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Closed-loop DBS in Parkinson's Disease

Closed-loop DBS in Parkinson's Disease

Recruiting
18-70 years
All
Phase N/A

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Overview

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

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 details
    Parkinson Disease

NCT06012461

Tsinghua University

26 January 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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