Closed-loop DBS is an emerging neuromodulation pattern in Parkinson's disease with dyanmic adjustment of stimulation parameters to patients' disease fluctuations and state of activity. The purpose of this study is to verify the long-term safety and effectiveness of closed-loop DBS. Through comparing with open-loop DBS, the study also determine whether closed-loop DBS is more effective than conventional open-loop DBS on PD treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Continuous closed-loop modulation for 24 hours
Continuous open-loop modulation for 24 hours
Continuous closed-loop modulation for 72 hours
National Engineering Research Center of Neuromodulation
Beijing, Beijing Municipality, China
RECRUITINGMovement disorders evaluation
Using MDS-UPDRS III rating scale (0-132, the higher score means a worse outcome) and Rush dyskinesia rating scale (0-12, the higher score means a worse outcome) combined with IMU to evaluate the motor function improvement under both closed-loop DBS and open-loop DBS condition
Time frame: 1-3 days
Sleep Structure Evaluation
Using polysomnography evaluation (sleep efficiency,N1/N2/N3/REM/Wake after sleep onset duration and percentage,arousal index) and subjuective sleep quality rating scale to evaluate the sleep improvement under both closed-loop DBS and open-loop DBS condition
Time frame: 1-3 nights
Diary Outcomes in Parkinson's Disease
Using SCOPA-DC (0-87, the higher score means a worse outcome) to evaluate the diary outcomes under both closed-loop DBS and open-loop DBS condition
Time frame: 1-3days
Safety (Stimulation-related AEs) and Subjective Satisfactory
Number of modulation related Adverse Events or abnormal vital signs.
Time frame: 1-3days
Total Electrical Energy Delivered to patients
To evaluate the energy changes in closed-loop DBS and open-loop DBS modualtion
Time frame: 1-3days
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Continuous open-loop modulation for 72 hours