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Neuromodulation of Sleep Architecture by STN-DBS in Parkinsonian Patients

Primary Purpose

Parkinson Disease, Sleep Disorder

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
STN-DBS stimulation pattern change
Sponsored by
Tsinghua University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Engineering Laboratory for NeuromodulationRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DBS Regulation Group

Arm Description

All participants will receive STN-DBS sleep regulation.

Outcomes

Primary Outcome Measures

ratio of slow wave sleep
The percentage of slow wave sleep
ratio of rem sleep
The percentage of rem sleep
Sleep Efficiency
The percentage of time a person sleeps, in relation to the amount of time a person spends in bed

Secondary Outcome Measures

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.

Full Information

First Posted
June 16, 2021
Last Updated
May 25, 2023
Sponsor
Tsinghua University
Collaborators
Beijing Tsinghua Changgeng Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04976569
Brief Title
Neuromodulation of Sleep Architecture by STN-DBS in Parkinsonian Patients
Official Title
Neuromodulation of Sleep Architecture by STN-DBS in Parkinsonian Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2021 (Actual)
Primary Completion Date
December 10, 2023 (Anticipated)
Study Completion Date
December 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tsinghua University
Collaborators
Beijing Tsinghua Changgeng Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Sleep Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DBS Regulation Group
Arm Type
Experimental
Arm Description
All participants will receive STN-DBS sleep regulation.
Intervention Type
Device
Intervention Name(s)
STN-DBS stimulation pattern change
Intervention Description
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.
Primary Outcome Measure Information:
Title
ratio of slow wave sleep
Description
The percentage of slow wave sleep
Time Frame
through study completion, an average of 1 year
Title
ratio of rem sleep
Description
The percentage of rem sleep
Time Frame
through study completion, an average of 1 year
Title
Sleep Efficiency
Description
The percentage of time a person sleeps, in relation to the amount of time a person spends in bed
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Motor Function Evaluation
Description
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.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
National Engineering Laboratory for Neuromodulation
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huiling Yu, MD
Email
yuhuiling@mail.tsinghua.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Neuromodulation of Sleep Architecture by STN-DBS in Parkinsonian Patients

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