Parkinson's DiseaseDYNIDEONCT02894320
Dynamic ASPECTS of Internal PRE-ACTIVATION of Effects Sensors of Voluntary ACTION in PARKINSON's Disease
An observational study of Parkinson's Disease, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
The ability to predict sensory effects of people's own motor actions is a key component of Human action realization. Recent studies revealed this anticipation process to be involved in early and late stages of voluntary actions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Behavioral observation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2015to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with Parkinson's disease, according to the MDS-UPDRS III (Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale), matched for gender and for age with healthy subjects from a database. This database has already been constituted by the CNRS (Centre national de la recherche scientifique, Laboratory of Psychology of Perception - UMR8242).
Who may be able to join
- Adults age 18 years and older
- Parkinson's disease
Who cannot join
- Other pathology or neurological or psychiatric history
- Known pregnancy or breastfeeding
- Absence of affiliation to social security or universal health coverage (CMU)
- Person under legal protection
- Patient's opposition to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Parkinson's Disease on Internal Preactivation of Sensory Effects of Intention-based Actions. A Subliminal Priming Study
The ability to predict sensory effects of people's own motor actions is a key component of Human action realization. Recent studies revealed this anticipation process to be involved in early and late stages of voluntary actions. Nevertheless, the question whether the action-effect anticipation is impacted or not by "motor pathologies", such as the Parkinson's disease, remains unclear. The current study is aimed to clarify this issue by using a subliminal priming paradigm in patients with Parkinson's disease and in matched control participants. Indeed, subliminal primes corresponding to visual action-effects are displayed at different time points before the actions' execution. Results should allow to determine whether or not the action-effect prediction is impaired at different stages of voluntary action in patients with Parkinson's disease.
- Conditions
- Parkinson's Disease
- Being tested
- Behavioral observation
- Keywords
- Parkinson's disease, Voluntary action, Action-effect preactivation, Action-effect prediction
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral observationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease | Not described Receives: Behavioral: Behavioral observation | |
| Healthy subjects | gender and age matched with Parkinson's disease patients, whose data will be extracted from an existing database Receives: Behavioral: Behavioral observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction time
time measured in seconds
Measured: baseline
error rate
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startMar 2015
- Primary completionJun 2016
- Study completionSep 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 Fondation Ophtalmologique Adolphe de RothschildThe 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
- Cross-sectional
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894320
- Sponsor's protocol ID
- JBL_2014-28
- Acronym
- DYNIDEO
- Status last verified
- Aug 2018
- First submitted
- 5 Sep 2016
- Last updated
- 31 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Parkinson's Disease on Internal Preactivation of Sensory Effects of Intention-based Actions. A Subliminal Priming Study
- ClinicalTrials.gov ID
- NCT02894320
- Acronym / sponsor ID
- DYNIDEO / JBL_2014-28
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Voluntary action, Action-effect preactivation, Action-effect prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Mar 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 9 Sep 2016 (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 ability to predict sensory effects of people's own motor actions is a key component of Human action realization. Recent studies revealed this anticipation process to be involved in early and late stages of voluntary actions. Nevertheless, the question whether the action-effect anticipation is impacted or not by "motor pathologies", such as the Parkinson's disease, remains unclear. The current study is aimed to clarify this issue by using a subliminal priming paradigm in patients with Parkinson's disease and in matched control participants. Indeed, subliminal primes corresponding to visual action-effects are displayed at different time points before the actions' execution. Results should allow to determine whether or not the action-effect prediction is impaired at different stages of voluntary action in patients with Parkinson's disease.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease | – | Behavioral: Behavioral observation |
| Healthy subjects | – | Behavioral: Behavioral observationgender and age matched with Parkinson's disease patients, whose data will be extracted from an existing database |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with Parkinson's disease, according to the MDS-UPDRS III (Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale), matched for gender and for age with healthy subjects from a database. This database has already been constituted by the CNRS (Centre national de la recherche scientifique, Laboratory of Psychology of Perception - UMR8242).
Key inclusion criteria (2 listed)
- Adults age 18 years and older
- Parkinson's disease
Key exclusion criteria (5 listed)
- Other pathology or neurological or psychiatric history
- Known pregnancy or breastfeeding
- Absence of affiliation to social security or universal health coverage (CMU)
- Person under legal protection
- Patient's opposition to participate
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 |
|---|---|---|
| Behavioral observation | Behavioural | Healthy subjects, Parkinson's disease |
Primary outcome
Reaction time
Time frame: baseline
time measured in seconds
error rate
Time frame: baseline
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 31 Aug 2018.
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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?
An observational study of Parkinson's Disease, run by Fondation Ophtalmologique Adolphe de Rothschild 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 2 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 31 Aug 2018. 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?
Reaction time (time frame: baseline). The study lists 2 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 31 Aug 2018.