PEDUPARK: Temporal Expectations in Parkinson's Disease

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France (Other)

Overall Status

Unknown status

CT.gov ID

NCT02126475

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinsons Disease Healthy

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

L'Expectation Temporelle Dans la Maladie de Parkinson : étude Oculomotrice Psychophysique et Par électroencéphalographie

Study Start Date :

Apr 1, 2014

Anticipated Primary Completion Date :

Oct 1, 2016

Anticipated Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Healthy volunteers
Park patients

Outcome Measures

Primary Outcome Measures

oculomotor reaction time: saccade latency [at least 21 days after inclusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ICM-IHU	Paris		France	75013
2	ICM	Paris		France	75013

Sponsors and Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

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