Clinical trial NCT02126475: Temporal Expectations in Parkinson's Disease
Official title: L'expectation Temporelle Dans La Maladie De Parkinson : Étude Oculomotrice Psychophysique Et Par Électroencéphalographie
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinsons Disease
Healthy
Keywords: parkinson patients "ON"
parkinson patients "OFF"
time estimation
anticipation
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2014-04-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers and Parkinson patients, non fluctuent

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.


Eligibility criteria: Inclusion Criteria:

1. 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
2. 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

Primary outcomes:
measure: oculomotor reaction time: saccade latency
timeFrame: at least 21 days after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: ICM-IHU
city: Paris
country: France
facility: ICM
Study officials:
affiliation: Département des Maladies du Système Nerveux, Groupe Hospitalier Pitié-Salpêtrière 47-83 boulevard de l'Hôpital 75651 PARIS Cedex 13
name: Bertrand DEGOS, MD-PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: nstitute of Neurosciences IoNs . Groupe COSY. 53 av. Mounier Boîte B1.53.4 COSY 1200 Bruxelles Belgique
name: Marcus MISSAL, Pr-PhD
role: STUDY_DIRECTOR
affiliation: ICM, CNRS, INSERM, Université Pierre et Marie Curie Hôpital de la Salpêtrière 47 boulevard de l'Hôpital 75651 Paris CEDEX 13 France
name: Pierre POUGET, PhD
role: STUDY_DIRECTOR
References: