Back to resultsClosed-loop DBS in Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Closed-loop DBS stimulation for 24 hours
Open-loop DBS stimulation for 24 hours
Closed-loop DBS stimulation for 72 hours
Open-loop DBS stimulation for 72 hours
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Deep Brain Stimulation, Closed-loop DBS
Eligibility Criteria
Inclusion Criteria: Diagnosis of primary Parkinson's disease: Diagnosis of primary Parkinson's disease should meet the diagnostic criteria outlined in the "Diagnosis Standards for Parkinson's Disease in China" published in 2016 or the diagnostic criteria for primary Parkinson's disease by the International Parkinson and Movement Disorder Society (MDS) published in 2015. Good response to levodopa combination therapy. Significant reduction in drug efficacy or significant impact on the patient's quality of life due to prominent motor complications. Intolerable adverse reactions to medication affecting its efficacy. Presence of uncontrollable tremors despite medication. Exclusion Criteria: Patients who have undergone pallidotomy or other brain surgeries. Patients with secondary Parkinson syndromes or Parkinson plus syndromes. Patients with concurrent central nervous system and peripheral nervous system diseases. Patients with severe systemic diseases, unstable vital signs, or those who cannot tolerate clinical assessments. Patients with severe psychiatric disorders. Patients who are unable to provide informed consent due to cognitive or communication impairments or those who refuse to sign the informed consent form.
Sites / Locations
- National Engineering Research Center of NeuromodulationRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bilateral STN DBS Modulation
Arm Description
Participants will be implanted with bilateral STN DBS using PINS 106RS system. DBS stimulation will be initiated one month post surgery. Follow-up visits will be conducted 1/3/6/9/12/15 months post surgery with clinical evaluation, STN LFP recording and resting state functional MRI testing. During the 6-15 month's visit, short-term closed-loop DBS modulation (from 24hours to 72hours ) will be conducted to test the safety and efficacy of closed-loop DBS therapy.
Outcomes
Primary Outcome Measures
Movement disorders evaluation
Using MDS-UPDRS III rating scale （0-132, the higher score means a worse outcome） and Rush dyskinesia rating scale （0-12, the higher score means a worse outcome） combined with IMU to evaluate the motor function improvement under both closed-loop DBS and open-loop DBS condition
Sleep Structure Evaluation
Using polysomnography evaluation （sleep efficiency，N1/N2/N3/REM/Wake after sleep onset duration and percentage，arousal index） and subjuective sleep quality rating scale to evaluate the sleep improvement under both closed-loop DBS and open-loop DBS condition
Diary Outcomes in Parkinson's Disease
Using SCOPA-DC （0-87, the higher score means a worse outcome） to evaluate the diary outcomes under both closed-loop DBS and open-loop DBS condition
Secondary Outcome Measures
Safety (Stimulation-related AEs) and Subjective Satisfactory
Number of modulation related Adverse Events or abnormal vital signs.
Total Electrical Energy Delivered to patients
To evaluate the energy changes in closed-loop DBS and open-loop DBS modualtion
Full Information
NCT ID
NCT06012461
First Posted
June 18, 2023
Last Updated
August 30, 2023
Sponsor
Tsinghua University
Collaborators
National Engineering Research Center of Neuromodulation, Tsinghua University, Beijing Tiantan Hospital, Peking Union Medical College Hospital, Beijing Pins Medical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT06012461
Brief Title
Closed-loop DBS in Parkinson's Disease
Official Title
Safety and Effectiveness of Closed-loop DBS in Parkinson's Disease: A Long-term Follow-up Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2023 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tsinghua University
Collaborators
National Engineering Research Center of Neuromodulation, Tsinghua University, Beijing Tiantan Hospital, Peking Union Medical College Hospital, Beijing Pins Medical Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Closed-loop DBS is an emerging neuromodulation pattern in Parkinson's disease with dyanmic adjustment of stimulation parameters to patients' disease fluctuations and state of activity. The purpose of this study is to verify the long-term safety and effectiveness of closed-loop DBS. Through comparing with open-loop DBS, the study also determine whether closed-loop DBS is more effective than conventional open-loop DBS on PD treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, Deep Brain Stimulation, Closed-loop DBS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bilateral STN DBS Modulation
Arm Type
Experimental
Arm Description
Participants will be implanted with bilateral STN DBS using PINS 106RS system. DBS stimulation will be initiated one month post surgery. Follow-up visits will be conducted 1/3/6/9/12/15 months post surgery with clinical evaluation, STN LFP recording and resting state functional MRI testing. During the 6-15 month's visit, short-term closed-loop DBS modulation (from 24hours to 72hours ) will be conducted to test the safety and efficacy of closed-loop DBS therapy.
Intervention Type
Other
Intervention Name(s)
Closed-loop DBS stimulation for 24 hours
Intervention Description
Continuous closed-loop modulation for 24 hours
Intervention Type
Other
Intervention Name(s)
Open-loop DBS stimulation for 24 hours
Intervention Description
Continuous open-loop modulation for 24 hours
Intervention Type
Other
Intervention Name(s)
Closed-loop DBS stimulation for 72 hours
Intervention Description
Continuous closed-loop modulation for 72 hours
Intervention Type
Other
Intervention Name(s)
Open-loop DBS stimulation for 72 hours
Intervention Description
Continuous open-loop modulation for 72 hours
Primary Outcome Measure Information:
Title
Movement disorders evaluation
Description
Using MDS-UPDRS III rating scale （0-132, the higher score means a worse outcome） and Rush dyskinesia rating scale （0-12, the higher score means a worse outcome） combined with IMU to evaluate the motor function improvement under both closed-loop DBS and open-loop DBS condition
Time Frame
1-3 days
Title
Sleep Structure Evaluation
Description
Using polysomnography evaluation （sleep efficiency，N1/N2/N3/REM/Wake after sleep onset duration and percentage，arousal index） and subjuective sleep quality rating scale to evaluate the sleep improvement under both closed-loop DBS and open-loop DBS condition
Time Frame
1-3 nights
Title
Diary Outcomes in Parkinson's Disease
Description
Using SCOPA-DC （0-87, the higher score means a worse outcome） to evaluate the diary outcomes under both closed-loop DBS and open-loop DBS condition
Time Frame
1-3days
Secondary Outcome Measure Information:
Title
Safety (Stimulation-related AEs) and Subjective Satisfactory
Description
Number of modulation related Adverse Events or abnormal vital signs.
Time Frame
1-3days
Title
Total Electrical Energy Delivered to patients
Description
To evaluate the energy changes in closed-loop DBS and open-loop DBS modualtion
Time Frame
1-3days
Other Pre-specified Outcome Measures:
Title
Neurophysiological changes of STN-LFP in daytime and sleep
Description
Changes of the power and entropy features of delta, theta, alpha, beta and gamma oscillations
Time Frame
at 3,6,9,12,15 months compared to baseline
Title
Functional connectivity changes during long-term DBS modulation
Description
Changes of subcortical and cortical functional connectivity
Time Frame
at 3,6,9,12,15 months compared to baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of primary Parkinson's disease: Diagnosis of primary Parkinson's disease should meet the diagnostic criteria outlined in the "Diagnosis Standards for Parkinson's Disease in China" published in 2016 or the diagnostic criteria for primary Parkinson's disease by the International Parkinson and Movement Disorder Society (MDS) published in 2015.
Good response to levodopa combination therapy.
Significant reduction in drug efficacy or significant impact on the patient's quality of life due to prominent motor complications.
Intolerable adverse reactions to medication affecting its efficacy.
Presence of uncontrollable tremors despite medication.
Exclusion Criteria:
Patients who have undergone pallidotomy or other brain surgeries.
Patients with secondary Parkinson syndromes or Parkinson plus syndromes.
Patients with concurrent central nervous system and peripheral nervous system diseases.
Patients with severe systemic diseases, unstable vital signs, or those who cannot tolerate clinical assessments.
Patients with severe psychiatric disorders.
Patients who are unable to provide informed consent due to cognitive or communication impairments or those who refuse to sign the informed consent form.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weizhi Pan, B.S.
Phone
+86-010-62796172
Email
neln@mail.tsinghua.edu.cn
Facility Information:
Facility Name
National Engineering Research Center of Neuromodulation
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100084
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huiling Yu, M.D.
Phone
86-010-62794952
Email
hellokittylene@163.com
First Name & Middle Initial & Last Name & Degree
Luming Li, Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Closed-loop DBS in Parkinson's Disease
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