeposition, Subthalamic Nucleus, Deep Brain Stimulation, Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- Advanced Parkinson Disease patients
Exclusion Criteria:
- The patients who have experienced any perioperative or postoperative complications
- The patients with severe cognitive impairment, ongoing psychiatric problems, an unsatisfactory general condition for evaluation, or an inability
Sites / Locations
- Department of Neurosurgery, Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
electrode position, STN DBS, Parkinson' disease
Arm Description
To determine the electrode positions with the relationship of the STN from the fused images of the preoperative MRI and the postoperative CT via web-site.
Outcomes
Primary Outcome Measures
To determine the electrode positions with the relationship of the STN from the fused images of the preoperative MRI and the postoperative CT
Secondary Outcome Measures
UPDRS, H&Y, ADL scores, LEDD
Full Information
NCT ID
NCT01696812
First Posted
September 18, 2012
Last Updated
November 25, 2015
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01696812
Brief Title
Web-based International Multi-Center Clinical Study for Parkinson's Disease
Official Title
Web-based International Multi-Center Clinical Study for Parkinson's Disease; the Evaluation of Clinical Outcome Based on the Electrode Position Estimated From the Fused Images of Preoperative MRI and Postoperative CT After Bilateral STN DBS
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objectives of this study are (1) to compare the clinical outcome in correlation with the electrode positions estimated by web-based image fusion of the preoperative MRI and the postoperative brain CT taken at a stable period after surgery using mutual information technique in the patients with advanced Parkinson's disease (PD) after bilateral STN DBS and (2) to examine whether the documentation of the electrode position by using mutual information technique at a stable period after unilateral or bilateral STN stimulation provides useful information for the postoperative programming.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
electrodeposition, Subthalamic Nucleus, Deep Brain Stimulation, Parkinson Disease
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
136 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
electrode position, STN DBS, Parkinson' disease
Arm Type
Experimental
Arm Description
To determine the electrode positions with the relationship of the STN from the fused images of the preoperative MRI and the postoperative CT via web-site.
Intervention Type
Procedure
Intervention Name(s)
electrode position
Primary Outcome Measure Information:
Title
To determine the electrode positions with the relationship of the STN from the fused images of the preoperative MRI and the postoperative CT
Time Frame
at 1 month after surgery
Secondary Outcome Measure Information:
Title
UPDRS, H&Y, ADL scores, LEDD
Time Frame
at 6 and 12 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Advanced Parkinson Disease patients
Exclusion Criteria:
The patients who have experienced any perioperative or postoperative complications
The patients with severe cognitive impairment, ongoing psychiatric problems, an unsatisfactory general condition for evaluation, or an inability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun Ha Paek, M.D., Ph.D.
Organizational Affiliation
Department of Neurosurgery, Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurosurgery, Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun Ha Paek, M.D., Ph.D.
Phone
82-2-2072-3993
Email
paeksh@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Sun Ha Paek, M.D., Ph.D.
12. IPD Sharing Statement
Learn more about this trial
Web-based International Multi-Center Clinical Study for Parkinson's Disease
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