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

NCT06914466 | Recruiting

• 1 other identifier: 20250322
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Deep Brain Stimulation; Parkinson's Disease and Parkinsonism; Sleep Disorder

Outcome Measures

Primary Outcomes (2)

• Duration of REM sleep stage

  Sleep fragmentation frequency and duration will be measured using PSG

  12 months

• 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.

  12 months

Interventions

Deep Brain Stimulation PROCEDURE

Deep Brain Stimulation

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital,Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders; Sleep Wake Disorders

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• yuqing Zhang

  Xuanwu Hospital, Beijing

  STUDY CHAIR

Central Study Contacts

yuqing Zhang

CONTACT

010-83922345; yuqzhang@vip.163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2025
• First Posted: April 6, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-03

Locations

CN (1)