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

This study is currently recruiting participants.
Verified October 2012 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01696812
First received: September 18, 2012
Last updated: October 5, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Parkinson Disease
 Procedure: electrode position

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • To determine the electrode positions with the relationship of the STN from the fused images of the preoperative MRI and the postoperative CT [ Time Frame: at 1 month after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • UPDRS, H&Y, ADL scores, LEDD [ Time Frame: at 6 and 12 months after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 136
Study Start Date: September 2012
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Procedure: electrode position

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696812

Locations
Korea, Republic of
Department of Neurosurgery, Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Sun Ha Paek, M.D., Ph.D.     82-2-2072-3993     paeksh@snu.ac.kr    
Principal Investigator: Sun Ha Paek, M.D., Ph.D.            
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Sun Ha Paek, M.D., Ph.D. Department of Neurosurgery, Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01696812     History of Changes
Other Study ID Numbers: DELAS-201209, DELAS
Study First Received: September 18, 2012
Last Updated: October 5, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
electrodeposition
Subthalamic Nucleus
Deep Brain Stimulation
Parkinson Disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 22, 2013