Differences Between Patients With Vascular Parkinsonism and Parkinson's Disease

Ain Shams University

Status: Completed

Conditions: Vascular Parkinsonism; Parkinson's Disease

Treatments: Diagnostic Test: cognitive tests; Diagnostic Test: Freezing of gait questionnaire; Other: extracranial carotid duplex; Diagnostic Test: Beck depression inventory (BDI)(Arabic version); Diagnostic Test: ELIZA for alpha-synuclein; Other: The Arabic version of Parkinson's Disease Questionnaire( PDQ-39); Diagnostic Test: lab investigations; Diagnostic Test: Movement Disorders Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS):; Diagnostic Test: Clinical Tools for Urinary symptoms:; Diagnostic Test: Neuro-radiological tools:; Diagnostic Test: non-motor symptoms scales (NMSS).; Other: transcranial color-coded duplex(TCCD)

Study type: Observational

Funder types: Other

Identifiers

NCT04308135

MD209/2019

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

104 participants in 3 patient groups

vascular parkinsonism

Description:

the investigators will recruit 30 patients diagnosed as Vascular Parkisonism ,

Treatment:

Diagnostic Test: Freezing of gait questionnaire

Other: transcranial color-coded duplex(TCCD)

Diagnostic Test: non-motor symptoms scales (NMSS).

Diagnostic Test: Movement Disorders Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS):

Diagnostic Test: Clinical Tools for Urinary symptoms:

Other: extracranial carotid duplex

Diagnostic Test: lab investigations

Diagnostic Test: Neuro-radiological tools:

Diagnostic Test: cognitive tests

Other: The Arabic version of Parkinson's Disease Questionnaire( PDQ-39)

Diagnostic Test: ELIZA for alpha-synuclein

Diagnostic Test: Beck depression inventory (BDI)(Arabic version)

Parkinson's disease

Description:

50 patients diagnosed as Parkinson Disease

Treatment:

Diagnostic Test: Freezing of gait questionnaire

Other: transcranial color-coded duplex(TCCD)

Diagnostic Test: non-motor symptoms scales (NMSS).

Diagnostic Test: Movement Disorders Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS):

Diagnostic Test: Clinical Tools for Urinary symptoms:

Other: extracranial carotid duplex

Diagnostic Test: lab investigations

Diagnostic Test: Neuro-radiological tools:

Diagnostic Test: cognitive tests

Other: The Arabic version of Parkinson's Disease Questionnaire( PDQ-39)

Diagnostic Test: ELIZA for alpha-synuclein

Diagnostic Test: Beck depression inventory (BDI)(Arabic version)

Controls

Description:

30 healthy controls.

Treatment:

Diagnostic Test: Freezing of gait questionnaire

Other: transcranial color-coded duplex(TCCD)

Diagnostic Test: non-motor symptoms scales (NMSS).

Diagnostic Test: Movement Disorders Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS):

Diagnostic Test: Clinical Tools for Urinary symptoms:

Other: extracranial carotid duplex

Diagnostic Test: cognitive tests

Other: The Arabic version of Parkinson's Disease Questionnaire( PDQ-39)

Diagnostic Test: Beck depression inventory (BDI)(Arabic version)