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| Name | Class |
|---|---|
| Beijing Tsinghua Changgeng Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DBS Regulation Group | Experimental | All participants will receive STN-DBS sleep regulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STN-DBS stimulation pattern change | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| ratio of slow wave sleep | The percentage of slow wave sleep | through study completion, an average of 1 year |
| ratio of rem sleep | The percentage of rem sleep | through study completion, an average of 1 year |
| Sleep Efficiency | The percentage of time a person sleeps, in relation to the amount of time a person spends in bed | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Motor Function Evaluation | Using MDS-UPDRS III to evaluation motor function both before and after whole night sleep to verify influence of different stimulation pattern on motor function during sleep. | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Engineering Laboratory for Neuromodulation | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |