Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Prince of Wales Hospital, Shatin, Hong Kong | OTHER |
| Shenzhen Second People's Hospital | OTHER |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group I | Voltage adjustment only |
| |
| group II | Multiple parameters adjustment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| voltage adjustment only | Device | Only voltage will be adjusted in all programming sections. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in motor symptoms (tremor, rigidity, bradykinesia and postural stability) evaluated by MDS-UPDRS Part III in off medication /on stimulation state | Motor subscores | From baseline to 12 and 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in 39-item Parkinson's Disease Questionnaire (PDQ-39) scores | Quality of life | From baseline to 12 and 48 months |
| Changes in levodopa equivalent daily dosage (LEDD) | Medication dosage |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
PD Patients are selected from the outpatient department of three centres.
Not provided
| 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 |
|---|---|---|---|
| 29557387 | Derived | Xu SH, Yang C, Xian WB, Gu J, Liu JL, Jiang LL, Ye J, Liu YM, Guo QY, Zheng YF, Wu L, Chen WR, Pei Z, Chen L. Voltage adjustment improves rigidity and tremor in Parkinson's disease patients receiving deep brain stimulation. Neural Regen Res. 2018 Feb;13(2):347-352. doi: 10.4103/1673-5374.226406. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Multiple parameters adjustment |
| Device |
More than one parameter, including voltage, frequency and pulse width, will be adjusted in the programming sections. |
|
| From baseline to 12 and 48 months |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |