Vascular ParkinsonismNCT04308135
Differences Between Patients With Vascular Parkinsonism and Parkinson's Disease
An observational study of Vascular Parkinsonism and Parkinson's Disease, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vascular Parkinsonism, Parkinson's Disease
- What is being tested?
- Neuro-radiological tools:, cognitive tests and lab investigations
- How many people
- 104 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2019to 1 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The investigators will recruit 30 patients diagnosed as VP, 50 patients diagnosed as PD , and 30 healthy age and sex matched controls.
Who may be able to join
- 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:
Show all 11Show fewer
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical and Neuroimaging Differences Between Patients With Vascular Parkinsonism and Idiopathic Parkinson's Disease
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 .
Read the 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
- Being tested
- Neuro-radiological tools:, cognitive tests, lab investigations, Beck depression inventory (BDI)(Arabic version), Clinical Tools for Urinary symptoms:
- Keywords
- Parkinson's Disease, vascular parkinsonism, MRI brain, non-motor
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro-radiological tools:Diagnostic test
Also called magnetic resonance imaging (MRI)
MRI brain: to measure white matter
- 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 testsDiagnostic test
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 investigationsDiagnostic test
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)Diagnostic test
Clinical Tool for depression
Clinical Tools for Urinary symptoms:Diagnostic test
the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Scale (Arabic version)
Freezing of gait questionnaireDiagnostic test
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).Diagnostic test
Clinical Tool for assessment of non-motor symptoms of PD
Movement Disorders Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS):Diagnostic test
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-synucleinDiagnostic test
measuring serum of alpha-synuclein, tau and their autoantibodoies
transcranial color-coded duplex(TCCD)Other
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 duplexOther
to assess atherosclerosis, stenosis of carotids
The Arabic version of Parkinson's Disease Questionnaire( PDQ-39)Other
Clinical tool for quality of life of PD patients
| Study group | Role | What they receive |
|---|---|---|
| vascular parkinsonism | the investigators will recruit 30 patients diagnosed as Vascular Parkisonism , Receives: 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) | |
| Parkinson's disease | 50 patients diagnosed as Parkinson Disease Receives: 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) | |
| Controls | 30 healthy controls. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 2 year ....will be at single point
Secondary outcomes (2)
Substantia nigra Echogenicity by transcranial doppler
to detect differences of substantia nigra Echogenicity by millimeter and differences of mean flow velocities by centimeter per second
Measured: 2 years
Carotid arties wall thickness by Extra cranial duplex
to detect differences of Intima-media thickness values by millimeter and flow velocities by centimeter per second
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start1 Sep 2019
- Primary completion1 Dec 2021
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular ParkinsonismStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Shalash, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308135
- Sponsor's protocol ID
- MD209/2019
- Status last verified
- Sep 2023
- First submitted
- 12 Mar 2020
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38321372
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical and Neuroimaging Differences Between Patients With Vascular Parkinsonism and Idiopathic Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04308135
- Acronym / sponsor ID
- MD209/2019
- Conditions
- Vascular Parkinsonism, Parkinson's Disease
- Keywords
- Parkinson's Disease, vascular parkinsonism, MRI brain, non-motor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| vascular parkinsonism | – | 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)the investigators will recruit 30 patients diagnosed as Vascular Parkisonism , |
| Parkinson's disease | – | 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)50 patients diagnosed as Parkinson Disease |
| Controls | – | 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)30 healthy controls. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators will recruit 30 patients diagnosed as VP, 50 patients diagnosed as PD , and 30 healthy age and sex matched controls.
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (6 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuro-radiological tools:Also: magnetic resonance imaging (MRI)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 | Parkinson's disease, vascular parkinsonism |
| cognitive testsAll 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 | Controls, Parkinson's disease, vascular parkinsonism |
| lab investigationsEach patient will undergo full lab investigations:[lipid profile ,complete blood count, uric acid ,Hemoglobin A1c (HbA1c), liver functions, renal functions, and electrolytes] | Diagnostic test | Parkinson's disease, vascular parkinsonism |
| Beck depression inventory (BDI)(Arabic version)Clinical Tool for depression | Diagnostic test | Controls, Parkinson's disease, vascular parkinsonism |
| Clinical Tools for Urinary symptoms:the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Scale (Arabic version) | Diagnostic test | Controls, Parkinson's disease, vascular parkinsonism |
| Freezing of gait questionnaireClinical 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 | Controls, Parkinson's disease, vascular parkinsonism |
| non-motor symptoms scales (NMSS).Clinical Tool for assessment of non-motor symptoms of PD | Diagnostic test | Controls, Parkinson's disease, vascular parkinsonism |
| 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 | Controls, Parkinson's disease, vascular parkinsonism |
| ELIZA for alpha-synucleinmeasuring serum of alpha-synuclein, tau and their autoantibodoies | Diagnostic test | Parkinson's disease, vascular parkinsonism |
| 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 | Controls, Parkinson's disease, vascular parkinsonism |
| extracranial carotid duplexto assess atherosclerosis, stenosis of carotids | Other | Controls, Parkinson's disease, vascular parkinsonism |
| The Arabic version of Parkinson's Disease Questionnaire( PDQ-39)Clinical tool for quality of life of PD patients | Other | Controls, Parkinson's disease, vascular parkinsonism |
Primary outcome
MDS-UPDRS scale on on and off state
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)
Montreal Cognitive Assessment (MoCA) (Arabic version)
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
White matter severity by MRI brain
Time frame: 2 years....will be at single point
White matter differences by fazekas scale 0,1,2 or 3 scores
Non motor symptoms scale
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
Addenbrooke's test (Arabic version)
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
Wechsler Adult Intelligence Scale (WAIS)
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.
Frontal Assessment Battery scale.
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.
2 secondary outcomes
Substantia nigra Echogenicity by transcranial doppler
Time frame: 2 years
Carotid arties wall thickness by Extra cranial duplex
Time frame: 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Derived from this study: PubMed 38321372George 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Parkinsonism and Parkinson's Disease, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MDS-UPDRS scale on on and off state (time frame: 2 year... will be at single point). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04308135, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.