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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19-80
SponsorXuanwu Hospital, Beijing

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial population

Patients with Parkinson's Disease who 2.underwent bilateral STN-DBS(Medtronic Percept™ PC) and consent to participate in the sleep study.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Deep Brain Stimulation

    Procedure/Surgery

    Deep Brain Stimulation

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Duration of REM sleep stage

Sleep fragmentation frequency and duration will be measured using PSG

Time frame
12 months
2

Subjective Sleep Quality

Change in subjective sleep quality will be measured between the different conditions. The measure will be captured using the Parkinson's disease sleep scale, PDSS.

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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