Parkinson DiseaseNCT03432338
Distribution of Non-Motor Symptoms in Idiopathic Parkinson's Disease and Secondary Parkinsonism
An observational study of Parkinson Disease, run by Örjan Skogar.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- inquiries
- How many people
- 208 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Jul 2017
- 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 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
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.
Who may be able to join
- " Clinical diagnosis of Idiopathic Parkinson´s Disease " Clinical diagnosos of secondary parkinsonism " Healthy controls " Age >65 years " >1 year duration of disease after diagnose
Who cannot join
- " Participation in other studies " Severe disease of psychiatric origin " Severe cognitive impairment
About this study
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™
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).
Read more
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.
Read the detailed description
Over the past decades knowledge of the natural history and progression of Parkinson´s disease (PD) has increased. Age at onset, time to troublesome complications are well described. Parallell to this, the society has been more and more aware of differences between gender in the expressions of diseases. Differences in self reported experiences are of great interest as this is tightly interconnected with Health Related Quality of Life, (HRQoL).
The incidence of PD rapidly increase over the age of 60 years (y) , with only 4% of the cases being under the age of 50 y. The rate for men 19.0 per 100,000, was 91% higher than that for women (9.9 per 100,000 )The age- and gender-adjusted rate per 100,000 was highest among Hispanics (16.6,non-Hispanic Whites ,Asians (11.3, and Blacks (10.2). These data suggest that the incidence of Parkinson's disease varies by race/ethnicity.
( ref. Van den Eeden 2003)
Nonmotor Symptoms in Parkinson's Disease:
Of the nine domains in the validated NMSS (Chaudhuri, Martinez- Martin, Brown, et al., 2007), sexual dysfunction and mood changes have been commonly observed to have associations with specific gender. While sexual dysfunction has been commonly reported with a significantly higher proportion among men (Kova ́cs, Makkos, Aschermann, et al., 2016; Martinez-Martin, Falup Pecurariu, Odin, et al., 2012; Picillo, Amboni, Erro, et al., 2013; Solla, Cannas, Ibba, et al., 2012; Szewczyk- Krolikowski, Tomlinson, Nithi, et al., 2014), mood symptoms, which encompass loss of interest in surroundings, lack of motivation, feeling ner- vous, flat mood, and difficulty in experiencing pleasure, have been frequently reported among women in a higher proportion compared to men with PD (Guo, Song, Chen, et al., 2013; Martinez-Martin et al., 2012; Nicoletti, Vasta, Mostile, et al., 2017; Solla et al., 2012; Song, Gu, An, \& Chan, 2014).
It is well known that in the general population ( not specific parkinsonism ) in industrialized societies men die earlier than women but that women have poorer health than men. Differences discussed are differences in biological risks and acquired risks . But studies have revealed that the variations in health experiences depend on the particular symptom or condition in question and also according to the phase of the life cycle.
Already In an article by S.Macintyre et al from 1996 two large British surveys were examined and revealed a larger complexity than earlier studies had shown in the description of health surveys and differences between gender. These often described the consistency of reporting more illness , poorer self-evaluation of health and higher rates of psychosocial malaise in women than in men.
In this study more complex patterns of sex differences were shown for different symptoms reported. 'Worrying', 'nerves', 'always tired', 'headaches', 'constipation' and 'fainting or dizziness' showed the most consistent female excess. Sickness, nausea or stomach trouble were only dominating among 18 year old females and 'trouble with eyes' among 56-60 year olds in another large survey. In contrast, two symptoms, 'palpitations' and 'trouble with ears' show a male excess among middle aged. Female excess was only consistently found across the life span for the more psychological manifestations of distress, and was far less apparent for a number of physical symptoms and conditions.
Problems relating to reproduction will naturally show a female excess in the childbearing years, hormonal differences are apparent before and after the menopause.
Probably an oversimplification have been the fact in older sociological and epidemiological literature and over-generelization has become the norm.
There is a widely accepted belief that women use health services, particularly mental health services, more than men. Haavio-Manila has, however, reported that while women had higher psychiatric admission rates than men in Norway, in Finland and Sweden men had higher rates (Haavio-Manila E. Inequalities in health and gender. Soc. Sci. Med. 22, 141, 1986.) Why are more recent data more complex to understand than older studies in the field of gender differences? One possibility is that female/male differences in health have changed over time (in the same way that male/female differences in life expectancy may have changed over time (Macintyre S. Gender differences in longevity and health in Eastern and Western Europe. In Locating Health: Sociological and Historial Explanations (Edited by Platt S., Thomas H., Scott S. and Williams G.), pp. 57-74. Avebury, Aldershot, 1993.
If we are to make progress towards understanding to whether social, psychological or biological produce or maintain gender differences in health, it is important to pay attention to the social and historical context of the observations, and to take a more differentiated agespecific and condition-specific view of 'health' when examining differences between the sexes.
(Wingard D. L., Cohn B. A., Kaplan G. A., Cirillo P. M. and Cohen R. D. Sex differentials in morbidity and mortality risks examined by age and cause in the same cohort. Am. J. Epidemiol. 130, 601, 1989. )
National Quality Registers
A National Quality Registry contains individualised data concerning patient problems, medical interventions, and outcomes after treatment; within all healthcare production. It is annually monitored and approved for financial support by an Executive Committee.
Swedish Neuro Registries is a quality register with the aim of ensuring that neurological care is equitable and of high quality and to ensure treatment guidelines are being followed.
Swedish Neuro Registries are represented in all counties and all hospitals where neurological care is provided. It will be the base for national neurological research.
The registry started as an MS registry in 1996. In 2012, it became Swedish Neuro Registries with 8 diagnosis: Multiple Sclerosis, Parkinson's Disease, Myasthenia Gravis , Narcolepsy, Epilepsy, Motor Neuron Disease, Inflammatory Polyneuropathy and Severe Neurovascular Headache. REFERENS:( http://kvalitetsregister.se/englishpages/findaregistry/registerarkivenglish/nationalqualityregistryforneurologicalcareneuroregpreviouslyswedishmsregistry.2283.html Today abou 5800 patients are registered within the PD registry, of which about 4600 with a diagnose of PD or related disorders such as parkinsonism, atypical PD etcetera.
- Conditions
- Parkinson Disease
- Being tested
- inquiries
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inquiriesOther
Inquires reported to clinician.
| Study group | Role | What they receive |
|---|---|---|
| idiopathic parkinson | Classical Parkinson´s disease, idiopathic Receives: Other: inquiries | |
| secondary parkinsonism | parkinsonism due to other reasons than idiopathic Receives: Other: inquiries | |
| controls | persona matched by age and gender, non parkinsonism Receives: Other: inquiries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of selfreported motor and non-motor symptoms with The Parkinson´s Well-being map
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.
Measured: 12 months
Secondary outcomes (1)
Prevalence of combinations of reported motor and non-motor symptoms using
Secondary outcome measures are to study commonly reported combinations of non-motor symptoms within the groups, with respect to gender and duration of disease.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start1 Jan 2016
- Primary completion31 Dec 2016
- Study completion31 Jul 2017
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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örjan Skogar
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Örjan Skogar, Region Jönköping County
- Investigators
- Boel Andersson Gäre, PhD, Study director, Region Jönköping County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432338
- Sponsor's protocol ID
- Dnr 2016/118-31
- Status last verified
- Mar 2021
- First submitted
- 1 Sep 2017
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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™
- ClinicalTrials.gov ID
- NCT03432338
- Acronym / sponsor ID
- Dnr 2016/118-31
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Örjan SkogarOther government
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 14 Feb 2018 (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.
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.
Detailed description
Over the past decades knowledge of the natural history and progression of Parkinson´s disease (PD) has increased. Age at onset, time to troublesome complications are well described. Parallell to this, the society has been more and more aware of differences between gender in the expressions of diseases. Differences in self reported experiences are of great interest as this is tightly interconnected with Health Related Quality of Life, (HRQoL).
The incidence of PD rapidly increase over the age of 60 years (y) , with only 4% of the cases being under the age of 50 y. The rate for men 19.0 per 100,000, was 91% higher than that for women (9.9 per 100,000 )The age- and gender-adjusted rate per 100,000 was highest among Hispanics (16.6,non-Hispanic Whites ,Asians (11.3, and Blacks (10.2). These data suggest that the incidence of Parkinson's disease varies by race/ethnicity.
( ref. Van den Eeden 2003)
Nonmotor Symptoms in Parkinson's Disease:
Of the nine domains in the validated NMSS (Chaudhuri, Martinez- Martin, Brown, et al., 2007), sexual dysfunction and mood changes have been commonly observed to have associations with specific gender. While sexual dysfunction has been commonly reported with a significantly higher proportion among men (Kova ́cs, Makkos, Aschermann, et al., 2016; Martinez-Martin, Falup Pecurariu, Odin, et al., 2012; Picillo, Amboni, Erro, et al., 2013; Solla, Cannas, Ibba, et al., 2012; Szewczyk- Krolikowski, Tomlinson, Nithi, et al., 2014), mood symptoms, which encompass loss of interest in surroundings, lack of motivation, feeling ner- vous, flat mood, and difficulty in experiencing pleasure, have been frequently reported among women in a higher proportion compared to men with PD (Guo, Song, Chen, et al., 2013; Martinez-Martin et al., 2012; Nicoletti, Vasta, Mostile, et al., 2017; Solla et al., 2012; Song, Gu, An, \& Chan, 2014).
It is well known that in the general population ( not specific parkinsonism ) in industrialized societies men die earlier than women but that women have poorer health than men. Differences discussed are differences in biological risks and acquired risks . But studies have revealed that the variations in health experiences depend on the particular symptom or condition in question and also according to the phase of the life cycle.
Already In an article by S.Macintyre et al from 1996 two large British surveys were examined and revealed a larger complexity than earlier studies had shown in the description of health surveys and differences between gender. These often described the consistency of reporting more illness , poorer self-evaluation of health and higher rates of psychosocial malaise in women than in men.
In this study more complex patterns of sex differences were shown for different symptoms reported. 'Worrying', 'nerves', 'always tired', 'headaches', 'constipation' and 'fainting or dizziness' showed the most consistent female excess. Sickness, nausea or stomach trouble were only dominating among 18 year old females and 'trouble with eyes' among 56-60 year olds in another large survey. In contrast, two symptoms, 'palpitations' and 'trouble with ears' show a male excess among middle aged. Female excess was only consistently found across the life span for the more psychological manifestations of distress, and was far less apparent for a number of physical symptoms and conditions.
Problems relating to reproduction will naturally show a female excess in the childbearing years, hormonal differences are apparent before and after the menopause.
Probably an oversimplification have been the fact in older sociological and epidemiological literature and over-generelization has become the norm.
There is a widely accepted belief that women use health services, particularly mental health services, more than men. Haavio-Manila has, however, reported that while women had higher psychiatric admission rates than men in Norway, in Finland and Sweden men had higher rates (Haavio-Manila E. Inequalities in health and gender. Soc. Sci. Med. 22, 141, 1986.) Why are more recent data more complex to understand than older studies in the field of gender differences? One possibility is that female/male differences in health have changed over time (in the same way that male/female differences in life expectancy may have changed over time (Macintyre S. Gender differences in longevity and health in Eastern and Western Europe. In Locating Health: Sociological and Historial Explanations (Edited by Platt S., Thomas H., Scott S. and Williams G.), pp. 57-74. Avebury, Aldershot, 1993.
If we are to make progress towards understanding to whether social, psychological or biological produce or maintain gender differences in health, it is important to pay attention to the social and historical context of the observations, and to take a more differentiated agespecific and condition-specific view of 'health' when examining differences between the sexes.
(Wingard D. L., Cohn B. A., Kaplan G. A., Cirillo P. M. and Cohen R. D. Sex differentials in morbidity and mortality risks examined by age and cause in the same cohort. Am. J. Epidemiol. 130, 601, 1989. )
National Quality Registers
A National Quality Registry contains individualised data concerning patient problems, medical interventions, and outcomes after treatment; within all healthcare production. It is annually monitored and approved for financial support by an Executive Committee.
Swedish Neuro Registries is a quality register with the aim of ensuring that neurological care is equitable and of high quality and to ensure treatment guidelines are being followed.
Swedish Neuro Registries are represented in all counties and all hospitals where neurological care is provided. It will be the base for national neurological research.
The registry started as an MS registry in 1996. In 2012, it became Swedish Neuro Registries with 8 diagnosis: Multiple Sclerosis, Parkinson's Disease, Myasthenia Gravis , Narcolepsy, Epilepsy, Motor Neuron Disease, Inflammatory Polyneuropathy and Severe Neurovascular Headache. REFERENS:( http://kvalitetsregister.se/englishpages/findaregistry/registerarkivenglish/nationalqualityregistryforneurologicalcareneuroregpreviouslyswedishmsregistry.2283.html Today abou 5800 patients are registered within the PD registry, of which about 4600 with a diagnose of PD or related disorders such as parkinsonism, atypical PD etcetera.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| idiopathic parkinson | – | Other: inquiriesClassical Parkinson´s disease, idiopathic |
| secondary parkinsonism | – | Other: inquiriesparkinsonism due to other reasons than idiopathic |
| controls | – | Other: inquiriespersona matched by age and gender, non parkinsonism |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (1 listed)
- " Clinical diagnosis of Idiopathic Parkinson´s Disease " Clinical diagnosos of secondary parkinsonism " Healthy controls " Age >65 years " >1 year duration of disease after diagnose
Key exclusion criteria (1 listed)
- " Participation in other studies " Severe disease of psychiatric origin " Severe cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inquiriesInquires reported to clinician. | Other | controls, idiopathic parkinson, secondary parkinsonism |
Primary outcome
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.
1 secondary outcome
Prevalence of combinations of reported motor and non-motor symptoms using
Time frame: 12 months
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 12 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
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.
Boel Andersson Gäre, PhD study director
Region Jönköping County
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Örjan Skogar.
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 1 inclusion and 1 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 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Prevalence of selfreported motor and non-motor symptoms with The Parkinson´s Well-being map (time frame: 12 months). 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 12 Mar 2021.