Assessment of Three-dimensional Vision Alteration in Parkinson Disease
3Dparks
2 other identifiers
interventional
36
1 country
1
Brief Summary
Parkinson's disease is characterized by motor deficits, improved by dopaminergic intakes. Besides motor symptoms, visual troubles are observed in patients with Parkinson's disease, in particular spatial orientation problems including 3D vision. However, although these visual disturbances are commonly reported by the patients and their family in our clinical experience, they have not been the subject of specific clinical studies yet. Parkinsonian patients report deficits in 3D vision leading to a loss of visuomotor ability, locomotor functions and to falls. Despite these frequent complaints, little is known about 3D vision in Parkinson's disease. The investigators want in this project to precisely estimate 3D deficits in parkinsonian patients by assessing their psychophysical performances in 3D vision tasks to compare to age matched control subjects' performances.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable parkinson-disease
Started Nov 2011
Typical duration for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 7, 2011
CompletedFirst Posted
Study publicly available on registry
June 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedMay 12, 2017
May 1, 2017
2 years
November 7, 2011
May 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
performance (in percent error) in a 2D/3D categorization task of both parkinsonian patients (OFF treatment) and control subjects.
before and after levodopa intake for PD patients and once for healthy volunteers
12 hours after levodopa intake
Secondary Outcomes (4)
measure of early visual evoked potentials components latency, recorded in parkinsonian patients, in ON and OFF L Dopa conditions, and in control subjects
12 hours after levodopa intake
assessment of 3D psychophysical performance of parkinsonian patients in both ON and OFF L Dopa conditions
12 hours after levodopa intake
search for correlation between the severity of motor impairment of parkinsonian patients and the percentage of error in categorization tasks
12 hours after levodopa intake
search for correlation between the severity of motor impairment of parkinsonian patients and the increase of early visual evoked potentials components latency
12 hours after levodopa intake
Study Arms (3)
Parkinsonian patients OFF/ON
OTHER9 patients will be evaluated with psychophysical measurements of 3D perception, in OFF then ON conditions
healthy subjects
OTHERHealthy subjects will be evaluated with psychophysical measurements of 3D perception, without treatment
Parkinsonian patients ON/OFF
OTHER9 patients will be evaluated with psychophysical measurements of 3D perception, in ON and then OFF conditions
Interventions
3D psychophysical performances using a categorization tasks and their underlying mechanisms measured with visual evoked potentials will be assessed in a randomized and comparative study. The order of psychophysical and visual evoked potentials experiments will be randomized between the L Dopa ON and OFF conditions. The randomization will be done by the clinical investigational center. The comparisons will be made between parkinsonian patient and control subjects, and between parkinsonian patients in L Dopa ON and OFF conditions.
Eligibility Criteria
You may qualify if:
- Patients with idiopathic Parkinson's disease of both sex,
- aged between 50 and 75 with an equivalent corrected vision of minimum 7/10 in both eyes. Patients with vision less than 7/10 in one or both eyes.
- Patients with a normal binocular fusion (Bagolini test).
- Control subjects of both sex,
- \- aged between 50 and 75 with an equivalent corrected vision of minimum 7/10 in both eyes.
You may not qualify if:
- Patients with non idiopathic Parkinson's disease.
- Patients with vision less than 7/10.
- Patients with significant tremor during periods of blocking (OFF) or abnormal involuntary movements (dyskinesia) during periods of release (ON).
- Patients with visual hallucinations.
- Patients with impaired cognitive function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Toulouse, Hôpital Purpan
Toulouse, 31059, France
Related Publications (1)
Severac Cauquil A, Ory-Magne F, Jardine V, Galitzky M, Rosito M, Brefel-Courbon C, Celebrini S. Parkinson's patients can rely on perspective cues to perceive 3D space. Brain Res. 2017 May 15;1663:161-165. doi: 10.1016/j.brainres.2017.03.017. Epub 2017 Mar 19.
PMID: 28327351RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fabienne Ory-Magne, MD
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2011
First Posted
June 15, 2012
Study Start
November 1, 2011
Primary Completion
November 1, 2013
Study Completion
June 1, 2014
Last Updated
May 12, 2017
Record last verified: 2017-05