NCT06914466 Neural Mechanisms and Clinical Applications of DBS for Modulating Sleep Dysregulation in PD
| NCT ID | NCT06914466 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xuanwu Hospital, Beijing |
| Condition | Deep Brain Stimulation |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2024-09-01 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. 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. 2. Patients who underwent bilateral STN-DBS(Medtronic Percept™ PC) 3. Patients who can cooperate with the completion of postoperative follow-up and clinical evaluation. Exclusion Criteria: 1. Patients who underwent other brain surgery; 2. Other patients with secondary Parkinson's syndrome and Parkinsonism-plus syndrome; 3. Patients with other central nervous system and peripheral nervous system diseases; 4. Patients complicated with severe medical system diseases, or unable to tolerate clinical evaluation; 5. Patients with severe mental illness; 6. Patients who cannot complete informed consent due to cognitive and communication barriers, or refuse to sign informed consent.
Contact & Investigator
yuqing Zhang
STUDY CHAIR
Xuanwu Hospital, Beijing
Frequently Asked Questions
Who can join the NCT06914466 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 80 Years, studying Deep Brain Stimulation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06914466 currently recruiting?
Yes, NCT06914466 is actively recruiting participants. Contact the research team at yuqzhang@vip.163.com for enrollment information.
Where is the NCT06914466 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06914466 clinical trial?
NCT06914466 is sponsored by Xuanwu Hospital, Beijing. The principal investigator is yuqing Zhang at Xuanwu Hospital, Beijing. The trial plans to enroll 20 participants.