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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01696812
• Other study ID #: DELAS-201209
• Secondary ID: DELAS
• Status: Not yet recruiting
• Phase: N/A
• First received: September 18, 2012
• Last updated: November 25, 2015
• Start date: November 2014
• Est. completion date: December 2020

Study information

• Verified date: November 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 136
• Est. completion date: December 2020
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Procedure:
• electrode position

Locations

Country	Name	City	State
Korea, Republic of	Department of Neurosurgery, Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	UPDRS, H&Y, ADL scores, LEDD		at 6 and 12 months after surgery	Yes