Differences Between Patients With Vascular Parkinsonism and Parkinson's Disease
NCT ID: NCT04308135
Last Updated: 2023-09-21
Study Results
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Basic Information
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COMPLETED
104 participants
OBSERVATIONAL
2019-09-01
2022-04-01
Brief Summary
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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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Detailed Description
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• 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.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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vascular parkinsonism
the investigators will recruit 30 patients diagnosed as Vascular Parkisonism ,
Neuro-radiological tools:
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.
cognitive tests
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
lab investigations
Each patient will undergo full lab investigations:\[lipid profile ,complete blood count, uric acid ,Hemoglobin A1c (HbA1c), liver functions, renal functions, and electrolytes\]
Beck depression inventory (BDI)(Arabic version)
Clinical Tool for depression
Clinical Tools for Urinary symptoms:
the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Scale (Arabic version)
Freezing of gait questionnaire
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.
non-motor symptoms scales (NMSS).
Clinical Tool for assessment of non-motor symptoms of PD
Movement Disorders Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS):
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
ELIZA for alpha-synuclein
measuring serum of alpha-synuclein, tau and their autoantibodoies
transcranial color-coded duplex(TCCD)
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.
extracranial carotid duplex
to assess atherosclerosis, stenosis of carotids
The Arabic version of Parkinson's Disease Questionnaire( PDQ-39)
Clinical tool for quality of life of PD patients
Parkinson's disease
50 patients diagnosed as Parkinson Disease
Neuro-radiological tools:
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.
cognitive tests
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
lab investigations
Each patient will undergo full lab investigations:\[lipid profile ,complete blood count, uric acid ,Hemoglobin A1c (HbA1c), liver functions, renal functions, and electrolytes\]
Beck depression inventory (BDI)(Arabic version)
Clinical Tool for depression
Clinical Tools for Urinary symptoms:
the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Scale (Arabic version)
Freezing of gait questionnaire
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.
non-motor symptoms scales (NMSS).
Clinical Tool for assessment of non-motor symptoms of PD
Movement Disorders Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS):
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
ELIZA for alpha-synuclein
measuring serum of alpha-synuclein, tau and their autoantibodoies
transcranial color-coded duplex(TCCD)
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.
extracranial carotid duplex
to assess atherosclerosis, stenosis of carotids
The Arabic version of Parkinson's Disease Questionnaire( PDQ-39)
Clinical tool for quality of life of PD patients
Controls
30 healthy controls.
cognitive tests
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
Beck depression inventory (BDI)(Arabic version)
Clinical Tool for depression
Clinical Tools for Urinary symptoms:
the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Scale (Arabic version)
Freezing of gait questionnaire
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.
non-motor symptoms scales (NMSS).
Clinical Tool for assessment of non-motor symptoms of PD
Movement Disorders Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS):
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
transcranial color-coded duplex(TCCD)
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.
extracranial carotid duplex
to assess atherosclerosis, stenosis of carotids
The Arabic version of Parkinson's Disease Questionnaire( PDQ-39)
Clinical tool for quality of life of PD patients
Interventions
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Neuro-radiological tools:
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.
cognitive tests
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
lab investigations
Each patient will undergo full lab investigations:\[lipid profile ,complete blood count, uric acid ,Hemoglobin A1c (HbA1c), liver functions, renal functions, and electrolytes\]
Beck depression inventory (BDI)(Arabic version)
Clinical Tool for depression
Clinical Tools for Urinary symptoms:
the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Scale (Arabic version)
Freezing of gait questionnaire
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.
non-motor symptoms scales (NMSS).
Clinical Tool for assessment of non-motor symptoms of PD
Movement Disorders Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS):
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
ELIZA for alpha-synuclein
measuring serum of alpha-synuclein, tau and their autoantibodoies
transcranial color-coded duplex(TCCD)
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.
extracranial carotid duplex
to assess atherosclerosis, stenosis of carotids
The Arabic version of Parkinson's Disease Questionnaire( PDQ-39)
Clinical tool for quality of life of PD patients
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
ALL
Yes
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Ali Shalash
professor of Neurology
Locations
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Ain Shams University
Cairo, , Egypt
Countries
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References
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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.
Other Identifiers
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MD209/2019
Identifier Type: -
Identifier Source: org_study_id
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