Status:
UNKNOWN
Closed-loop DBS in Parkinson's Disease
Lead Sponsor:
Tsinghua University
Collaborating Sponsors:
National Engineering Research Center of Neuromodulation, Tsinghua University
Beijing Tiantan Hospital
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-70 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patients who have undergone pallidotomy or other brain surgeries.
- Patients with secondary Parkinson syndromes or Parkinson plus syndromes.
- Patients with concurrent central nervous system and peripheral nervous system diseases.
- Patients with severe systemic diseases, unstable vital signs, or those who cannot tolerate clinical assessments.
- Patients with severe psychiatric disorders.
- Patients who are unable to provide informed consent due to cognitive or communication impairments or those who refuse to sign the informed consent form.
Key Trial Info
Start Date :
June 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06012461
Start Date
June 30 2023
End Date
December 30 2025
Last Update
September 5 2023
Active Locations (1)
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1
National Engineering Research Center of Neuromodulation
Beijing, Beijing Municipality, China, 100084