Actively Recruiting

Age: 19Years - 80Years
All Genders
NCT06914466

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

Led by Xuanwu Hospital, Beijing · Updated on 2025-04-06

20

Participants Needed

1

Research Sites

117 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 19Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Parkinson's disease confirmed by three experienced neurologists using UK PD Society Brain Bank Clinical Diagnostic Criteria or 2015 MDS Clinical Diagnostic Criteria
  • Patients who have undergone bilateral STN-DBS with Medtronic Percept2 PC device
  • Ability to cooperate with and complete postoperative follow-up and clinical evaluations
Not Eligible

You will not qualify if you...

  • History of other brain surgery
  • Diagnosis of secondary Parkinson's syndrome or Parkinsonism-plus syndrome
  • Presence of other central or peripheral nervous system diseases
  • Severe medical system diseases or inability to tolerate clinical evaluations
  • Severe mental illness
  • Inability to provide informed consent due to cognitive or communication barriers or refusal to sign consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Xuanwu Hospital,Capital Medical University

Beijing, Beijing Municipality, China, 100053

Actively Recruiting

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Research Team

Y

yuqing Zhang

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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