Investigating how deep brain stimulation affects sleep in Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Xuanwu Hospital,Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: yuqing Zhang
• Email: yuqzhang@vip.163.com
• Phone: 010-83922345

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.