Parkinson DiseaseNCT03845634
Validation of a Non-Motor Fluctuation Assessment Instrument (NoMoFA) for Parkinson's Disease
An observational study of Parkinson Disease, run by Assistive Technology Clinic, Canada at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- How many people
- 202 participants
- Where
- 1 siteCanada
- Study dates
- 13 Sep 2018to 11 Sep 2019
- 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 Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Atypical Parkinsonism
- Lack of motor fluctuations
- Lack of English language proficiency in either subject or caregiver
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Parkinson Disease
- Keywords
- Non-motor fluctuation
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Cronbach's Alpha
alpha 0 - 1.0
Measured: Baseline
Item-to-total correlation
correlation -1.0 - 1.0
Measured: Baseline
Inter-rater reliability
kappa 0 - 1.0
Measured: 1 week after Baseline
Concurrent validity
correlation -1.0 - 1.0
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start13 Sep 2018
- Primary completion11 Sep 2019
- Study completion11 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistive Technology Clinic, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cincinnati, The Cleveland Clinic, University Health Network, Toronto, University of Michigan, Rush University, The Parkinson Study Group
- Responsible party
- Sponsor
- Investigators
- Galit Kleiner, MD, Principal investigator, Assistive Technology Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845634
- Sponsor's protocol ID
- 10-27
- Status last verified
- Jul 2020
- First submitted
- 7 Feb 2019
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Non-Motor Fluctuation Assessment Instrument (NoMoFA) for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03845634
- Acronym / sponsor ID
- 10-27
- Conditions
- Parkinson Disease
- Keywords
- Non-motor fluctuation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Assistive Technology Clinic, CanadaUniversity, hospital or other
- Collaborators
- University of Cincinnati, The Cleveland Clinic, University Health Network, Toronto, University of Michigan, Rush University, The Parkinson Study Group
- Study start
- 13 Sep 2018 (actual)
- Primary completion
- 11 Sep 2019 (actual)
- Study completion
- 11 Sep 2019 (actual)
- First posted
- 19 Feb 2019 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Atypical Parkinsonism
- Lack of motor fluctuations
- Lack of English language proficiency in either subject or caregiver
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cronbach's Alpha
Time frame: Baseline
alpha 0 - 1.0
Item-to-total correlation
Time frame: Baseline
correlation -1.0 - 1.0
Inter-rater reliability
Time frame: 1 week after Baseline
kappa 0 - 1.0
Concurrent validity
Time frame: Baseline
correlation -1.0 - 1.0
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 8 Jul 2020.
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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.
Galit Kleiner, MD principal investigator
Assistive Technology Clinic
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 Parkinson Disease, run by Assistive Technology Clinic, Canada at 1 site in Canada.
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 4 inclusion and 3 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 8 Jul 2020. 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 Canada. 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?
Cronbach's Alpha (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2020.