Neuromodulation of Sleep Architecture by STN-DBS in Parkinsonian Patients

NCT04976569 | Unknown DMC

• 1 other identifier: STN_DBS_Sleep_TsinghuaU
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease; Sleep Disorder

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• Motor Function Evaluation

  through study completion, an average of 1 year

Study Arms (1)

DBS Regulation Group

EXPERIMENTAL

All participants will receive STN-DBS sleep regulation.

Device: STN-DBS stimulation pattern change

Interventions

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.

DBS Regulation Group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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;
• Patients with onset age of 50 years and above;
• Do not use phenobarbital, chloral hydrate, benzodiazepines and non-benzodiazepines as sedatives and hypnotics at night.

You may not qualify if:

• Patients who underwent pallidotomy and other brain surgery;
• Other patients with secondary Parkinson's syndrome and Parkinsonism-plus syndrome;
• Patients with other central nervous system and peripheral nervous system diseases;
• Patients complicated with severe medical system diseases, patients with unstable vital signs and unable to tolerate clinical evaluation;
• Patients with severe mental illness;
• Use phenobarbital, chloral hydrate, benzodiazepines and non-benzodiazepines as sedatives and hypnotics at night;
• Patients who cannot complete informed consent due to cognitive and communication barriers, or refuse to sign informed consent.

Sponsors & Collaborators

• Tsinghua University: lead
• Beijing Tsinghua Changgeng Hospital: collaborator

Study Sites (1)

National Engineering Laboratory for Neuromodulation

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: : Director of National Engineering Laboratory for Neuromodulation

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: July 26, 2021
• Study Start: August 10, 2021
• Primary Completion: December 10, 2023
• Study Completion: December 10, 2023
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)