Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT04976569
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of Parkinson's disease: The diagnostic criteria for Parkinson's disease are the Clinical Diagnostic Criteria of UK PD Society Brain Bank Clinical Diagnostic Criteria or 2015 MDS Clinical Diagnostic Criteria for PD.All diagnoses of Parkinson's disease were made by three neurologists who were experienced in the field of movement disorders.
2. Bilateral STN-DBS has been implanted for more than 1 year, and stable drug therapy regimen and parameter program control regimen have been maintained for 6 weeks or more;
3. Patients with onset age of 50 years and above;
4. Do not use phenobarbital, chloral hydrate, benzodiazepines and non-benzodiazepines as sedatives and hypnotics at night.
Exclusion Criteria:
1. Patients who underwent pallidotomy and other brain surgery;
2. Other patients with secondary Parkinson's syndrome and Parkinsonism-plus syndrome;
3. Patients with other central nervous system and peripheral nervous system diseases;
4. Patients complicated with severe medical system diseases, patients with unstable vital signs and unable to tolerate clinical evaluation;
5. Patients with severe mental illness;
6. Use phenobarbital, chloral hydrate, benzodiazepines and non-benzodiazepines as sedatives and hypnotics at night;
7. Patients who cannot complete informed consent due to cognitive and communication barriers, or refuse to sign informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT04976569
Study Brief:
Protocol Section:
NCT04976569