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

• ClinicalTrials.gov Identifier: NCT03432338
• Recruitment Status: Completed
• First Posted: February 14, 2018
• Last Update Posted: February 14, 2018
• Sponsor: Örjan Skogar
• Information provided by (Responsible Party): Örjan Skogar, Region Jönköping County

Study Description

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 Design

• 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

Groups and Cohorts

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Sponsors and Collaborators

Örjan Skogar

Investigators

• Study Director: Boel Andersson Gäre, PhD; Region Jönköping County

More Information

• Responsible Party: Örjan Skogar, MD,PhD, Region Jönköping County
• ClinicalTrials.gov Identifier: NCT03432338 History of Changes
• Other Study ID Numbers: Dnr 2016/118-31
• First Posted: February 14, 2018
• 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