Ain Shams University
Cairo, Egypt
NCT Number: NCT04308135
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 .
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Notify Me40 year and older
All sexes
Observational
Cairo, Egypt
Type of Study : case -control comparative study.
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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:
Exclusion criteria
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.
Other names: magnetic resonance imaging (MRI)
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:
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
Time frame: 2 year... will be at single point
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)
Time frame: 2 years....will be at single point
MoCA scores range between 0 and 30. .high score more than or equal 26 is normal
Time frame: 2 years....will be at single point
White matter differences by fazekas scale 0,1,2 or 3 scores
Time frame: 2 years.....will be at single point
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
Time frame: 2 year ....will be at single point
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
Time frame: 2 year....will be at single point
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.
Time frame: 2 year ....will be at single point
Frontal Assessment Battery scale..total score is from a maximum of 18, higher scores indicating better performance.
Time frame: 2 years
to detect differences of substantia nigra Echogenicity by millimeter and differences of mean flow velocities by centimeter per second
Time frame: 2 year
to detect differences of Intima-media thickness values by millimeter and flow velocities by centimeter per second
Ain Shams University
Other
The Clinical and Neuroimaging Differences Between Patients With Vascular Parkinsonism and Idiopathic Parkinson's Disease
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