Neuromodulation of Sleep Architecture by STN-DBS in Parkinsonian Patients

Parkinson Disease Clinical Trial

Official title:

Neuromodulation of Sleep Architecture by STN-DBS in Parkinsonian Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04976569
• Other study ID #: STN_DBS_Sleep_TsinghuaU
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2021
• Est. completion date: December 10, 2023

Study information

• Verified date: May 2023
• Source: Tsinghua University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: December 10, 2023
• Est. primary completion date: December 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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. Bilateral STN-DBS has been implanted for more than 1 year, and stable drug therapy regimen and parameter program control regimen have been maintained for 6 weeks or more;

3. Patients with onset age of 50 years and above;

4. Do not use phenobarbital, chloral hydrate, benzodiazepines and non-benzodiazepines as sedatives and hypnotics at night.

Exclusion Criteria:

1. Patients who underwent pallidotomy and 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, patients with unstable vital signs and unable to tolerate clinical evaluation;

5. Patients with severe mental illness;

6. Use phenobarbital, chloral hydrate, benzodiazepines and non-benzodiazepines as sedatives and hypnotics at night;

7. Patients who cannot complete informed consent due to cognitive and communication barriers, or refuse to sign informed consent.

Related Conditions & MeSH terms

• Parkinson Disease
• Sleep Disorder
• Sleep Wake Disorders

Intervention

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.

Locations

Country	Name	City	State
China	National Engineering Laboratory for Neuromodulation	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Tsinghua University	Beijing Tsinghua Changgeng Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ratio of slow wave sleep	The percentage of slow wave sleep	through study completion, an average of 1 year
Primary	ratio of rem sleep	The percentage of rem sleep	through study completion, an average of 1 year
Primary	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
Secondary	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