Neural Mechanisms and Clinical Applications of DBS for Modulating Sleep Dysregulation in PD
Recruiting · NCT06914466 · Observational (researchers observe without assigning treatment) · Lead sponsor: Xuanwu Hospital, Beijing
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Parkinson's disease (PD) is a prevalent neurodegenerative disorder characterized by both motor and non-motor symptoms. Subthalamic nucleus (STN) deep brain stimulation (DBS) effectively alleviates motor symptoms; however, non-motor symptoms such as sleep disorders significantly impair patients' quality of life. While preliminary evidence suggests DBS may improve sleep, the underlying neural mechanisms and long-term effects on sleep regulation remain poorly elucidated. This study employs a wearable polysomnography (PSG) device to investigate how STN-DBS modulates sleep architecture, local field potentials (LFPs), and clinical outcomes in PD patients. We hypothesize that STN-DBS contributes to both the regulation and disruption of normal sleep behavior. By synchronizing PSG with STN-LFP recordings under DBS-ON and DBS-OFF conditions, we aim to decode sleep stages using STN-LFPs, characterize PD-specific sleep abnormalities (e.g., sleep architecture, atonia), and analyze DBS-induced LFP changes and their correlations with clinical efficacy. According to the above data, the sleep stage characteristics were decoded, and the algorithm was used to determine the optimal clinical threshold current amplitude to improve sleep. Then, the patients will be given adaptive stimulation, and the sleep quality was monitored to verify its efficacy.This study will provide a neurophysiological foundation for developing closed-loop stimulation strategies targeting sleep dysfunction in PD.
Who can take part
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.
Where it is running
1 location listed.
- Xuanwu Hospital,Capital Medical University - Beijing, Beijing Municipality, China