An observational study in Parkinson Disease, sponsored by Chen Ling. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-09-26.
Sponsored by Chen Ling · Observational
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 200 is above the median of 96 across 1,057 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Chen Ling is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population are PD Patients with motor complications and an intention of receiving DBS.
Exclusion Criteria:
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.
Device: Bilateral deep brain stimulation of the subthalamic nucleus
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.
Device: Bilateral deep brain stimulation of the subthalamic nucleus
Also known as: Activa PC or RC neurostimulator, Medtronic
Changes in 39-item Parkinson's disease questionnaire (PDQ-39) scores
Quality of life
Time frame: From baseline to 4 years
Changes in Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III scores
Motor function
Time frame: From baseline to 4 years
Changes in time spent in the "on" state without troubling dyskinesia based on Parkinson's disease home diary
Good "on" time
Time frame: 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
Time frame: From baseline to 4 years
Severe adverse effects
Safety profile
Time frame: From baseline to 4 years
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chen Ling