Closed-loop DBS in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06012461
• Other study ID #: CDBS_PD_2023
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: August 2023
• Source: Tsinghua University
• Contact: Weizhi Pan, B.S.
• Phone: +86-010-62796172
• Email: neln[@]mail.tsinghua.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
China	National Engineering Research Center of Neuromodulation	Beijing	Beijing

Sponsors (5)

Lead Sponsor	Collaborator
Tsinghua University	Beijing Pins Medical Co., Ltd, Beijing Tiantan Hospital, National Engineering Research Center of Neuromodulation, Tsinghua University, Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

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