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 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT04308135
Eligibility Criteria:
Inclusion Criteria:
* Patients diagnosed with PD or VP, and healthy controls will be included in the study.
* PD diagnosis will be based on the Queen Square Brain Bank for Neurological Disorders clinical criteria and MDS criteria.
* The VP patients will be included if they fulfill the following criteria (Zijlman's diagnostic criteria)Parkinsonism presentation (at least two of the cardinal features: tremors, bradykinesia, rigidity and postural instability).
Cerebrovascular disease, defined as evidence of relevant cerebrovascular disease by brain imaging or the presence of focal signs or symptoms consistent with stroke.
A relationship between (1) and (2): acute or delayed progressive onset of parkinsonism.
Based on the above criteria, two forms of VP are suggested: one with acute onset, and another one with insidious progression. The diagnosis will be confirmed by assigning a vascular score. Two points or more are essential to diagnose VP. The points will be assigned as follows:
* Two points: Pathologically or angiographically proven diffuse vascular disease.
* One point: Onset of parkinsonism within 1 month of clinical stroke.
* One point: History of two or more strokes.
* One point: Neuroimaging evidence of vascular disease in two or more vascular territories.
* One point: History of two or more risk factors for stroke (hypertension, smoking, diabetes mellitus, hyperlipidaemia, presence of heart disease associated with stroke \[coronary artery disease, atrial fibrillation, congestive heart failure, valvular heart disease, mitral valve prolapse, and other arrhythmias\], family history of stroke, history of gout, and peripheral vascular disease)
Exclusion Criteria:
* PD patients with age at onset less than 40 years.
* Any alternative cause that significantly impair gait.
* Inability of the patient to undergo neuroimaging.
* Patients couldn't perform the test or severely demented.
* Atypical and other secondary parkinsonism as patients who had a history of toxin exposure.or antipsychotic drugs treatment by history ,neurological examination and brain MRI .
* Family or patient's refusal to give written consent.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT04308135
Study Brief:
Protocol Section:
NCT04308135