Parkinson's DiseaseAGIRPARKNCT02488395
Superior Colliculus Activity in Parkinson Disease: a Potential Marker?
An observational study of Parkinson's Disease, run by Institut National de la Santé Et de la Recherche Médicale, France at 3 sites in France.
Trial summary
The ultimate goal of this project is to evaluate a possible new strategy to diagnose earlier Parkinson's disease, using the superior colliculus as a biomarker. Preliminary data from the investigator's group in a rat model of Parkinson's disease suggest that the superior colliculus, a sensory structure, show an early… Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- fMRI, Ophthalmologic evaluation and visual psychophysics test
- How many people
- 23 participants
- Where
- 3 sitesFrance
- Study dates
- 7 Oct 2015to 19 Jan 2018
- 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 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Groups of de novo Parkinson's patients and their age matching controls.
Who may be able to join
- De novo parkinson's patients being just diagnosed (stage 1 according to the Hoehn and Yahr scale: first unilateral signs with no discomfort in everyday life) without a current dopaminergic treatment and who have not started their anti-parkinsonian treatment.
- Both Parkinson's patients and their age matching control must not present a major visual pathology (mainly in the retina) which may interfere with the visual task.
- Signed informed and free consent.
- Matching controls must not present a neurological or psychiatric troubles.
- For the matching controls: There are no contraindication on current treatments apart from those to treat other neurological disease than Parkinson's disease or psychiatric troubles.
- For Parkinson's patients: There are no contraindication on current treatments apart from those to treat neurological troubles including anti-parkinsonian treatment, or psychiatric troubles.
- As a precaution, the investigators will check that no MRI exam has been performed during the week preceding our fMRI.
Who cannot join
- Parkinson's patients with important tremor limiting the validity of the fMRI acquisition.
- Adult under supervision
- Incapacity to understand the consent explanations.
- Impossibility to participate to the whole experimental protocol.
- No affiliation to a health insurance.
- Consent not signed by a participant or refusal by the participant to participate to the experiment.
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- Pregnancy or breast feeding woman.
- Administrative or justice freedom restricted participant.
- Pacemaker, neurosensorial stimulator or implanted defibrillator.
- Presence of ocular or cerebral ferromagnetic material.
- Respiratory disease (i.e. asthma), cardio-vascular deficits, claustrophobia
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de Grenoble
Grenoble, Isere, 38000
Grenoble Institute of Neurosciences
Grenoble, Isere, 38000
IRMAGE
Grenoble, Isere, 38000
About this study
Official title: Superior Colliculus Activity in Parkinson Disease: a Potential Marker? fMRI Brain Activation in Response to Visual Stimuli.
The ultimate goal of this project is to evaluate a possible new strategy to diagnose earlier Parkinson's disease, using the superior colliculus as a biomarker.
Preliminary data from the investigator's group in a rat model of Parkinson's disease suggest that the superior colliculus, a sensory structure, show an early deficit in visual processing. The investigator's data also suggests that with the evolution of the disease, this structure presents a neuronal re-organisation leading which causes a sensory rebound after the introduction of the treatment. The light responses in the superior colliculus were faster, bigger in amplitude and lasted longer (Rolland et al., 2012). Those results raise an important question about the superior colliculus functional state in Parkinson's patients. If this structure have a similar neuroplasticity, the investigators could hypothesize that the superior colliculus may also present a sensory rebound when introducing the treatment. If this hypothesis is true, the accelerated and amplified light responses of this structure may explain the difficulties felt by the patients to inhibit reflexive saccades induced by the appearance of unexpected visual stimuli. Indeed, the superior colliculus is involved in the orientation of the head and eye toward any sudden changes in our environment (Wurtz and Albano, 1980) and the light responses of this structure are strongly correlated with the speed of the saccade (Marino et al., 2012).
Therefore, the investigators want to test if a similar deficit could be observed in the superior colliculus of newly diagnosed PD patients. Data will be compared to matching controls.
Read the detailed description
This project aims at better understanding the physiopathology of Parkinson's disease and the effect of the administration of the classical medical treatment. The main aim of this project is to evaluate the possibility of an early detection using a new original strategy. The investigators want to demonstrate the predictive value of the superior colliculus light responses as an early biomarker.
The investigators will perform functional magnetic resonance imagery (fMRI) to measure the BOLD light responses of the superior colliculus at different key stages of the normal medical follow up of Parkinson's patients by the neurologist (when diagnosed, when introducing the first treatment and when the treatment is stabilised).
Two groups of participants will be tested: a) a group of de novo patients, which have just been diagnosed and haven't started their treatment; b) a group of matching controls.
A first fMRI session (S1) will be performed to compare the light induced BOLD response of the superior colliculus between de novo patients and their matching controls. This session will evaluate a possible visual processing dysfunction in the superior colliculus of newly diagnosed patients.
Parkinson's patients will then start their treatment and a second session (S2) will be done on this group shortly after the introduction of the treatment to measure its acute effect. If the superior colliculus of those patients presents a sensory rebound, the investigators should observe a bigger light-induced BOLD response after the treatment compared to before the treatment.
A third session (S3) will be performed after the optimal adjustment of the treatment on motor symptoms which would be around six month after the start of the treatment. This adjustment is long and difficult, realized by the neurologist according to its effect on the motor symptoms. Those two last fMRI will allow the investigators to compare the effect of the introduction of the treatment on the motor symptoms, known to not improve correctly at this stage, and on non-motor symptoms (visual processing deficits in this project) from which no information are available to the investigators knowledge.
- Conditions
- Parkinson's Disease
- Being tested
- fMRI, Ophthalmologic evaluation, visual psychophysics test
- Keywords
- Parkinson's disease, Non-motor symptoms, Visual deficits, Superior colliculus, fMRI
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIOther
The investigators will use a non invasive fMRI technique centred on the superior colliculus during the presentation of flickered check-boards with varying contrast (1, 3, 5 and 9 %).
Ophthalmologic evaluationOther
The aim of this experiment is the evaluate the functional state of a visual structure. Therefore, with this ophthalmologic test, the investigators will control if the participant does not present major visual deficits. This examination will evaluate the visual acuity and the visual field. A funduscopic examination will also be performed to check the retina.
visual psychophysics testOther
This test will allow to control the sensitivity of the participant to our contrast. The participant will be asked to look at screen on which three static check-boards will be presented. The participant will have to choose the two check-boards with the closest contrast.
| Study group | Role | What they receive |
|---|---|---|
| de novo Parkinson's patients | This group includes de novo Parkinson's patients who have just been diagnosed and not started their treatment at the inclusion.
This group will perform three fMRI sessions at different crucial steps of their normal follow up with a neurologist. Their visual abilities will be tested with an ophthalmologic evaluation and their sensitivity to contrast with a visual psycho-physics test. Receives: Other: fMRI; Other: Ophthalmologic evaluation; Other: visual psychophysics test | |
| matching controls | This group includes age-matching control participants to the first Parkinson group.
This group will perform one fMRI session. Their visual abilities will be tested with an ophthalmologic evaluation and their sensitivity to contrast with a visual psycho-physics test. Receives: Other: fMRI; Other: Ophthalmologic evaluation; Other: visual psychophysics test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Light responses measure in the superior colliculus
Measured: 2 hours / session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study start7 Oct 2015
- Primary completionJan 2018
- Study completion19 Jan 2018
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 Parkinson's 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
- 23 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Elena Moro, MD/PhD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, FranceMichel Dojat, PhD, Study chair, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488395
- Sponsor's protocol ID
- C14-58
- Other IDs
- IDRCB
- Acronym
- AGIRPARK
- Status last verified
- Aug 2021
- First submitted
- 26 Jun 2015
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Bellot E, Kauffmann L, Coizet V, Meoni S, Moro E, Dojat M. Effective connectivity in subcortical visual structures in de novo Patients with Parkinson's Disease. Neuroimage Clin. 2022;33:102906. doi: 10.1016/j.nicl.2021.102906. Epub 2021 Dec 7.
PubMed 34891045Moro E, Bellot E, Meoni S, Pelissier P, Hera R, Dojat M, Coizet V; Superior Colliculus Study Group. Visual Dysfunction of the Superior Colliculus in De Novo Parkinsonian Patients. Ann Neurol. 2020 Apr;87(4):533-546. doi: 10.1002/ana.25696. Epub 2020 Feb 19.
PubMed 32030799
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superior Colliculus Activity in Parkinson Disease: a Potential Marker? fMRI Brain Activation in Response to Visual Stimuli.
- ClinicalTrials.gov ID
- NCT02488395
- Acronym / sponsor ID
- AGIRPARK / C14-58
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Non-motor symptoms, Visual deficits, Superior colliculus, fMRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 7 Oct 2015 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- 19 Jan 2018 (actual)
- First posted
- 2 Jul 2015 (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.
The ultimate goal of this project is to evaluate a possible new strategy to diagnose earlier Parkinson's disease, using the superior colliculus as a biomarker.
Preliminary data from the investigator's group in a rat model of Parkinson's disease suggest that the superior colliculus, a sensory structure, show an early deficit in visual processing. The investigator's data also suggests that with the evolution of the disease, this structure presents a neuronal re-organisation leading which causes a sensory rebound after the introduction of the treatment. The light responses in the superior colliculus were faster, bigger in amplitude and lasted longer (Rolland et al., 2012). Those results raise an important question about the superior colliculus functional state in Parkinson's patients. If this structure have a similar neuroplasticity, the investigators could hypothesize that the superior colliculus may also present a sensory rebound when introducing the treatment. If this hypothesis is true, the accelerated and amplified light responses of this structure may explain the difficulties felt by the patients to inhibit reflexive saccades induced by the appearance of unexpected visual stimuli. Indeed, the superior colliculus is involved in the orientation of the head and eye toward any sudden changes in our environment (Wurtz and Albano, 1980) and the light responses of this structure are strongly correlated with the speed of the saccade (Marino et al., 2012).
Therefore, the investigators want to test if a similar deficit could be observed in the superior colliculus of newly diagnosed PD patients. Data will be compared to matching controls.
Detailed description
This project aims at better understanding the physiopathology of Parkinson's disease and the effect of the administration of the classical medical treatment. The main aim of this project is to evaluate the possibility of an early detection using a new original strategy. The investigators want to demonstrate the predictive value of the superior colliculus light responses as an early biomarker.
The investigators will perform functional magnetic resonance imagery (fMRI) to measure the BOLD light responses of the superior colliculus at different key stages of the normal medical follow up of Parkinson's patients by the neurologist (when diagnosed, when introducing the first treatment and when the treatment is stabilised).
Two groups of participants will be tested: a) a group of de novo patients, which have just been diagnosed and haven't started their treatment; b) a group of matching controls.
A first fMRI session (S1) will be performed to compare the light induced BOLD response of the superior colliculus between de novo patients and their matching controls. This session will evaluate a possible visual processing dysfunction in the superior colliculus of newly diagnosed patients.
Parkinson's patients will then start their treatment and a second session (S2) will be done on this group shortly after the introduction of the treatment to measure its acute effect. If the superior colliculus of those patients presents a sensory rebound, the investigators should observe a bigger light-induced BOLD response after the treatment compared to before the treatment.
A third session (S3) will be performed after the optimal adjustment of the treatment on motor symptoms which would be around six month after the start of the treatment. This adjustment is long and difficult, realized by the neurologist according to its effect on the motor symptoms. Those two last fMRI will allow the investigators to compare the effect of the introduction of the treatment on the motor symptoms, known to not improve correctly at this stage, and on non-motor symptoms (visual processing deficits in this project) from which no information are available to the investigators knowledge.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| de novo Parkinson's patients | – | Other: fMRI, Other: Ophthalmologic evaluation, Other: visual psychophysics testThis group includes de novo Parkinson's patients who have just been diagnosed and not started their treatment at the inclusion. This group will perform three fMRI sessions at different crucial steps of their normal follow up with a neurologist. Their visual abilities will be tested with an ophthalmologic evaluation and their sensitivity to contrast with a visual psycho-physics test. |
| matching controls | – | Other: fMRI, Other: Ophthalmologic evaluation, Other: visual psychophysics testThis group includes age-matching control participants to the first Parkinson group. This group will perform one fMRI session. Their visual abilities will be tested with an ophthalmologic evaluation and their sensitivity to contrast with a visual psycho-physics test. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Groups of de novo Parkinson's patients and their age matching controls.
Key inclusion criteria (7 listed)
- De novo parkinson's patients being just diagnosed (stage 1 according to the Hoehn and Yahr scale: first unilateral signs with no discomfort in everyday life) without a current dopaminergic treatment and who have not started their anti-parkinsonian treatment.
- Both Parkinson's patients and their age matching control must not present a major visual pathology (mainly in the retina) which may interfere with the visual task.
- Signed informed and free consent.
- Matching controls must not present a neurological or psychiatric troubles.
- For the matching controls: There are no contraindication on current treatments apart from those to treat other neurological disease than Parkinson's disease or psychiatric troubles.
Key exclusion criteria (11 listed)
- Parkinson's patients with important tremor limiting the validity of the fMRI acquisition.
- Adult under supervision
- Incapacity to understand the consent explanations.
- Impossibility to participate to the whole experimental protocol.
- No affiliation to a health insurance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRIThe investigators will use a non invasive fMRI technique centred on the superior colliculus during the presentation of flickered check-boards with varying contrast (1, 3, 5 and 9 %). | Other | de novo Parkinson's patients, matching controls |
| Ophthalmologic evaluationThe aim of this experiment is the evaluate the functional state of a visual structure. Therefore, with this ophthalmologic test, the investigators will control if the participant does not present major visual deficits. This examination will evaluate the visual acuity and the visual field. A funduscopic examination will also be performed to check the retina. | Other | de novo Parkinson's patients, matching controls |
| visual psychophysics testThis test will allow to control the sensitivity of the participant to our contrast. The participant will be asked to look at screen on which three static check-boards will be presented. The participant will have to choose the two check-boards with the closest contrast. | Other | de novo Parkinson's patients, matching controls |
Primary outcome
Light responses measure in the superior colliculus
Time frame: 2 hours / session
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 18 Nov 2025.
- Results publication: PubMed 34891045Bellot E, Kauffmann L, Coizet V, Meoni S, Moro E, Dojat M. Effective connectivity in subcortical visual structures in de novo Patients with Parkinson's Disease. Neuroimage Clin. 2022;33:102906. doi: 10.1016/j.nicl.2021.102906. Epub 2021 Dec 7.
- Results publication: PubMed 32030799Moro E, Bellot E, Meoni S, Pelissier P, Hera R, Dojat M, Coizet V; Superior Colliculus Study Group. Visual Dysfunction of the Superior Colliculus in De Novo Parkinsonian Patients. Ann Neurol. 2020 Apr;87(4):533-546. doi: 10.1002/ana.25696. Epub 2020 Feb 19.
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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.
Elena Moro, MD/PhD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
Michel Dojat, PhD study chair
Institut National de la Santé Et de la Recherche Médicale, France
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Institut National de la Santé Et de la Recherche Médicale, France at 3 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 7 inclusion and 11 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 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Light responses measure in the superior colliculus (time frame: 2 hours / session). 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 NCT02488395, 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 18 Nov 2025.