Clinical trial NCT04308135: Differences Between Patients With Vascular Parkinsonism and Parkinson's Disease
Official title: The Clinical and Neuroimaging Differences Between Patients With Vascular Parkinsonism and Idiopathic Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Parkinsonism
Parkinson's Disease
Keywords: Parkinson's Disease
vascular parkinsonism
MRI brain
non-motor
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 104
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators will recruit 30 patients diagnosed as VP, 50 patients diagnosed as PD

, and 30 healthy age and sex matched controls.

Brief summary: Vascular parkinsonism (VP) is defined as the presence of parkinsonian syndrome, evidence of cerebrovascular disease by brain imaging and an established relationship between the two disorders.

However, the diagnosis of VP is problematic. This study aims to distinguish VP from Parkinson's disease (PD) in multiple aspects including clinical features as motor ,non motor symptoms

,response to treatment ,cognitive assessments by using multiple scales, neuro-radiological features of magnetic resonance imaging (MRI) and transcranial color-coded duplex (TCCD) findings. This differentiation will have therapeutic and prognostic implications .

Detailed description: Type of Study : case -control comparative study.

• Study Setting: Patients with VP and patients with PD from movement disorders and stroke outpatient clinics in Ain shams University Hospitals.

Sampling Method study of consecutive patients in Ain Shams University clinic, who had been regularly followed up in the clinic and already had a diagnosis either VP or PD at the time of data collection.

Sample Size: 30 patients diagnosed as VP, 50 patients diagnosed as PD, and 30 healthy age and sex matched controls. The difference in selected quantitative variables used to evaluate the participants is used to estimate the sample size.

This study aims to distinguish VP from Parkinson's disease(PD) in multiple aspects including clinical features as motor ,non-motor symptoms, response to treatment ,cognitive assessments by using multiple scales, neuro-radiological features of magnetic resonance imaging (MRI) and transcranial color-coded duplex(TCCD)findings.

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.

Primary outcomes:
measure: MDS-UPDRS scale on on and off state
timeFrame: 2 year... will be at single point
measure: Montreal Cognitive Assessment (MoCA) (Arabic version)
timeFrame: 2 years....will be at single point
measure: White matter severity by MRI brain
timeFrame: 2 years....will be at single point
measure: Non motor symptoms scale
timeFrame: 2 years.....will be at single point
measure: Addenbrooke's test (Arabic version)
timeFrame: 2 year ....will be at single point
measure: Wechsler Adult Intelligence Scale (WAIS)
timeFrame: 2 year....will be at single point
measure: Frontal Assessment Battery scale.
timeFrame: 2 year ....will be at single point
Secondary outcomes:
measure: Substantia nigra Echogenicity by transcranial doppler
timeFrame: 2 years
measure: Carotid arties wall thickness by Extra cranial duplex
timeFrame: 2 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References: