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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 September 2021 |
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Main ID: |
NCT02488395 |
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Date of registration:
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26/06/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Superior Colliculus Activity in Parkinson Disease: a Potential Marker?
AGIRPARK |
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Scientific title:
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Superior Colliculus Activity in Parkinson Disease: a Potential Marker? fMRI Brain Activation in Response to Visual Stimuli. |
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Date of first enrolment:
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October 7, 2015 |
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Target sample size:
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23 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02488395 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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France
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Contacts
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Name:
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Michel Dojat, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut National de la Santé Et de la Recherche Médicale, France |
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Name:
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Elena Moro, MD/PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut National de la Santé Et de la Recherche Médicale, France |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Exclusion Criteria specific for MRI:
- Pacemaker, neurosensorial stimulator or implanted defibrillator.
- Presence of ocular or cerebral ferromagnetic material.
- Respiratory disease (i.e. asthma), cardio-vascular deficits, claustrophobia
Age minimum:
35 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Other: Ophthalmologic evaluation
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Other: fMRI
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Other: visual psychophysics test
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Primary Outcome(s)
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Light responses measure in the superior colliculus
[Time Frame: 2 hours / session]
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Secondary ID(s)
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IDRCB
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C14-58
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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