Parkinson Disease
Conditions
Keywords
Parkinson disease, deep brain stimulation, subthalamic nucleus, motor complication, quality of life
Brief summary
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.
Detailed description
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.
Interventions
DEVICEBilateral deep brain stimulation of the subthalamic nucleus
Sponsors
Prince of Wales Hospital, Shatin, Hong Kong
Shenzhen Second People's Hospital
Chen Ling
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Idiopathic Parkinson's Disease with good response to levodopa(i.e. more than 30% improvement in the MDS-UPDRS Part III score after an acute levodopa challenge) * Presence of fluctuations and/or dyskinesias * Age ranging from 18 to 75 years old * Normal brain MRI * Absence of dementia (Mini Mental State Examination ≥ 26) * Absence of severe psychiatric diseases * Written informed consent
Exclusion criteria
* Presence of severe metabolic diseases * Severe cardiac/respiratory/renal/hepatic diseases * Secondary parkinsonism or multiple system atrophy * Illiteracy or insufficient language skills to complete the questionnaires * Poor compliance and unreasonable expectation * Women who are pregnant or breast feeding * Simultaneous participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in 39-item Parkinson's disease questionnaire (PDQ-39) scores | From baseline to 4 years | Quality of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III scores | From baseline to 4 years | Motor function |
| Changes in time spent in the on state without troubling dyskinesia based on Parkinson's disease home diary | From baseline to 4 years | Good on time |
| Changes in MDS-UPDRS patient questionnaire (Part I B and Part II) scores | From baseline to 4 years | Motor and non-motor experiences of daily living |
| Severe adverse effects | From baseline to 4 years | Safety profile |
Countries
China
Outcome results
None listed