Web-based International Multi-Center Clinical Study for Parkinson's Disease

Not Applicable

• Conditions: Parkinson Disease
• Interventions: Procedure: electrode position

• Registration Number: NCT01696812
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2012-09-18
• Study First Submitted QC: 2012-09-28
• Study First Posted: 2012-10-01
• Status Verified: 2014-11
• Study Start: 2014-11
• Last Update Submitted: 2015-11-25
• Last Update Posted: 2015-11-30
• Primary Completion: 2016-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• Advanced Parkinson Disease patients

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
electrode position, STN DBS, Parkinson' disease	electrode position	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.

Primary Outcome Measures

Name	Time	Method
To determine the electrode positions with the relationship of the STN from the fused images of the preoperative MRI and the postoperative CT	at 1 month after surgery

Secondary Outcome Measures

Name	Time	Method
UPDRS, H&Y, ADL scores, LEDD	at 6 and 12 months after surgery

Trial Locations

Locations (1)

Department of Neurosurgery, Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of