Neural Mechanisms and Clinical Applications of DBS for Modulating Sleep Dysregulation in PD

This single-center longitudinal observational study will enroll 20 idiopathic Parkinson's disease (PD) patients with bilateral subthalamic nucleus (STN) deep brain stimulation (DBS) systems (Medtronic Percept™ PC) to evaluate the neurophysiological mechanisms of DBS in sleep regulation. Participants will undergo preoperative clinical assessments (MDS-UPDRS III for motor symptoms, NMSS for non-motor symptoms, PDSS for sleep-specific dysfunction) and two nights of wearable PSG recordings. Postoperatively, DBS parameters will be optimized at 1 month for motor symptom control. Follow-up evaluations at 3, 6, and 12 months post-operation include in-hospital PSG and local field potential (LFP) recordings: Night 1 captures data under DBS-OFF conditions, followed by Night 2 with DBS-ON under optimized programming, alongside repeated clinical assessments. Sleep architecture (NREM/REM stages, arousal indices,atonia) and STN-LFPs will be analyzed and correlated with clinical outcomes. Machine learning models will identify LFP biomarkers predictive of sleep improvement to inform closed-loop stimulation strategies. Based on the machine learning results, we will investigate the adaptive algorithm and validate its effectiveness in the second phase. Adaptive stimulation will be administered for one month, followed by two consecutive nights of polysomnography (PSG) monitoring and Parkinson's Disease Sleep Scale (PDSS) assessments at the study interval endpoint. Subsequently, patients will undergo routine open-loop stimulation for one month, with two additional consecutive nights of PSG monitoring and PDSS evaluations conducted upon completion of this phase. Sleep improvement outcomes will be systematically compared between the two stimulation modalities.

Inclusion criteria

• Diagnosis of Parkinson's disease: The diagnostic criteria for Parkinson's disease are the Clinical Diagnostic Criteria of UK PD Society Brain Bank Clinical Diagnostic Criteria or 2015 MDS Clinical Diagnostic Criteria for PD.All diagnoses of Parkinson's disease were made by three neurologists who were experienced in the field of movement disorders.
• Patients who underwent bilateral STN-DBS(Medtronic Percept™ PC)
• Patients who can cooperate with the completion of postoperative follow-up and clinical evaluation.

Exclusion criteria

• Patients who underwent other brain surgery;
• Other patients with secondary Parkinson's syndrome and Parkinsonism-plus syndrome;
• Patients with other central nervous system and peripheral nervous system diseases;
• Patients complicated with severe medical system diseases, or unable to tolerate clinical evaluation;
• Patients with severe mental illness;
• Patients who cannot complete informed consent due to cognitive and communication barriers, or refuse to sign informed consent.