- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02126475
Temporal Expectations in Parkinson's Disease (PEDUPARK)
L'Expectation Temporelle Dans la Maladie de Parkinson : étude Oculomotrice Psychophysique et Par électroencéphalographie
Although major progresses were realized during recent years, temporal cognition is still poorly understood. However, abnormal temporal cognition is an underestimated aspect of several neurological disorders, particularly if basal ganglia (BG) are affected. Therefore, the interest of studying temporal cognition is double: firstly, it is an essential function necessary to guide all behavior; secondly, it seems to be very sensitive to the integrity of dopaminergic pathways. It is well known that Parkinson's disease (PD) is partly due to a degeneration of neurons producing dopamine in the Substantia Nigra pars compacta (SNc). Therefore, in this project, PD patients and healthy volunteers will be used as a model to study the role of dopamine in temporal expectation.
An expectation is an internal representation of an event that is likely to occur in the future. Temporal expectation builds-up as time elapses before the upcoming event. The role of temporal expectation in the oculomotor domain has often been studied using anticipatory eye movements as a tool. Indeed, expectation evokes anticipatory eye movements. However, to the knowledge of the investigators, expectation and anticipation have so far been studied in experimental tasks where temporal information is essential but not voluntarily controlled. This is usually referred to as 'automatic' or 'emergent' timing: the timing of the eye movement adapts to the timing of the target, implicitly and without voluntary control of the subject. However, anticipatory movements can also be based on an explicit estimation of time, e.g. during music playing. In summary, timing can be based on cognitive (explicit) or automatic (implicit) processing. The originality of the behavioral task the investigators will use in this study is that it will require an explicit comparison of a memorized duration with elapsing time in order to anticipate target appearance. In this task, expectation of the upcoming event will build up on explicit temporal information.
Same PD patients will be tested under treatment ("ON") and without treatment ("OFF") to determine the effect of dopamine in time expectation . Only levodopa responsive Parkinson patients will be included and among them only those receiving levodopa and/or dopa agonists three times daily at a stable dosis since 30 days.
the investigators hypothesize that eye movements latency will not linearly covary with objective time in "OFF" PD patients. In treated PD patients, a recovery of the linear relationship between subjective and objective time is expected. This would clearly demonstrate the role of dopamine in temporal expectation in humans.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Paris, France, 75013
- Not yet recruiting
- ICM-IHU
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Sub-Investigator:
- ilhame ameqrane, PhD
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Paris, France, 75013
- Recruiting
- ICM
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Sub-Investigator:
- ilhame ameqrane, PhD
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Contact:
- bertrand degos, MD-PhD
- Email: bertrand.degos@psl.aphp.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Healthy volunteers :
- Men or women, age: 18 to 65 years old
- Subject affiliated to a national insurance scheme
- Informed consent of the study signed
- Normal neurological exam
Patients:
- Men or women, age: 18 to 65 years old
- Subject affiliated to a national insurance scheme
- Informed consent of the study signed
- Idiopathic Parkinson disease, UKPDSBB criteria (Hughes, Ben-Shlomo, Daniel, & Lees, 1992; Hughes, Daniel, Kilford, & Lees, 1992; Hughes, Daniel, & Lees, 2001)
- Non fluctuant patients
- Patients treated by L-Dopa +/- other anti-Parkinsonian's, stable dose for 30 days
Exclusion Criteria:
- Cognitive or behavioural disorder
- Severe psychiatric symptomatology and psychotropic drug use
- Subject non-affiliated to a national insurance scheme
- No signature of the Informed consent of the study
- Subject freedom-deprived by court or administrative order
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Healthy volunteers
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Park patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
oculomotor reaction time: saccade latency
Time Frame: at least 21 days after inclusion
|
at least 21 days after inclusion
|
Collaborators and Investigators
Investigators
- Principal Investigator: Bertrand DEGOS, MD-PhD, Département des Maladies du Système Nerveux, Groupe Hospitalier Pitié-Salpêtrière 47-83 boulevard de l'Hôpital 75651 PARIS Cedex 13
- Study Director: Marcus MISSAL, Pr-PhD, nstitute of Neurosciences IoNs . Groupe COSY. 53 av. Mounier Boîte B1.53.4 COSY 1200 Bruxelles Belgique
- Study Director: Pierre POUGET, PhD, ICM, CNRS, INSERM, Université Pierre et Marie Curie Hôpital de la Salpêtrière 47 boulevard de l'Hôpital 75651 Paris CEDEX 13 France
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C12-45
- 2012-A01056-37 (Registry Identifier: ID RCB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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