Validation of a Non-Motor Fluctuation Assessment Instrument (NoMoFA) for Parkinson's Disease

Investigators have developed a comprehensive questionnaire that assesses the presence of non-motor fluctuations (NMFs) in individuals with Parkinson's disease (PD). To date, 189 participants with PD have been assessed for preliminary data analysis prior to developing the penultimate version. At this time the objectives are to: (i) assess the scale's internal consistency and item-to-total correlations; (ii) assess test-retest reliability; (iii) use factor analysis and reliability measures to guide item reduction; (iv) assess construct validity; and (v) assess the scales ability to discriminate between static non-motor symptoms and non-motor symptoms which fluctuate (vi) estimate the relative distribution of cognitive, psychiatric, autonomic, sleep and sensory NMFs in PD patients with motor fluctuations and their impact on quality of life in Parkinson's disease.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease

• Study Type: Observational
• Enrollment (Actual): 202

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M6A 2E1
      • Assistive Technology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals, both men and women, who have been diagnosed with idiopathic Parkinson's Disease and have motor and non-motor fluctuating symptoms are invited to participate in the study. To ensure a representative sample, subjects spanning the disease spectrum will be equally represented in terms of mild, moderate and advanced symptoms of PD.

Description

Inclusion Criteria:

• Diagnosed with Idiopathic Parkinson's Disease (according to the United Kingdom Parkinson's Disease Society Brain Bank clinical diagnostic criteria)
• Stage of symptoms is mild, moderate or severe as per the Hoehn & Yahr scale
• Have motor fluctuations
• Have non-motor fluctuations

Exclusion Criteria:

• Atypical Parkinsonism
• Lack of motor fluctuations
• Lack of English language proficiency in either subject or caregiver

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cronbach's Alpha	alpha 0 - 1.0	Baseline
Item-to-total correlation	correlation -1.0 - 1.0	Baseline
Inter-rater reliability	kappa 0 - 1.0	1 week after Baseline
Concurrent validity	correlation -1.0 - 1.0	Baseline

Collaborators and Investigators

• Sponsor: Assistive Technology Clinic, Canada
• Collaborators: University Health Network, Toronto; University of Michigan; The Cleveland Clinic; University of Cincinnati; Rush University; The Parkinson Study Group
• Investigators: Principal Investigator: Galit Kleiner, MD, Assistive Technology Clinic

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 13, 2018
• Primary Completion (ACTUAL): September 11, 2019
• Study Completion (ACTUAL): September 11, 2019

Study Registration Dates

• First Submitted: February 7, 2019
• First Submitted That Met QC Criteria: February 15, 2019
• First Posted (ACTUAL): February 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Non-motor fluctuation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 10-27

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No