Differences Between Patients With Vascular Parkinsonism and Parkinson's Disease
The Clinical and Neuroimaging Differences Between Patients With Vascular Parkinsonism and Idiopathic Parkinson's Disease
1 other identifier
observational
104
1 country
1
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2019
CompletedFirst Submitted
Initial submission to the registry
March 12, 2020
CompletedFirst Posted
Study publicly available on registry
March 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedSeptember 21, 2023
September 1, 2023
2.3 years
March 12, 2020
September 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
MDS-UPDRS scale on on and off state
It detects the motor differences between Vascular Parkinsonism and Parkinson's Disease by scores on the scale ...the maxium score is 199 represents the worst (total disability) with a score of zero representing (no disability)
2 year... will be at single point
Montreal Cognitive Assessment (MoCA) (Arabic version)
MoCA scores range between 0 and 30. .high score more than or equal 26 is normal
2 years....will be at single point
White matter severity by MRI brain
White matter differences by fazekas scale 0,1,2 or 3 scores
2 years....will be at single point
Non motor symptoms scale
It detects the non motor symptoms differences between Vascular Parkinsonism and Parkinson's Disease byUsing a distribution of NMSS scores by quartiles, a classification based on levels from 0 (no NMS at all) to 4 (very severe NMS) for 30 itemes ...high score is worst
2 years.....will be at single point
Addenbrooke's test (Arabic version)
for aassement of Visuospatial skills, Language and verbal fluency result score 16 for visuospatial processing ,26 for language 14 for fluency high score is best
2 year ....will be at single point
Wechsler Adult Intelligence Scale (WAIS)
The average score for the test is 100, and any score from 90 to 109 is considered to be in the average intelligence range. Score from 110 to 119 are considered to be High Average. Superior scores range from 120 to 129 and anything over 130 is considered Very Superior.
2 year....will be at single point
Frontal Assessment Battery scale.
Frontal Assessment Battery scale..total score is from a maximum of 18, higher scores indicating better performance.
2 year ....will be at single point
Secondary Outcomes (2)
Substantia nigra Echogenicity by transcranial doppler
2 years
Carotid arties wall thickness by Extra cranial duplex
2 year
Study Arms (3)
vascular parkinsonism
the investigators will recruit 30 patients diagnosed as Vascular Parkisonism ,
Parkinson's disease
50 patients diagnosed as Parkinson Disease
Controls
30 healthy controls.
Interventions
MRI brain: to measure white matter c) Ultrasonographic examination of extracranial vessels: The intimal medial thickness of the common carotid artery (CCA-IMT) will be measured in B-mode. The carotid arteries will be evaluated for the presence of atherosclerotic lesions (plaques) either soft or hard .The residual lumen and degree of stenosis will be measured. The peak systolic velocity will be detected.
All patients will be evaluated for global cognitive assessment by: Montreal Cognitive Assessment (MoCA) (Arabic version) Visuospatial skills will be assessed by Clock Drawing Tests from MoCA test and copy the intersecting pentagons from Addenbrooke's test (Arabic version) Language will be examined by semantic fluency from Addenbrooke's test (Arabic version) and similarities from Wechsler Adult Intelligence Scale (WAIS) Attention will be evaluated by digit span from Wechsler test),and by the number of seconds needed to sequence numbers using a pencil (Trail making test A) from MoCA test . For the evaluation of memory, participants will complete Wechsler memory subset , and the investigators also will use their three-item recall from the Mini-Mental State Examination( MMSE). Executive functions will be measured by Wisconsin card sorting test and also verbal fluency test from Addenbrooke's test. Frontal Assessment Battery (FAB) scale
Each patient will undergo full lab investigations:\[lipid profile ,complete blood count, uric acid ,Hemoglobin A1c (HbA1c), liver functions, renal functions, and electrolytes\]
Clinical Tool for depression
the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Scale (Arabic version)
Clinical Tools for Gait (in on and off state ), Gait will be assessed by: * .Freezing of gait questionnaire * Berg balance scale. * 10 meter walk test . * Timed up and go test.
Clinical Tool for assessment of non-motor symptoms of PD
Clinical Tools for assessment of the neurological severity and stage of disease Clinical Tool for assessment of the neurological severity and stage of disease during "OFF" and "ON" states, Hoehn and Yahr scale. The presence of lower limb parkinsonism will be determined by a two-point difference between upper limb and lower limb scores of bradykinesia, rigidity or postural instability from part III of the MDS-UPDRS. Patients will be examined in the early morning, in 'OFF' state, with MDS-UPDRS, Hoehn and Yahr and freezing of gait questionnaire(FOG-Q) scales. Immediately afterwards, they will take their regular first dose of levodopa. After 1 hour, patients will be examined again with the same tests and scales. Response to levodopa will be determined as patients who reached a percentage reduction exceeding 25% in part III of the MDS-UPDRS
measuring serum of alpha-synuclein, tau and their autoantibodoies
TCCD using phase array 2.4 Hz probe for evaluation of cerebral vasomotor reactivity (CVR) by measuring the Breath holding index(BHI),flow velocities and pulsatility index of middle cerebral artery and posterior cerebral artery on both sides.
to assess atherosclerosis, stenosis of carotids
Clinical tool for quality of life of PD patients
Eligibility Criteria
The investigators will recruit 30 patients diagnosed as VP, 50 patients diagnosed as PD , and 30 healthy age and sex matched controls.
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University
Cairo, Egypt
Related Publications (1)
George P, Roushdy T, Fathy M, Hamid E, Ibrahim YA, El-Belkimy M, Abdulghani MO, Shalash A. The clinical and neuroimaging differences between vascular parkinsonism and Parkinson's disease: a case-control study. BMC Neurol. 2024 Feb 6;24(1):56. doi: 10.1186/s12883-024-03556-9.
PMID: 38321372DERIVED
Biospecimen
blood samples for biomarkers
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor of Neurology
Study Record Dates
First Submitted
March 12, 2020
First Posted
March 13, 2020
Study Start
September 1, 2019
Primary Completion
December 1, 2021
Study Completion
April 1, 2022
Last Updated
September 21, 2023
Record last verified: 2023-09