Parkinson's DiseaseProdDiGYParkNCT02627664
Study of Dysarthria, Swallowing Disorders and Respiratory in Parkinson's Disease
An observational study of Parkinson's Disease, run by University Hospital, Lille at 1 site in France.
Trial summary
The investigators prospectively enrolled 64 early PD patients (less than 3 years after the first symptom) in order to prospectively assess the natural history of non-dopaminergic symptoms. Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- observational study
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2011to 9 Feb 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 35 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Parkinson's disease (PD) with early idiopathic ( ≤ 5 years of evolution )
Who may be able to join
- idiopathic parkinson's disease
Who cannot join
- dementia
- severe axial gait disorders
- respiratory or ENT pathology
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study of Dysarthria, Swallowing Disorders and Respiratory in Parkinson's Disease
The investigators prospectively enrolled 64 early PD patients (less than 3 years after the first symptom) in order to prospectively assess the natural history of non-dopaminergic symptoms.
Read the detailed description
Patients were evaluated at baseline and after 2 years in off drug condition. Clinical, psychological, neuropsychological evaluations, functional respiratory evaluation, swallowing video fluoroscopy, dysarthria, gait and axial disorders.
- Conditions
- Parkinson's Disease
- Being tested
- observational study
- Keywords
- Idiopathic early, Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
natural history of non dopaminergic signs
| Study group | Role | What they receive |
|---|---|---|
| observational study | natural history of non dopaminergic signs Receives: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
dysarthria severity assessed by the BECD scale
BECD (French battery of clinical evaluation of the dysarthria) is a validated scale for qualitative assessment of dysarthria severity in neurological disorders, especially PD
Measured: 2 years
Secondary outcomes (9)
respiratory insufficiency detection
pulmonary function tests include spirometry with standard spirometer and maximal inspiratory and expiratory flow volume curves . At least 3 reproductible F-V curves are necessary. Values of FCV, FEV, peak expiratory flow, peak inspiratory flow, forced expiratory flow, SNIP were measured 12 hours after last levodopa intake (off drug)
Measured: 2 years
swallowing function
150 mL glass of water test video fluoroscopy of swallow in off drug condition face and profile incidences: qualitative analysis of oral, pharyngeal, aspiration if necessary blindly assessed by 2 ENT experts in PD
Measured: 2 years
gait axial function (freezing)
SWS test rhythmic tests for differens imposed frequencies (upper lower limb and facial) kinematic analysis of gait parameters by VICON (oxford metrics)
Measured: 2 years
Mattis scale
Measured: 2 years
LARS scale
Measured: 2 years
MADRS scale
Measured: 2 years
PAS scale
Measured: 2 years
MoCA
Measured: 2 years
Genetic Polymorphisme
To evaluate of cognitive and profile correlation to the polymorphisms of COMT (catechol-O-methyltransferase: Val158Met COMT) of MAPT H1 / H2 (microtubule associated tau protein) and ApoE (Apolipoprotein-E-ε2, 3, 4 )
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startMar 2011
- Primary completion9 Feb 2017
- Study completion9 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- France Parkinson Association
- Responsible party
- Sponsor
- Investigators
- luc defebvre, MD PhD, Study chair, CHRU LILLE FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627664
- Sponsor's protocol ID
- 2010_21
- Other IDs
- 2010-A01391-38
- Acronym
- ProdDiGYPark
- Status last verified
- May 2017
- First submitted
- 18 Dec 2014
- Last updated
- 18 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Dysarthria, Swallowing Disorders and Respiratory in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02627664
- Acronym / sponsor ID
- ProdDiGYPark / 2010_21
- Conditions
- Parkinson's Disease
- Keywords
- Idiopathic early, Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- France Parkinson Association
- Study start
- Mar 2011 (actual)
- Primary completion
- 9 Feb 2017 (actual)
- Study completion
- 9 Feb 2017 (actual)
- First posted
- 11 Dec 2015 (estimated)
- 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.
The investigators prospectively enrolled 64 early PD patients (less than 3 years after the first symptom) in order to prospectively assess the natural history of non-dopaminergic symptoms.
Detailed description
Patients were evaluated at baseline and after 2 years in off drug condition. Clinical, psychological, neuropsychological evaluations, functional respiratory evaluation, swallowing video fluoroscopy, dysarthria, gait and axial disorders.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational study | – | Other: observational studynatural history of non dopaminergic signs |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's disease (PD) with early idiopathic ( ≤ 5 years of evolution )
Key inclusion criteria (1 listed)
- idiopathic parkinson's disease
Key exclusion criteria (4 listed)
- dementia
- severe axial gait disorders
- respiratory or ENT pathology
- Pregnancy
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 |
|---|---|---|
| observational studynatural history of non dopaminergic signs | Other | observational study |
Primary outcome
dysarthria severity assessed by the BECD scale
Time frame: 2 years
BECD (French battery of clinical evaluation of the dysarthria) is a validated scale for qualitative assessment of dysarthria severity in neurological disorders, especially PD
9 secondary outcomes
respiratory insufficiency detection
Time frame: 2 years
swallowing function
Time frame: 2 years
gait axial function (freezing)
Time frame: 2 years
Mattis scale
Time frame: 2 years
LARS scale
Time frame: 2 years
MADRS scale
Time frame: 2 years
PAS scale
Time frame: 2 years
MoCA
Time frame: 2 years
Genetic Polymorphisme
Time frame: 2 years
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 18 May 2017.
- Individual participant dataSharing planned: No
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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.
luc defebvre, MD PhD study chair
CHRU LILLE FRANCE
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's Disease, run by University Hospital, Lille at 1 site in France.
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 4 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 18 May 2017. 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 France. 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?
dysarthria severity assessed by the BECD scale (time frame: 2 years). 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 18 May 2017.