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Distribution of Non-Motor Symptoms in Idiopathic Parkinson's Disease and Secondary Parkinsonism

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ClinicalTrials.gov Identifier: NCT03432338
Recruitment Status : Completed
First Posted : February 14, 2018
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Örjan Skogar, FUTURUM, Academy of Health and Science

Brief Summary:

BACKGROUND:

Non-Motor Symptoms (NMS) are frequent in patients with Idiopathic Parkinson's Disease (IPD). Clinical expressions, postulated pathophysiological mechanisms and responsiveness to antiparkinson medication represent differences between IPD and secondary Parkinsonism (SP).

OBJECTIVES:

To evaluate NMS expressions in IPD, SP and a control group.

METHODS:

Diagnosis of SP was supported by comorbidity, radiological findings, type of onset, onset rate and progression, exposures for neuroleptics, and responsiveness to pharmacological antiparkinson therapy.

The participants were consecutively recruited at two outdoor patient clinics. The Well-Being Map™ for evaluation. These were completed by the participants at one point before visit. The controls consisted of non-Parkinsonian individuals, matched by age and gender.


Condition or disease Intervention/treatment
Distribution of Non Motor Symptoms in Different Forms of Parkinsonism Other: inquiries

Study Type : Observational
Actual Enrollment : 208 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Distribution of Non-Motor Symptoms in Idiopathic Parkinson's Disease and Secondary Parkinsonism A Controlled, Descriptive Cross-sectional Study Using Parkinson's Well-Being Map™
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
idiopathic parkinson
Classical Parkinson´s disease, idiopathic
Other: inquiries
Inquires reported to clinician.

secondary parkinsonism
parkinsonism due to other reasons than idiopathic
Other: inquiries
Inquires reported to clinician.

controls
persona matched by age and gender, non parkinsonism
Other: inquiries
Inquires reported to clinician.




Primary Outcome Measures :
  1. Prevalence of selfreported motor and non-motor symptoms with The Parkinson´s Well-being map [ Time Frame: 12 months ]

    A graded check list presented in The Parkinson´s Well-BeingMap is used in the registration of self reported frequencies and self experienced strength of Motor and Non- Motor Symptoms in two different forms of parkinsonism and in a group of healthy controls.The experienced magnitude of suffering is visualized in a spider diagram reflecting the strength of each item on an ordinal scale from 0 to four.

    Primary outcome measure is to compare reported frequencies between groups.



Secondary Outcome Measures :
  1. Prevalence of combinations of reported motor and non-motor symptoms using [ Time Frame: 12 months ]
    Secondary outcome measures are to study commonly reported combinations of non-motor symptoms within the groups, with respect to gender and duration of disease.



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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants diagnosed with IPD or SP were recruited from routine care visits at outpatient departments at two medium-sized county hospitals in southern Sweden.
Criteria

Inclusion Criteria:

" Clinical diagnosis of Idiopathic Parkinson´s Disease " Clinical diagnosos of secondary parkinsonism " Healthy controls " Age >65 years " >1 year duration of disease after diagnose

Exclusion Criteria:

" Participation in other studies " Severe disease of psychiatric origin " Severe cognitive impairment


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432338


Sponsors and Collaborators
Örjan Skogar
Investigators
Study Director: Boel Andersson Gäre, PhD FUTURUM, Academy of Health and Science

Responsible Party: Örjan Skogar, MD,PhD, FUTURUM, Academy of Health and Science
ClinicalTrials.gov Identifier: NCT03432338     History of Changes
Other Study ID Numbers: Dnr 2016/118-31
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Parkinson Disease, Secondary
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases