Assessment of Three-dimensional Vision Alteration in Parkinson Disease (3Dparks)
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Psychophysical measurements of 3D perception
Sponsored by
About this trial
This is an interventional basic science trial for Parkinson Disease focused on measuring three-dimensional vision, Parkinson
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- CHU de Toulouse, Hôpital Purpan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Parkinsonian patients OFF/ON
healthy subjects
Parkinsonian patients ON/OFF
Arm Description
9 patients will be evaluated with psychophysical measurements of 3D perception, in OFF then ON conditions
Healthy subjects will be evaluated with psychophysical measurements of 3D perception, without treatment
9 patients will be evaluated with psychophysical measurements of 3D perception, in ON and then OFF conditions
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
measure of early visual evoked potentials components latency, recorded in parkinsonian patients, in ON and OFF L Dopa conditions, and in control subjects
before and after levodopa intake for PD patients and once for healthy volunteers
assessment of 3D psychophysical performance of parkinsonian patients in both ON and OFF L Dopa conditions
before and after levodopa intake for PD patients
search for correlation between the severity of motor impairment of parkinsonian patients and the percentage of error in categorization tasks
before and after levodopa intake for PD patients
search for correlation between the severity of motor impairment of parkinsonian patients and the increase of early visual evoked potentials components latency
before and after levodopa intake for PD patients
Full Information
NCT ID
NCT01620164
First Posted
November 7, 2011
Last Updated
May 10, 2017
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT01620164
Brief Title
Assessment of Three-dimensional Vision Alteration in Parkinson Disease
Acronym
3Dparks
Official Title
Assessment of Three-dimensional Vision Alteration in Parkinson Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This is a monocentric and prospective study that will compare Parkinsonian patients versus healthy subjects on the execution of psychophysical tests and Visual Evoked Potentials without and with L Dopa. The comparison will focus on one hand between PD patients and control subjects (matched by age and sex to parkinsonian patients) and on the other hand between parkinsonian patients in ON and OFF drug conditions.
Psychophysical measurements of 3D perception will be performed during this study. This will be done by asking the subjects to indicate with a joystick whether they perceived the stimulus presented on the screen placed in front of them like being 2D or 3D. Two "depth conditions" will be tested; 2D for flat stimuli and 3D for in depth stimuli. Two "3D-cues" conditions will be tested: binocular cues (retinal disparity) and monocular cues (perspective). Their performances will be assessed in both L Dopa ON and OFF conditions randomly determined.
While subjects will be performing the psychophysical tasks, we will record the visual potentials evoked by the presentation of the 2D/3D visual stimuli. Visual Evoked Potentials are obtained by extracting from the EEG the electrical signals temporally locked to the visual stimulations.
3D perception is at the intersection of pure visual perception and navigation; indeed, any movement in a familiar or unfamiliar environment requires an adequate balance between the reality of the three-dimensional environing space and its mental representation. So one of the major roles of the visual system is to convert the two-dimensional retinal images into 3 dimensions. With both binocular (retinal disparity, eye vergence) and monocular (perspective, shading ...) cues, the 3D vision can estimate (1) the distance between objects (2) distance between an object and itself, (3) relief or depth of an object. Altering that perception affects the postural and locomotor functions and thus must worsen motor disorders. So far, no systematic studies have been conducted in parkinsonian patients to quantify their 3D perception. Because of the interaction between 3D perception and motor outcomes, we want, in this project, to estimate the 3D visual deficits, to understand the underlying altered processes, to test the effect of L Dopa on these deficits and to specify the relationship between 3D visual and motor deficits.
3D psychophysical performances using a categorization task and their underlying neuronal mechanisms measured with VEP will be assessed in both Parkinsonian patients and control subjects in a randomized and comparative study.
Parkinsonian patients will be hospitalized for less than 48 hours. Patients randomized in order OFF-ON L Dopa condition will arrive at 8 am. They will perform the first part of the experiment in OFF condition. Later they will receive 150% of their usual treatment dose, perform the experiment and leave the hospital. Patients randomized in order ON-OFF will arrive at 8 am to receive 150% of their usual treatment dose and perform the experiment. The following day, they will perform the experiment weaned from any dopaminergic therapy since midnight in OFF condition. They will leave the hospital after receiving their usual treatment dose.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
three-dimensional vision, Parkinson
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parkinsonian patients OFF/ON
Arm Type
Other
Arm Description
9 patients will be evaluated with psychophysical measurements of 3D perception, in OFF then ON conditions
Arm Title
healthy subjects
Arm Type
Other
Arm Description
Healthy subjects will be evaluated with psychophysical measurements of 3D perception, without treatment
Arm Title
Parkinsonian patients ON/OFF
Arm Type
Other
Arm Description
9 patients will be evaluated with psychophysical measurements of 3D perception, in ON and then OFF conditions
Intervention Type
Other
Intervention Name(s)
Psychophysical measurements of 3D perception
Intervention Description
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.
Primary Outcome Measure Information:
Title
performance (in percent error) in a 2D/3D categorization task of both parkinsonian patients (OFF treatment) and control subjects.
Description
before and after levodopa intake for PD patients and once for healthy volunteers
Time Frame
12 hours after levodopa intake
Secondary Outcome Measure Information:
Title
measure of early visual evoked potentials components latency, recorded in parkinsonian patients, in ON and OFF L Dopa conditions, and in control subjects
Description
before and after levodopa intake for PD patients and once for healthy volunteers
Time Frame
12 hours after levodopa intake
Title
assessment of 3D psychophysical performance of parkinsonian patients in both ON and OFF L Dopa conditions
Description
before and after levodopa intake for PD patients
Time Frame
12 hours after levodopa intake
Title
search for correlation between the severity of motor impairment of parkinsonian patients and the percentage of error in categorization tasks
Description
before and after levodopa intake for PD patients
Time Frame
12 hours after levodopa intake
Title
search for correlation between the severity of motor impairment of parkinsonian patients and the increase of early visual evoked potentials components latency
Description
before and after levodopa intake for PD patients
Time Frame
12 hours after levodopa intake
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabienne Ory-Magne, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Toulouse, Hôpital Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
28327351
Citation
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.
Results Reference
result
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Assessment of Three-dimensional Vision Alteration in Parkinson Disease
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