An observational study in Parkinson's 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 2023-09-28.
Sponsored by Chen Ling · Observational
The programming of subthalamic nucleus (STN) deep brain stimulation (DBS) for Parkinson's disease (PD) is complex work because the parameter setting has not been standardized so far. The objective of the present study is to set up a standardized programming algorithm for Chinese PD patients treated with bilateral STN DBS.
A total of 150 subjects will be recruited from the concurrent NCT01922388 study and followed up for four years. All patients will be evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III at baseline (one week before surgery) and at 12 and 48 months postoperatively.
Stimulation parameters setting: The first programming is performed at 4 weeks after surgery. Bilateral contacts are as cathode for monopolar configuration. The initial voltage, pulse width and frequency are bilaterally 1.0-1.5 V, 60 μs and 130 Hz for each individual, respectively. Voltage is gradually increased to a stable level first, until the optimal efficacy is achieved. Two weeks later, when patients came back to hospital for reprogramming, the voltage is also first adjusted to optimize the stimulation parameters. Either pulse width or frequency will be adjusted when increasing voltage more than 0.4 V for one time still can not get satisfactory outcomes. The frequency is adjusted when bilateral symptoms are unresponsive to voltage. Frequency is increased by 15-20 Hz for each time. Pulse width is then adjusted for the satisfactory clinical response of unilateral symptoms which are not satisfied after increasing voltage or frequency. Pulse width is increased to 90 μs if necessary (e.g. severe tremor).
Groups: Patients are divided into two groups according to the parameter settings during follow-up. Group I: patients with voltage adjustment only. The pulse width is kept to 60 μs and frequency to 130 Hz constant throughout the follow-up period. Group II: patients with adjustment of more than two stimulation parameters (voltage, pulse width or frequency) during the follow-up.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 150 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.
PD Patients are selected from the outpatient department of three centres.
Exclusion Criteria:
Voltage adjustment only
Device: voltage adjustment only
Multiple parameters adjustment
Device: Multiple parameters adjustment
Only voltage will be adjusted in all programming sections.
More than one parameter, including voltage, frequency and pulse width, will be adjusted in the programming sections.
Changes in motor symptoms (tremor, rigidity, bradykinesia and postural stability) evaluated by MDS-UPDRS Part III in off medication /on stimulation state
Motor subscores
Time frame: From baseline to 12 and 48 months
Changes in 39-item Parkinson's Disease Questionnaire (PDQ-39) scores
Quality of life
Time frame: From baseline to 12 and 48 months
Changes in levodopa equivalent daily dosage (LEDD)
Medication dosage
Time frame: From baseline to 12 and 48 months
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Chen Ling