NCT04308135

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 104 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vascular Parkinsonism
• Parkinson's Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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
DIAGNOSTIC_TEST	lab investigations	Each patient will undergo full lab investigations:\[lipid profile ,complete blood count, uric acid ,Hemoglobin A1c (HbA1c), liver functions, renal functions, and electrolytes\]
DIAGNOSTIC_TEST	Beck depression inventory (BDI)(Arabic version)	Clinical Tool for depression
DIAGNOSTIC_TEST	Clinical Tools for Urinary symptoms:	the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Scale (Arabic version)
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	non-motor symptoms scales (NMSS).	Clinical Tool for assessment of non-motor symptoms of PD
DIAGNOSTIC_TEST	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
DIAGNOSTIC_TEST	ELIZA for alpha-synuclein	measuring serum of alpha-synuclein, tau and their autoantibodoies
OTHER	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.
OTHER	extracranial carotid duplex	to assess atherosclerosis, stenosis of carotids
OTHER	The Arabic version of Parkinson's Disease Questionnaire( PDQ-39)	Clinical tool for quality of life of PD patients

Timeline

• Start date: 2019-09-01
• Primary completion: 2021-12-01
• Completion: 2022-04-01
• First posted: 2020-03-13
• Last updated: 2023-09-21

Locations

1 site across 1 country: Egypt