Closed-loop DBS in Parkinson's Disease

Safety and Effectiveness of Closed-loop DBS in Parkinson's Disease: A Long-term Follow-up Study

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Closed-loop DBS stimulation for 24 hours; Other: Open-loop DBS stimulation for 24 hours; Other: Closed-loop DBS stimulation for 72 hours; Other: Open-loop DBS stimulation for 72 hours

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weizhi Pan, B.S.; Phone Number: +86-010-62796172; Email: neln@mail.tsinghua.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100084
      • Recruiting
      • National Engineering Research Center of Neuromodulation
      • Contact: Huiling Yu, M.D.; Phone Number: 86-010-62794952; Email: hellokittylene@163.com
      • Principal Investigator: Luming Li, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. Good response to levodopa combination therapy.
3. Significant reduction in drug efficacy or significant impact on the patient's quality of life due to prominent motor complications.
4. Intolerable adverse reactions to medication affecting its efficacy.
5. Presence of uncontrollable tremors despite medication.

Exclusion Criteria:

1. Patients who have undergone pallidotomy or other brain surgeries.
2. Patients with secondary Parkinson syndromes or Parkinson plus syndromes.
3. Patients with concurrent central nervous system and peripheral nervous system diseases.
4. Patients with severe systemic diseases, unstable vital signs, or those who cannot tolerate clinical assessments.
5. Patients with severe psychiatric disorders.
6. Patients who are unable to provide informed consent due to cognitive or communication impairments or those who refuse to sign the informed consent form.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Bilateral STN DBS Modulation; 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.

Other: Closed-loop DBS stimulation for 24 hours; Continuous closed-loop modulation for 24 hours; Other: Open-loop DBS stimulation for 24 hours; Continuous open-loop modulation for 24 hours; Other: Closed-loop DBS stimulation for 72 hours; Continuous closed-loop modulation for 72 hours; Other: Open-loop DBS stimulation for 72 hours; Continuous open-loop modulation for 72 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1-3 days
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	1-3 nights
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	1-3days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety (Stimulation-related AEs) and Subjective Satisfactory	Number of modulation related Adverse Events or abnormal vital signs.	1-3days
Total Electrical Energy Delivered to patients	To evaluate the energy changes in closed-loop DBS and open-loop DBS modualtion	1-3days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurophysiological changes of STN-LFP in daytime and sleep	Changes of the power and entropy features of delta, theta, alpha, beta and gamma oscillations	at 3,6,9,12,15 months compared to baseline
Functional connectivity changes during long-term DBS modulation	Changes of subcortical and cortical functional connectivity	at 3,6,9,12,15 months compared to baseline

Collaborators and Investigators

• Sponsor: Tsinghua University
• Collaborators: Peking Union Medical College Hospital; Beijing Tiantan Hospital; Beijing Pins Medical Co., Ltd; National Engineering Research Center of Neuromodulation, Tsinghua University

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2023
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: June 18, 2023
• First Submitted That Met QC Criteria: August 19, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Parkinson Disease; Deep Brain Stimulation; Closed-loop DBS
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: CDBS_PD_2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No