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

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ClinicalTrials.gov Identifier: NCT01696812
Recruitment Status : Not yet recruiting
First Posted : October 1, 2012
Last Update Posted : November 30, 2015
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Procedure: electrode position Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. UPDRS, H&Y, ADL scores, LEDD [ Time Frame: at 6 and 12 months after surgery ]


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01696812     History of Changes
Other Study ID Numbers: DELAS-201209
DELAS ( Other Grant/Funding Number: H-1201-074-395 )
First Posted: October 1, 2012    Key Record Dates
Last Update Posted: November 30, 2015
Last Verified: November 2014

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