Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT04308135
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2020-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Differences Between Patients With Vascular Parkinsonism and Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood samples for biomarkers'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-18', 'studyFirstSubmitDate': '2020-03-12', 'studyFirstSubmitQcDate': '2020-03-12', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MDS-UPDRS scale on on and off state', 'timeFrame': '2 year... will be at single point', 'description': "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)"}, {'measure': 'Montreal Cognitive Assessment (MoCA) (Arabic version)', 'timeFrame': '2 years....will be at single point', 'description': 'MoCA scores range between 0 and 30. .high score more than or equal 26 is normal'}, {'measure': 'White matter severity by MRI brain', 'timeFrame': '2 years....will be at single point', 'description': 'White matter differences by fazekas scale 0,1,2 or 3 scores'}, {'measure': 'Non motor symptoms scale', 'timeFrame': '2 years.....will be at single point', 'description': "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"}, {'measure': "Addenbrooke's test (Arabic version)", 'timeFrame': '2 year ....will be at single point', 'description': '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'}, {'measure': 'Wechsler Adult Intelligence Scale (WAIS)', 'timeFrame': '2 year....will be at single point', 'description': '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.'}, {'measure': 'Frontal Assessment Battery scale.', 'timeFrame': '2 year ....will be at single point', 'description': 'Frontal Assessment Battery scale..total score is from a maximum of 18, higher scores indicating better performance.'}], 'secondaryOutcomes': [{'measure': 'Substantia nigra Echogenicity by transcranial doppler', 'timeFrame': '2 years', 'description': 'to detect differences of substantia nigra Echogenicity by millimeter and differences of mean flow velocities by centimeter per second'}, {'measure': 'Carotid arties wall thickness by Extra cranial duplex', 'timeFrame': '2 year', 'description': 'to detect differences of Intima-media thickness values by millimeter and flow velocities by centimeter per second'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Parkinson's Disease", 'vascular parkinsonism', 'MRI brain', 'non-motor'], 'conditions': ['Vascular Parkinsonism', "Parkinson's Disease"]}, 'referencesModule': {'references': [{'pmid': '38321372', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': "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.\n\nHowever, 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\n\n,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 .", 'detailedDescription': "Type of Study : case -control comparative study.\n\n• Study Setting: Patients with VP and patients with PD from movement disorders and stroke outpatient clinics in Ain shams University Hospitals.\n\nSampling 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.\n\nSample 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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The investigators will recruit 30 patients diagnosed as VP, 50 patients diagnosed as PD\n\n, and 30 healthy age and sex matched controls.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients diagnosed with PD or VP, and healthy controls will be included in the study.\n* PD diagnosis will be based on the Queen Square Brain Bank for Neurological Disorders clinical criteria and MDS criteria.\n* 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).\n\nCerebrovascular disease, defined as evidence of relevant cerebrovascular disease by brain imaging or the presence of focal signs or symptoms consistent with stroke.\n\nA relationship between (1) and (2): acute or delayed progressive onset of parkinsonism.\n\nBased 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:\n\n* Two points: Pathologically or angiographically proven diffuse vascular disease.\n* One point: Onset of parkinsonism within 1 month of clinical stroke.\n* One point: History of two or more strokes.\n* One point: Neuroimaging evidence of vascular disease in two or more vascular territories.\n* 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)\n\nExclusion Criteria:\n\n* PD patients with age at onset less than 40 years.\n* Any alternative cause that significantly impair gait.\n* Inability of the patient to undergo neuroimaging.\n* Patients couldn't perform the test or severely demented.\n* 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 .\n* Family or patient's refusal to give written consent."}, 'identificationModule': {'nctId': 'NCT04308135', 'briefTitle': "Differences Between Patients With Vascular Parkinsonism and Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': "The Clinical and Neuroimaging Differences Between Patients With Vascular Parkinsonism and Idiopathic Parkinson's Disease", 'orgStudyIdInfo': {'id': 'MD209/2019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'vascular parkinsonism', 'description': 'the investigators will recruit 30 patients diagnosed as Vascular Parkisonism ,', 'interventionNames': ['Diagnostic Test: Neuro-radiological tools:', 'Diagnostic Test: cognitive tests', 'Diagnostic Test: lab investigations', 'Diagnostic Test: Beck depression inventory (BDI)(Arabic version)', 'Diagnostic Test: Clinical Tools for Urinary symptoms:', 'Diagnostic Test: Freezing of gait questionnaire', 'Diagnostic Test: non-motor symptoms scales (NMSS).', "Diagnostic Test: Movement Disorders Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS):", 'Diagnostic Test: ELIZA for alpha-synuclein', 'Other: transcranial color-coded duplex(TCCD)', 'Other: extracranial carotid duplex', "Other: The Arabic version of Parkinson's Disease Questionnaire( PDQ-39)"]}, {'label': "Parkinson's disease", 'description': '50 patients diagnosed as Parkinson Disease', 'interventionNames': ['Diagnostic Test: Neuro-radiological tools:', 'Diagnostic Test: cognitive tests', 'Diagnostic Test: lab investigations', 'Diagnostic Test: Beck depression inventory (BDI)(Arabic version)', 'Diagnostic Test: Clinical Tools for Urinary symptoms:', 'Diagnostic Test: Freezing of gait questionnaire', 'Diagnostic Test: non-motor symptoms scales (NMSS).', "Diagnostic Test: Movement Disorders Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS):", 'Diagnostic Test: ELIZA for alpha-synuclein', 'Other: transcranial color-coded duplex(TCCD)', 'Other: extracranial carotid duplex', "Other: The Arabic version of Parkinson's Disease Questionnaire( PDQ-39)"]}, {'label': 'Controls', 'description': '30 healthy controls.', 'interventionNames': ['Diagnostic Test: cognitive tests', 'Diagnostic Test: Beck depression inventory (BDI)(Arabic version)', 'Diagnostic Test: Clinical Tools for Urinary symptoms:', 'Diagnostic Test: Freezing of gait questionnaire', 'Diagnostic Test: non-motor symptoms scales (NMSS).', "Diagnostic Test: Movement Disorders Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS):", 'Other: transcranial color-coded duplex(TCCD)', 'Other: extracranial carotid duplex', "Other: The Arabic version of Parkinson's Disease Questionnaire( PDQ-39)"]}], 'interventions': [{'name': 'Neuro-radiological tools:', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['magnetic resonance imaging (MRI)'], 'description': 'MRI brain: to measure white matter\n\nc) 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.', 'armGroupLabels': ["Parkinson's disease", 'vascular parkinsonism']}, {'name': 'cognitive tests', 'type': 'DIAGNOSTIC_TEST', 'description': "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\n\n, 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", 'armGroupLabels': ['Controls', "Parkinson's disease", 'vascular parkinsonism']}, {'name': 'lab investigations', 'type': 'DIAGNOSTIC_TEST', 'description': 'Each patient will undergo full lab investigations:\\[lipid profile ,complete blood count, uric acid ,Hemoglobin A1c (HbA1c), liver functions, renal functions, and electrolytes\\]', 'armGroupLabels': ["Parkinson's disease", 'vascular parkinsonism']}, {'name': 'Beck depression inventory (BDI)(Arabic version)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Clinical Tool for depression', 'armGroupLabels': ['Controls', "Parkinson's disease", 'vascular parkinsonism']}, {'name': 'Clinical Tools for Urinary symptoms:', 'type': 'DIAGNOSTIC_TEST', 'description': 'the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Scale (Arabic version)', 'armGroupLabels': ['Controls', "Parkinson's disease", 'vascular parkinsonism']}, {'name': 'Freezing of gait questionnaire', 'type': 'DIAGNOSTIC_TEST', 'description': 'Clinical Tools for Gait (in on and off state ), Gait will be assessed by:\n\n* .Freezing of gait questionnaire\n* Berg balance scale.\n* 10 meter walk test .\n* Timed up and go test.', 'armGroupLabels': ['Controls', "Parkinson's disease", 'vascular parkinsonism']}, {'name': 'non-motor symptoms scales (NMSS).', 'type': 'DIAGNOSTIC_TEST', 'description': 'Clinical Tool for assessment of non-motor symptoms of PD', 'armGroupLabels': ['Controls', "Parkinson's disease", 'vascular parkinsonism']}, {'name': "Movement Disorders Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS):", 'type': 'DIAGNOSTIC_TEST', 'description': '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.\n\nResponse to levodopa will be determined as patients who reached a percentage reduction exceeding 25% in part III of the MDS-UPDRS', 'armGroupLabels': ['Controls', "Parkinson's disease", 'vascular parkinsonism']}, {'name': 'ELIZA for alpha-synuclein', 'type': 'DIAGNOSTIC_TEST', 'description': 'measuring serum of alpha-synuclein, tau and their autoantibodoies', 'armGroupLabels': ["Parkinson's disease", 'vascular parkinsonism']}, {'name': 'transcranial color-coded duplex(TCCD)', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Controls', "Parkinson's disease", 'vascular parkinsonism']}, {'name': 'extracranial carotid duplex', 'type': 'OTHER', 'description': 'to assess atherosclerosis, stenosis of carotids', 'armGroupLabels': ['Controls', "Parkinson's disease", 'vascular parkinsonism']}, {'name': "The Arabic version of Parkinson's Disease Questionnaire( PDQ-39)", 'type': 'OTHER', 'description': 'Clinical tool for quality of life of PD patients', 'armGroupLabels': ['Controls', "Parkinson's disease", 'vascular parkinsonism']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor of Neurology', 'investigatorFullName': 'Ali Shalash', 'investigatorAffiliation': 'Ain Shams University'}}}}