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 @ 1:06 PM
Ignite Modification Date:
2025-12-24 @ 1:06 PM
NCT ID:
NCT03552861
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years old and ≤ 80 years old, male or female
2. Subjects with idiopathic PD (according to Movement Disorder Society Clinical Diagnostic Criteria，both clinically established PD and clinically probable PD)
3. Subjects fulfilling the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th edition(DSM-IV)
4. Did not use antidepressant(s) for a minimum of 2 months
5. Untreated or had stabilized doses of anti-Parkinson's disease medication for \> 28 days, and maintain this dose during treatment
6. Subjects or their legal representatives could follow the research plan, visit plan
7. Subjects or their legal guardians agree to participate in the trial and signs informed consent
Exclusion Criteria:
1. Subjects with Parkinson's plus syndrome(PPS) or Secondary Parkinson Disease caused by vascular factors, toxins, and drugs
2. Subjects with persistent head tremor
3. Subjects with dementia
4. Subjects with suicidal tendency and psychotic symptoms
5. Subjects with consciousness, history of stroke, severe neurological/psychiatric disorders such as transient ischemic attack within 1 year prior to screening (Visit 1), or other severe organic diseases
6. Accepted deep brain stimulation(DBS) or other invasive brain surgery previously
7. Subjects with contraindications for repetitive transcranial magnetic stimulation(rTMS), such as history of epileptic seizures, pregnant, implantation of pacemaker or other metal implants in the body, intracranial hypertension, severe hemorrhagic tendency, etc.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03552861
Study Brief:
Protocol Section:
NCT03552861