NCT04976569

Neuromodulation of Sleep Architecture by STN-DBS in Parkinsonian Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Tsinghua University · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Sleep disorder is one of the most burdensome non-motor symptoms in Parkinsonian patients. Typical manifestations include RBD, decreased sleep efficiency, decreased slow wave sleep, daytime sleepiness, increased sleep latency and wakefulness during sleep. Subthalamic nucleus (STN) deep brain stimulation (DBS) has been reported to improve sleep dysfunction in several studies, mostly due to its improvement in motor dysfunction. However, there are limited research about specific STN-DBS stimulation pattern for sleep architecture regulation, and whether suboptimal parameter combinations for motor has potential benefits for sleep improvement has not been studied. Here we use different parameter combination in STN-DBS, especially by changing stimulation contact and frequency, to explore the specific stimulation pattern for normalizing sleep architecture and increasing slow wave sleep.

Detailed description

Investigators will enroll at least 5 subjects for this study. First, subjects will be clinically evaluated by motor, cognitive and sleep scales; Subsequently, the treatment window of each contact using unipolar stimulation will be tested both in high frequency (such as 130Hz) and low frequency (such as 80Hz), and the parameters of stimulation were determined under the premise of no obvious discomfort and optimal motor control. Different stimulation pattern (such as ventral contact stimulation) will be performed during the N2 phase combined with PSG and LFP recording during the patients' sleep, and switch to baseline stimulation pattern at the N3/N1/REM phase. Repeat these steps until the patient wake up naturally. Finally, the patients will be evaluated for motor function. Pre-surgery and post-surgery images will be used for reconstructing VTA of specific parameter combination. Functional MRI (fMRI) will be carried out to verify the connectivity change under optimal parameter combinations.

Conditions

• Parkinson Disease
• Sleep Disorder

Interventions

Type	Name	Description
DEVICE	STN-DBS stimulation pattern change	Deep brain stimulation (DBS) is an elective surgical procedure in which electrodes are implanted into certain brain areas.We use specific STN-DBS stimulation pattern to regulate sleep architecture.

Timeline

• Start date: 2021-08-10
• Primary completion: 2023-12-10
• Completion: 2023-12-10
• First posted: 2021-07-26
• Last updated: 2023-05-30

Locations

1 site across 1 country: China