Temporal Expectations in Parkinson's Disease

Healthy Clinical Trial

— PEDUPARK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02126475
• Other study ID #: C12-45
• Secondary ID: 2012-A01056-37
• Status: Recruiting
• Phase: N/A
• First received: April 28, 2014
• Last updated: February 3, 2015
• Start date: April 2014
• Est. completion date: October 2016

Study information

• Verified date: February 2015
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: bertrand DEGOS, PD-PhD
• Phone: 33-1-42-161762
• Email: bertrand.degos[@]psl.aphp.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy
• Parkinson Disease
• Parkinsons Disease

Locations

Country	Name	City	State
France	ICM	Paris
France	ICM-IHU	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oculomotor reaction time: saccade latency		at least 21 days after inclusion	No