NCT03230331CompletedNot Applicable
Long Term Study of Subthalamic Deep Brain Stimulation for Parkinson's Disease
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ruijin Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Changs in the score of Stand-Walk-Sit Test
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Patients with serious diseases such as tumor, sever liver or kidney dysfunction were not selected in the clinical trials
- •Pregnant female
- •History of severe neuropsychiatric disease
- •Patients are taking part in other clinical trials in recent several months
Outcomes
Primary Outcomes
Changs in the score of Stand-Walk-Sit Test
Time Frame: above 10 years post surgery
Secondary Outcomes
- UPDRS part II score(above 10 years post surgery)
- Freezing of Gait Questionnaire (FOG-Q) score(above 10 years post surgery)
- Apathy Evaluation Scale score(above 10 years post surgery)
- Change of the score in United Parkinson Disease Rating Scale (UPDRS) part III(above 10 years post surgery)
- 39-Item Parkinson´s Disease Questionnaire (PDQ-39) score(above 10 years post surgery)
- Gait and Falls Questionnaire (GFQ) score(above 10 years post surgery)
- Mini-Mental State Examination (MMSE) score(above 10 years post surgery)
- Frontal Assessment Battery (FAB) score(above 10 years post surgery)
- Hamilton Depression Scale-17 (HAMD-17) score(above 10 years post surgery)
- UPDRS part I score(above 10 years post surgery)
- UPDRS part IV score(above 10 years post surgery)
- Montreal Cognitive Assessment (MoCA) Beijing score Version(above 10 years post surgery)
- Hamilton Anxiety Scale (HAMA) score(above 10 years post surgery)
Investigators
Haiyan Zhou
Principal Investigator
Ruijin Hospital
Study Sites (1)
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