Determining Clinical Profile of Parkinson's Disease Among Egyptian Population
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ClinicalTrials.gov Identifier: NCT02785510
Recruitment Status : Unknown
Verified October 2017 by Ahmed Negida, Zagazig University. Recruitment status was: Recruiting
Parkinson's disease is the second most common neurodegenerative disease affecting about 1-3% of population above 60 years. Recently, non-motor symptoms are getting more attention in PD management. The pattern of PD onset and clinical course differ from one population to another. Many studies have been conducted to determine the clinical profile of PD in populations worldwide. However, no similar studies have been conducted in Egypt. Therefore, the investigators will conduct a nation-wide, collaborative, cross sectional study to determine the pattern of Parkinson's disease onset, clinical course, and non-motor symptoms among Egyptian population.
Duration, in years, from appearance of initial symptom to receiving Parkinson's disease diagnosis.
Initial motor symptom [ Time Frame: At enrolment ]
Number of patients with each initial motor symptom (tremor, rigidity, or bradykinesia).
Side of initial motor symptoms [ Time Frame: At enrolment ]
Number of patients with either right or left side initial motor symptoms.
Clinical subtype of the disease [ Time Frame: At enrolment ]
Number patients with each disease subtype (tremor dominant Parkinson's disease, hypokinetic-rigid dominant Parkinson's disease, or postural instability and gait disturbance dominant Parkinson's disease).
Duration of levodopa treatment from disease onset [ Time Frame: At enrolment ]
Number of years on levodopa treatment since receiving parkinson's disease diagnosis
Levodopa equivalent dose [ Time Frame: At enrolment ]
Current dose of levodopa per day
Non-motor symptoms [ Time Frame: At enrolment ]
Non-motor symptoms measured by the non-motor symptoms questionnaire (NMS)
Quality of life [ Time Frame: At enrolment ]
Mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort assessed by the parkinson's disease quality of life questionnaire (PDQ-39).
Secondary Outcome Measures :
Stage of the disease [optional] [ Time Frame: At enrolment ]
The stage of the disease (stage 1, stage 2, stage 3, or stage 4) according to Hoehn and Yahr classification.
Motor Functions [optional] [ Time Frame: At enrolment ]
Motor functions assessed by the third part of the unified parkinson's disease rating scale (UPDRS III).
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Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients who meet the diagnosis of Parkinson's disease according to the Parkinson's disease criteria of United Kingdom Brain Bank.
Patients who meet the Parkinson's disease criteria of United Kingdom Brain Bank within the study centres.
Patients with vascular Parkinsonism (history of stroke)
Patients with treatment induced Parkinsonism
Patients with history of dopaminergic neurotoxin (1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine)
Ahmed Negida, (1) Principal Investigator; (2) Head of Scientific Committee, Student Research Unit, Zagazig University; and (3) Head of Scientific Committee, Egyptian National Research Collaborative., Zagazig University
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
All data will be collected on a secure database (REDCap of Al-Azhar University). Investigators, who want to share a part of the whole of the patient data, should submit a request to our website (http://emra-collaborative.org/contact.html). They will enter in a data sharing agreement with the Egyptian National Research Collaborative to ensure proper acknowledgement of all study collaborators as non-author contributors in secondary publications from these data.
Additional relevant MeSH terms:
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Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases