Web-based International Multi-Center Clinical Study for P... | NCT01696812

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

NCT01696812

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Nov 30, 2015Estimated

Enrollment

136Estimated

Phase

Not Applicable

Conditions

Parkinson Disease

Interventions

electrode position

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
DELAS	Other Grant/Funding Number	H-1201-074-395

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Sep 18, 2012

First Submission Date that Met QC Criteria

Sep 28, 2012

First Posted Date

Oct 1, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2015

Last Update Posted Date

Nov 30, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

136Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
electrode position, STN DBS, Parkinson' disease	Experimental	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.	Procedure: electrode position

Interventions

Name	Type	Description	Arm Group Labels	Other Names
electrode position	Procedure		electrode position, STN DBS, Parkinson' disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
UPDRS, H&Y, ADL scores, LEDD		at 6 and 12 months after surgery

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sun Ha Paek, M.D., Ph.D.	Department of Neurosurgery, Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurosurgery, Seoul National University Hospital		Seoul	Seoul	110-744	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided