Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2023-06-30
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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National Engineering Research Center of Neuromodulation, Tsinghua University
UNKNOWN
Beijing Tiantan Hospital
OTHER
Peking Union Medical College Hospital
OTHER
Beijing Pins Medical Co., Ltd
INDUSTRY
Tsinghua University
OTHER
Responsible Party
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Luming Li
Professor
Locations
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National Engineering Research Center of Neuromodulation
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CDBS_PD_2023
Identifier Type: -
Identifier Source: org_study_id
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