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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
National Engineering Research Center of Neuromodulation
RECRUITING
Beijing
Contact Information
Primary
Weizhi Pan, B.S.
neln@mail.tsinghua.edu.cn
+86-010-62796172
Time Frame
Start Date: 2023-06-30
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 10
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Peking Union Medical College Hospital, Beijing Pins Medical Co., Ltd, National Engineering Research Center of Neuromodulation, Tsinghua University, Beijing Tiantan Hospital
Leads: Tsinghua University

This content was sourced from clinicaltrials.gov