NCT06914466Recruiting
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
Source: ClinicalTrials.gov · Last updated 6 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 30 Mar 2025
- Start date
- 1 Sept 2024
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Xuanwu Hospital, Beijing
- Diseases
- Parkinson disease
- NCT number
- NCT06914466
What you commit to
- Study type: Observational
- Planned participants: 20
- From 1 Sept 2024 to the primary completion date, 1 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who underwent other brain surgery;
Other illness
- 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;
Other
- Patients who cannot complete informed consent due to cognitive and communication barriers, or refuse to sign informed consent.
Who the study is looking for
- 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.
Age in the registry: 19 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xuanwu Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.