Investigating how deep brain stimulation affects sleep in Parkinson's disease
Neural Mechanisms and Clinical Applications of Deep Brain Stimulation for Modulating Sleep Dysregulation in Parkinson's Disease
This study is testing how deep brain stimulation affects sleep in people with Parkinson's disease to see if it can help improve their sleep quality.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06914466 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on understanding the neural mechanisms by which deep brain stimulation (DBS) of the subthalamic nucleus (STN) influences sleep regulation in patients with Parkinson's disease (PD). It will enroll 20 patients who have undergone bilateral STN-DBS and utilize wearable polysomnography (PSG) to monitor sleep patterns before and after DBS optimization. The study aims to correlate sleep architecture and local field potentials (LFPs) with clinical outcomes, employing machine learning to identify biomarkers that predict sleep improvement. The findings could lead to enhanced DBS strategies for managing sleep disorders in PD patients.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with idiopathic Parkinson's disease who have undergone bilateral STN-DBS.
Not a fit: Patients with secondary Parkinson's syndrome or those with severe mental illness may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve sleep quality and overall quality of life for patients with Parkinson's disease.
How similar studies have performed: While some preliminary studies suggest DBS may improve sleep, this specific approach utilizing PSG and LFPs is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Xuanwu Hospital,Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: yuqing Zhang
- Email: yuqzhang@vip.163.com
- Phone: 010-83922345
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.