NCT02488395

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2015

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 2, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

October 7, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2018

Completed
Last Updated

November 18, 2025

Status Verified

August 1, 2021

Enrollment Period

2.2 years

First QC Date

June 26, 2015

Last Update Submit

November 14, 2025

Conditions

Keywords

Parkinson's diseaseNon-motor symptomsVisual deficitsSuperior colliculusfMRI

Outcome Measures

Primary Outcomes (1)

  • Light responses measure in the superior colliculus

    2 hours / session

Study Arms (2)

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.

Other: fMRIOther: Ophthalmologic evaluationOther: 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.

Other: fMRIOther: Ophthalmologic evaluationOther: visual psychophysics test

Interventions

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 %).

de novo Parkinson's patientsmatching controls

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.

de novo Parkinson's patientsmatching controls

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.

de novo Parkinson's patientsmatching controls

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Groups of de novo Parkinson's patients and their age matching controls.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU de Grenoble

Grenoble, Isere, 38000, France

Location

Grenoble Institute of Neurosciences

Grenoble, Isere, 38000, France

Location

IRMAGE

Grenoble, Isere, 38000, France

Location

Related Publications (2)

  • 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.

  • Moro 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.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Elena Moro, MD/PhD

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

    PRINCIPAL INVESTIGATOR
  • Michel Dojat, PhD

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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2015

First Posted

July 2, 2015

Study Start

October 7, 2015

Primary Completion

January 1, 2018

Study Completion

January 19, 2018

Last Updated

November 18, 2025

Record last verified: 2021-08

Locations