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

NCT ID: NCT01696812

Last Updated: 2015-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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electrode position, STN DBS, Parkinson' disease

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.

Group Type EXPERIMENTAL

electrode position

Intervention Type PROCEDURE

Interventions

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electrode position

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sun Ha Paek, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Neurosurgery, Seoul National University Hospital

Locations

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Department of Neurosurgery, Seoul National University Hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Facility Contacts

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Sun Ha Paek, M.D., Ph.D.

Role: primary

[email protected]
82-2-2072-3993

Other Identifiers

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DELAS

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

DELAS-201209

Identifier Type: -

Identifier Source: org_study_id