Parkinsons DiseasePEDUPARKNCT02126475
Temporal Expectations in Parkinson's Disease
An observational study of Parkinsons Disease and Healthy, run by Institut National de la Santé Et de la Recherche Médicale, France at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinsons Disease, Healthy
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- 29 Apr 2014to 16 Feb 2016
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers and Parkinson patients, non fluctuent
Who may be able to join
- 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:
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Parkinsons Disease, Healthy
- Keywords
- parkinson patients "ON", parkinson patients "OFF", time estimation, anticipation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Not described | |
| Park patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
oculomotor reaction time: saccade latency
Measured: at least 21 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study start29 Apr 2014
- Primary completion16 Feb 2016
- Study completion16 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinsons DiseaseStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Bertrand DEGOS, MD-PhD, Principal investigator, Département des Maladies du Système Nerveux, Groupe Hospitalier Pitié-Salpêtrière 47-83 boulevard de l'Hôpital 75651 PARIS Cedex 13Marcus MISSAL, Pr-PhD, Study director, nstitute of Neurosciences IoNs . Groupe COSY. 53 av. Mounier Boîte B1.53.4 COSY 1200 Bruxelles BelgiquePierre POUGET, PhD, Study director, ICM, CNRS, INSERM, Université Pierre et Marie Curie Hôpital de la Salpêtrière 47 boulevard de l'Hôpital 75651 Paris CEDEX 13 France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126475
- Sponsor's protocol ID
- C12-45
- Other IDs
- 2012-A01056-37
- Acronym
- PEDUPARK
- Status last verified
- Mar 2025
- First submitted
- 28 Apr 2014
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Degos B, Pouget P, Missal M. From anticipation to impulsivity in Parkinson's disease. NPJ Parkinsons Dis. 2022 Oct 3;8(1):125. doi: 10.1038/s41531-022-00393-w.
PubMed 36184657Degos B, Ameqrane I, Rivaud-Pechoux S, Pouget P, Missal M. Short-term temporal memory in idiopathic and Parkin-associated Parkinson's disease. Sci Rep. 2018 May 16;8(1):7637. doi: 10.1038/s41598-018-25751-8.
PubMed 29769545
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L'Expectation Temporelle Dans la Maladie de Parkinson : étude Oculomotrice Psychophysique et Par électroencéphalographie
- ClinicalTrials.gov ID
- NCT02126475
- Acronym / sponsor ID
- PEDUPARK / C12-45
- Conditions
- Parkinsons Disease, Healthy
- Keywords
- parkinson patients "ON", parkinson patients "OFF", time estimation, anticipation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 29 Apr 2014 (actual)
- Primary completion
- 16 Feb 2016 (actual)
- Study completion
- 16 Feb 2016 (actual)
- First posted
- 30 Apr 2014 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | – |
| Park patients | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers and Parkinson patients, non fluctuent
Key inclusion criteria (12 listed)
- Healthy volunteers :
- Patients:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
oculomotor reaction time: saccade latency
Time frame: at least 21 days after inclusion
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 10 Dec 2025.
- Results publication: PubMed 36184657Degos B, Pouget P, Missal M. From anticipation to impulsivity in Parkinson's disease. NPJ Parkinsons Dis. 2022 Oct 3;8(1):125. doi: 10.1038/s41531-022-00393-w.
- Results publication: PubMed 29769545Degos B, Ameqrane I, Rivaud-Pechoux S, Pouget P, Missal M. Short-term temporal memory in idiopathic and Parkin-associated Parkinson's disease. Sci Rep. 2018 May 16;8(1):7637. doi: 10.1038/s41598-018-25751-8.
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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.
Bertrand DEGOS, MD-PhD principal investigator
Département des Maladies du Système Nerveux, Groupe Hospitalier Pitié-Salpêtrière 47-83 boulevard de l'Hôpital 75651 PARIS Cedex 13
Marcus MISSAL, Pr-PhD study director
nstitute of Neurosciences IoNs . Groupe COSY. 53 av. Mounier Boîte B1.53.4 COSY 1200 Bruxelles Belgique
Pierre POUGET, PhD study director
ICM, CNRS, INSERM, Université Pierre et Marie Curie Hôpital de la Salpêtrière 47 boulevard de l'Hôpital 75651 Paris CEDEX 13 France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinsons Disease and Healthy, run by Institut National de la Santé Et de la Recherche Médicale, France at 2 sites 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 12 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 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
oculomotor reaction time: saccade latency (time frame: at least 21 days after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02126475, which also lists 2 linked publications.
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 10 Dec 2025.