Follow Up Study for Treatment of Parkinson's Disease With Subthalamic Deep Brain Stimulation
Long Term Study of Subthalamic Deep Brain Stimulation for Parkinson's Disease
1 other identifier
observational
20
1 country
1
Brief Summary
This study aims to evaluate the long term effect of deep brain stimulation in the the subthalamic nucleus (STN) in patients with Parkinson's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2017
CompletedStudy Start
First participant enrolled
July 24, 2017
CompletedFirst Posted
Study publicly available on registry
July 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedMarch 11, 2020
March 1, 2020
1.8 years
July 24, 2017
March 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Changs in the score of Stand-Walk-Sit Test
above 10 years post surgery
Secondary Outcomes (13)
Change of the score in United Parkinson Disease Rating Scale (UPDRS) part III
above 10 years post surgery
UPDRS part I score
above 10 years post surgery
UPDRS part II score
above 10 years post surgery
UPDRS part IV score
above 10 years post surgery
39-Item Parkinson´s Disease Questionnaire (PDQ-39) score
above 10 years post surgery
- +8 more secondary outcomes
Study Arms (2)
STN DBS
Parkinson's disease (PD) patients who underwent deep brain stimulation (DBS) of the subthalamic nucleus (STN)
CONTROL
Parkinson's disease (PD) patients received optimized medical treatment according to published evidence based guidelines
Eligibility Criteria
Patients with Parkinson's Disease who underwent STN DBS for above 10 years or Patients with Parkinson's Disease whose disease duration longer than 15 years.
You may qualify if:
- Idiopathic Parkinson's disease
- Disease duration longer than 15 years
- Had STN deep brain stimulation implant more than 10 years
- Available and willing to be followed-up according to study protocol
You may not qualify if:
- Patients with serious diseases such as tumor, sever liver or kidney dysfunction were not selected in the clinical trials
- Epilepsy
- Pregnant female
- History of severe neuropsychiatric disease
- Patients are taking part in other clinical trials in recent several months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
Study Sites (1)
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Haiyan Zhou
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
- PRINCIPAL INVESTIGATOR
Dianyou Li
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
- PRINCIPAL INVESTIGATOR
Bomin Sun
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
- PRINCIPAL INVESTIGATOR
Wei Hu
University of Florida
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 24, 2017
First Posted
July 26, 2017
Study Start
July 24, 2017
Primary Completion
May 1, 2019
Study Completion
May 1, 2019
Last Updated
March 11, 2020
Record last verified: 2020-03