Closed-loop DBS in Parkinson's Disease

Not Applicable

Recruiting

• Conditions: Parkinson Disease
• Interventions: 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

• Registration Number: NCT06012461
• Lead Sponsor: Tsinghua University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-18
• Study Start: 2023-06-30
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-19
• Study First Posted: 2023-08-25
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-09-05
• Primary Completion: 2024-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bilateral STN DBS Modulation	Closed-loop DBS stimulation for 24 hours	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.
Bilateral STN DBS Modulation	Closed-loop DBS stimulation for 72 hours	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.
Bilateral STN DBS Modulation	Open-loop DBS stimulation for 24 hours	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.
Bilateral STN DBS Modulation	Open-loop DBS stimulation for 72 hours	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.

Primary Outcome Measures

Name	Time	Method
Movement disorders evaluation	1-3 days	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	1-3 nights	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	1-3days	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

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

Trial Locations

Locations (1)

National Engineering Research Center of Neuromodulation; 🇨🇳 Beijing, Beijing, China