RecruitingNCT06914466

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

Neural Mechanisms and Clinical Applications of Deep Brain Stimulation for Modulating Sleep Dysregulation in Parkinson's Disease


Sponsor

Xuanwu Hospital, Beijing

Enrollment

20 participants

Start Date

Sep 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 19 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how deep brain stimulation (DBS) — a surgically implanted device that sends electrical signals to specific brain areas — affects sleep problems in people with Parkinson's disease, and how different DBS settings influence sleep quality. **You may be eligible if...** - You have a confirmed diagnosis of Parkinson's disease - You have had bilateral deep brain stimulation surgery using a specific device (Medtronic Percept PC) - You are able to attend follow-up appointments and complete evaluations **You may NOT be eligible if...** - You have had other brain surgery besides DBS - You have another form of parkinsonism that is not idiopathic Parkinson's disease - You have other significant neurological or medical conditions - You have severe mental illness - You are unable to provide informed consent due to cognitive or communication difficulties Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREDeep Brain Stimulation

Deep Brain Stimulation


Locations(1)

Xuanwu Hospital,Capital Medical University

Beijing, Beijing Municipality, China

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NCT06914466


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