Parkinson DiseaseProdygi-IINCT03517059
Study of Dysarthria, and the Appearance of Non-dopaminergic Signs in Idiopathic PARKinson's Disease
An observational study of Parkinson Disease, run by University Hospital, Lille at 1 site in France.
Trial summary
Pilot study: Longitudinal follow up of the PRODY-GI cohort for parkinson's disease (PD) Observational study of upper and lower axial symptoms' occurence in 30 PD patients in on and off drug conditions, 30 aged matched control subjects and 10 control subjects with supra nuclear palsy Multi modal approach: functional… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- 11 May 2017to 12 Nov 2018
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Parkinson's disease (PD)
Who may be able to join
- Parkinson's Disease group :
- Patients with Parkinson's Disease, who where included in the PRODYGI-1 cohort still meeting the MP criteria, Always followed in the service of neurology and pathology of the movement.
- Pathological control group:
- Patients suffering from Richardson syndrome.
- Aged over 18
- Healthy control group:
Show all 9Show fewer
- Age-matched (± 5 years)
- Recruited on the basis of volunteering.
- free from any progressive neurological pathology after clinical examination and MoCA.
Who cannot join
- For all groups:
- Pregnant or lactating woman
- Extra-neurological severe respiratory pathology
- Terminal heart failure
- Contraindication to MRI
- Refusal / withdrawal / inability to give consent
- ENT pathology.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study of Dysarthria, and the Appearance of Non-dopaminergic Signs in Idiopathic PARKinson's Disease
Pilot study:
- Longitudinal follow up of the PRODY-GI cohort for parkinson's disease (PD)
- Observational study of upper and lower axial symptoms' occurence in 30 PD patients in on and off drug conditions, 30 aged matched control subjects and 10 control subjects with supra nuclear palsy
- Multi modal approach: functional MRI, clinical , ENT assessment, respiratory assessment, neuropsychological and gait evaluations
Read the detailed description
Prospective, clinical assessment of :
- Cognition and diadochokinetic task during fMRI in 30 PD patients (in off and on condition)
- Motor assessment using VICON gait and balance analysis
- Pulmonary functional testing in OFF and ON drug condition
- Quality of life
- Clinical neurological MDS UPDRS , N Fog questionnaire
- ENT and speech therapist evaluation in OFF and ON drug condition
- Conditions
- Parkinson Disease
- Keywords
- Levodopa, axial symptoms
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PD patients | 30 PD patients in ON and OFF levodopa conditions | |
| Healthy control subjects | 30 age matched healthy control subjects | |
| Neurological control subjects | 10 patients with defined supra nuclear palsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the neural network between patients in OFF levodopa conditions and control subjects
Measure evaluated by functional MRI during the realisation of a cognitive task: symbol digit modality test
Measured: Between two evaluation visits, on average at 3 months (baseline- 3 months)
Secondary outcomes (4)
Change in the neural network between patients in OFF-drug conditions and healthy control subjects
Measure evaluated by functional MRI during the realisation of two motor tasks
Measured: Between two evaluation visits, on average at 3 months (baseline- 3 months)
Change in the neural network between patients in OFF-drug conditions and healthy control subjects
Measure evaluated by resting state functional MRI
Measured: Between two evaluation visits, on average at 3 months (baseline- 3 months)
Change in the neural network between OFF-drug condition and ON-drug condition in patients
Measure evaluated by functional MRI, during the realisation of one cognitive task and two motor tasks
Measured: Between two evaluation visits, on average at 3 months (baseline- 3 months)
Change in the neural network between patients in OFF-drug conditions and neurological control subjects (with supra nuclear palsy)
Measure evaluated by functional MRI, during the realisation of one cognitive task and two motor tasks
Measured: Between two evaluation visits, on average at 3 months (baseline- 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start11 May 2017
- Primary completion12 Nov 2018
- Study completion12 Nov 2018
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- France Parkinson Association
- Responsible party
- Sponsor
- Investigators
- Caroline MOREAU, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517059
- Sponsor's protocol ID
- 2015_89
- Other IDs
- 2016-A01544-47
- Acronym
- Prodygi-II
- Status last verified
- Sep 2020
- First submitted
- 24 Apr 2018
- Last updated
- 23 Dec 2025
- 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 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Dysarthria, and the Appearance of Non-dopaminergic Signs in Idiopathic PARKinson's Disease
- ClinicalTrials.gov ID
- NCT03517059
- Acronym / sponsor ID
- Prodygi-II / 2015_89
- Conditions
- Parkinson Disease
- Keywords
- Levodopa, axial symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- France Parkinson Association
- Study start
- 11 May 2017 (actual)
- Primary completion
- 12 Nov 2018 (actual)
- Study completion
- 12 Nov 2018 (actual)
- First posted
- 7 May 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.
Pilot study:
- Longitudinal follow up of the PRODY-GI cohort for parkinson's disease (PD)
- Observational study of upper and lower axial symptoms' occurence in 30 PD patients in on and off drug conditions, 30 aged matched control subjects and 10 control subjects with supra nuclear palsy
- Multi modal approach: functional MRI, clinical , ENT assessment, respiratory assessment, neuropsychological and gait evaluations
Detailed description
Prospective, clinical assessment of :
- Cognition and diadochokinetic task during fMRI in 30 PD patients (in off and on condition)
- Motor assessment using VICON gait and balance analysis
- Pulmonary functional testing in OFF and ON drug condition
- Quality of life
- Clinical neurological MDS UPDRS , N Fog questionnaire
- ENT and speech therapist evaluation in OFF and ON drug condition
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PD patients | – | –30 PD patients in ON and OFF levodopa conditions |
| Healthy control subjects | – | –30 age matched healthy control subjects |
| Neurological control subjects | – | –10 patients with defined supra nuclear palsy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's disease (PD)
Key inclusion criteria (9 listed)
- Patients with Parkinson's Disease, who where included in the PRODYGI-1 cohort still meeting the MP criteria, Always followed in the service of neurology and pathology of the movement.
- Patients suffering from Richardson syndrome.
- Aged over 18
- Age-matched (± 5 years)
- Recruited on the basis of volunteering.
Key exclusion criteria (7 listed)
- Pregnant or lactating woman
- Extra-neurological severe respiratory pathology
- Terminal heart failure
- Contraindication to MRI
- Refusal / withdrawal / inability to give consent
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
Change in the neural network between patients in OFF levodopa conditions and control subjects
Time frame: Between two evaluation visits, on average at 3 months (baseline- 3 months)
Measure evaluated by functional MRI during the realisation of a cognitive task: symbol digit modality test
4 secondary outcomes
Change in the neural network between patients in OFF-drug conditions and healthy control subjects
Time frame: Between two evaluation visits, on average at 3 months (baseline- 3 months)
Change in the neural network between patients in OFF-drug conditions and healthy control subjects
Time frame: Between two evaluation visits, on average at 3 months (baseline- 3 months)
Change in the neural network between OFF-drug condition and ON-drug condition in patients
Time frame: Between two evaluation visits, on average at 3 months (baseline- 3 months)
Change in the neural network between patients in OFF-drug conditions and neurological control subjects (with supra nuclear palsy)
Time frame: Between two evaluation visits, on average at 3 months (baseline- 3 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 23 Dec 2025.
- 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.
Caroline MOREAU, MD principal investigator
University Hospital, Lille
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 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 9 inclusion and 7 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 23 Dec 2025. 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?
Change in the neural network between patients in OFF levodopa conditions and control subjects (time frame: Between two evaluation visits, on average at 3 months (baseline- 3 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 23 Dec 2025.