NCT01696812

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
136

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 1, 2012

Completed
2.1 years until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 30, 2015

Status Verified

November 1, 2014

Enrollment Period

2.1 years

First QC Date

September 18, 2012

Last Update Submit

November 25, 2015

Conditions

Parkinson Disease

Keywords

electrodepositionSubthalamic NucleusDeep Brain StimulationParkinson Disease

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • UPDRS, H&Y, ADL scores, LEDD

    at 6 and 12 months after surgery

Study Arms (1)

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

electrode positionPROCEDURE
electrode position, STN DBS, Parkinson' disease

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced Parkinson Disease patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery, Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Sun Ha Paek, M.D., Ph.D.

    Department of Neurosurgery, Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2012

First Posted

October 1, 2012

Study Start

November 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2020

Last Updated

November 30, 2015

Record last verified: 2014-11

Locations

KR(1)