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| Name | Class |
|---|---|
| Prince of Wales Hospital, Shatin, Hong Kong | OTHER |
| Shenzhen Second People's Hospital | OTHER |
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Although deep brain stimulation of the subthalamic nucleus(STN DBS) has become the surgical treatment of choice for Parkinson's disease(PD), a consensus on the timing of surgery is lacking. This study is intended to demonstrate that early, compared with delayed, introduction of STN DBS is more beneficial for PD patients who have developed motor complications.
In this prospective study, 200 PD patients will be recruited for STN DBS over three years, including 133 with motor complications existing for more than three years (late complication group) and 67 less than three years (early complication group). To make a comparison of therapeutic efficacy between the two groups, motor and non-motor symptoms will be assessed using specific rating scales and questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Motor Complication | This group is composed of PD patients with motor complications of 3 years or less. All subjects receive bilateral deep brain stimulation of the subthalamic nucleus and best medical treatment. |
| |
| Late Motor Complication | This group is composed of PD patients with motor complications of more than 3 years. All subjects receive bilateral deep brain stimulation of the subthalamic nucleus and best medical treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral deep brain stimulation of the subthalamic nucleus | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in 39-item Parkinson's disease questionnaire (PDQ-39) scores | Quality of life | From baseline to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III scores | Motor function | From baseline to 4 years |
| Changes in time spent in the "on" state without troubling dyskinesia based on Parkinson's disease home diary |
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Inclusion Criteria:
Exclusion Criteria:
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The study population are PD Patients with motor complications and an intention of receiving DBS.
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| Name | Affiliation | Role |
|---|---|---|
| Ling Chen, MD, PhD | First Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29150478 | Derived | Jiang L, Poon WS, Moro E, Xian W, Yang C, Zhu XL, Gu J, Cai X, Liu J, Mok V, Liu Y, Xu S, Guo Q, Chen W, Chen L. Early versus Late Application of Subthalamic deep brain Stimulation to Parkinson's disease patients with motor complications (ELASS): protocol of a multicentre, prospective and observational study. BMJ Open. 2017 Nov 16;7(11):e018610. doi: 10.1136/bmjopen-2017-018610. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Good "on" time |
| From baseline to 4 years |
| Changes in MDS-UPDRS patient questionnaire (Part I B and Part II) scores | Motor and non-motor experiences of daily living | From baseline to 4 years |
| Severe adverse effects | Safety profile | From baseline to 4 years |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |