Clinical trial NCT01922388: Early Versus Late Application of STN DBS to PD Patients With Motor Complications
Official title: Early Versus Late Application of Subthalamic Deep Brain Stimulation to Parkinson's Disease Patients With Motor Complications: a Multicentre, Prospective and Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: Parkinson disease
deep brain stimulation
subthalamic nucleus
motor complication
quality of life
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Prince of Wales Hospital, Shatin, Hong Kong
name: Shenzhen Second People's Hospital
First posted: 2013-08-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population are PD Patients with motor complications and an intention of receiving DBS.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in 39-item Parkinson's disease questionnaire (PDQ-39) scores
timeFrame: From baseline to 4 years
Secondary outcomes:
measure: Changes in Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III scores
timeFrame: From baseline to 4 years
measure: Changes in time spent in the "on" state without troubling dyskinesia based on Parkinson's disease home diary
timeFrame: From baseline to 4 years
measure: Changes in MDS-UPDRS patient questionnaire (Part I B and Part II) scores
timeFrame: From baseline to 4 years
measure: Severe adverse effects
timeFrame: From baseline to 4 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Ling Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.