Parkinson's DiseaseSYNAParkNCT01748409
Physiopathological Study of Autonomic Failure in Parkinson's Disease
A study testing Biopsies of peripheral autonomic nervous system, Autonomic dysfunction questionnaires and Electrophysiological tests in people with Parkinson's Disease, run by Nantes University Hospital at 1 site in France.
Trial summary
The aim of the study is to evaluate the autonomic failure in Parkinson's disease by clinical, electrophysiological and neuropathological examination. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Biopsies of peripheral autonomic nervous system, Autonomic dysfunction questionnaires and Electrophysiological tests
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to Mar 2016
- Phase
- Interventional
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Parkinson's disease
- ages 45 to 80 years, both genders
- patients who signed informed consent
Who cannot join
- autonomic function modifying treatment
- pre-existing neuropathy or risk factors for neuropathy
- dementia
- colonic disorders
- coagulation disorders (may be due to treatment)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiopathological Study of Autonomic Failure in Parkinson's Disease : a Monocentric Study
The aim of the study is to evaluate the autonomic failure in Parkinson's disease by clinical, electrophysiological and neuropathological examination.
- Conditions
- Parkinson's Disease
- Being tested
- Biopsies of peripheral autonomic nervous system, Autonomic dysfunction questionnaires, Electrophysiological tests
- Keywords
- Autonomic failure, Parkinson's disease, electrophysiological assessment, neuropathological assessment
- Medical subject headings
- Parkinson Disease, Pure Autonomic Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsies of peripheral autonomic nervous systemOther
Autonomic dysfunction questionnairesOther
Also called a battery of questionaries to evaluate autonomic neurological patient complaints and dysfunctions.
Electrophysiological testsOther
Also called A battery of electrophysiological tests to assess neurological functions
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate association between clinical autonomic failure and neuropathological autonomic failure on biopsies.
the main objective is to look after associations between :
- anatomopathological signs of autonomic nervous system disorders seen on biopsies AND
- clinical signs of signs of autonomic nervous system disorders seen through functional tests or through symptoms indicated by the patient on questionaries.
Measured: 3 months
Secondary outcomes (2)
Evaluate association between autonomic failure and severity factors in Parkinson's disease
Autonomic failure will be assessed through questionaries on symptoms and through functional tests.
Severity factors in parkinson disease will refer to various parameters like patient age.
Measured: 3 months
Evaluate consequences of autonomic failure on quality of life and sleep quality
quality of life and of sleep will be assessed through functional tests and through questionaries.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startFeb 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748409
- Sponsor's protocol ID
- RC12_0264
- Acronym
- SYNAPark
- Status last verified
- Oct 2016
- First submitted
- 10 Dec 2012
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Sadoc M, Clairembault T, Coron E, Berthomier C, Le Dily S, Vavasseur F, Pavageau A, St Louis EK, Pereon Y, Neunlist M, Derkinderen P, Leclair-Visonneau L. Wake and non-rapid eye movement sleep dysfunction is associated with colonic neuropathology in Parkinson's disease. Sleep. 2024 Mar 11;47(3):zsad310. doi: 10.1093/sleep/zsad310.
PubMed 38156524
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiopathological Study of Autonomic Failure in Parkinson's Disease : a Monocentric Study
- ClinicalTrials.gov ID
- NCT01748409
- Acronym / sponsor ID
- SYNAPark / RC12_0264
- Conditions
- Parkinson's Disease
- Keywords
- Autonomic failure, Parkinson's disease, electrophysiological assessment, neuropathological assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 12 Dec 2012 (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 aim of the study is to evaluate the autonomic failure in Parkinson's disease by clinical, electrophysiological and neuropathological examination.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with Parkinson's disease
- ages 45 to 80 years, both genders
- patients who signed informed consent
Key exclusion criteria (5 listed)
- autonomic function modifying treatment
- pre-existing neuropathy or risk factors for neuropathy
- dementia
- colonic disorders
- coagulation disorders (may be due to treatment)
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 |
|---|---|---|
| Biopsies of peripheral autonomic nervous system | Other | – |
| Autonomic dysfunction questionnairesAlso: a battery of questionaries to evaluate autonomic neurological patient complaints and dysfunctions. | Other | – |
| Electrophysiological testsAlso: A battery of electrophysiological tests to assess neurological functions | Other | – |
Primary outcome
Evaluate association between clinical autonomic failure and neuropathological autonomic failure on biopsies.
Time frame: 3 months
the main objective is to look after associations between : * anatomopathological signs of autonomic nervous system disorders seen on biopsies AND * clinical signs of signs of autonomic nervous system disorders seen through functional tests or through symptoms indicated by the patient on questionaries.
2 secondary outcomes
Evaluate association between autonomic failure and severity factors in Parkinson's disease
Time frame: 3 months
Evaluate consequences of autonomic failure on quality of life and sleep quality
Time frame: 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 5 Oct 2016.
- Derived from this study: PubMed 38156524Sadoc M, Clairembault T, Coron E, Berthomier C, Le Dily S, Vavasseur F, Pavageau A, St Louis EK, Pereon Y, Neunlist M, Derkinderen P, Leclair-Visonneau L. Wake and non-rapid eye movement sleep dysfunction is associated with colonic neuropathology in Parkinson's disease. Sleep. 2024 Mar 11;47(3):zsad310. doi: 10.1093/sleep/zsad310.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsies of peripheral autonomic nervous system, Autonomic dysfunction questionnaires and Electrophysiological tests in people with Parkinson's Disease, run by Nantes University Hospital 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 3 inclusion and 5 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 5 Oct 2016. 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?
Evaluate association between clinical autonomic failure and neuropathological autonomic failure on biopsies. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01748409, which also lists 1 linked publication.
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 5 Oct 2016.