Parkinson Disease3DparksNCT01620164
Assessment of Three-dimensional Vision Alteration in Parkinson Disease
A study testing Psychophysical measurements of 3D perception in people with Parkinson Disease, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Psychophysical measurements of 3D perception
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2011to Jun 2014
- Phase
- Interventional
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Three-dimensional Vision Alteration in Parkinson Disease.
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Psychophysical measurements of 3D perception
- Keywords
- three-dimensional vision, Parkinson
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychophysical measurements of 3D perceptionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Parkinsonian patients OFF/ON | Other | 9 patients will be evaluated with psychophysical measurements of 3D perception, in OFF then ON conditions Receives: Other: Psychophysical measurements of 3D perception |
| healthy subjects | Other | Healthy subjects will be evaluated with psychophysical measurements of 3D perception, without treatment Receives: Other: Psychophysical measurements of 3D perception |
| Parkinsonian patients ON/OFF | Other | 9 patients will be evaluated with psychophysical measurements of 3D perception, in ON and then OFF conditions Receives: Other: Psychophysical measurements of 3D perception |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
before and after levodopa intake for PD patients and once for healthy volunteers
Measured: 12 hours after levodopa intake
assessment of 3D psychophysical performance of parkinsonian patients in both ON and OFF L Dopa conditions
before and after levodopa intake for PD patients
Measured: 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
before and after levodopa intake for PD patients
Measured: 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
before and after levodopa intake for PD patients
Measured: 12 hours after levodopa intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startNov 2011
- Primary completionNov 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabienne Ory-Magne, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620164
- Sponsor's protocol ID
- 1015102
- Other IDs
- AOL 2010
- Acronym
- 3Dparks
- Status last verified
- May 2017
- First submitted
- 7 Nov 2011
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28327351
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Three-dimensional Vision Alteration in Parkinson Disease.
- ClinicalTrials.gov ID
- NCT01620164
- Acronym / sponsor ID
- 3Dparks / 1015102
- Conditions
- Parkinson Disease
- Keywords
- three-dimensional vision, Parkinson
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 15 Jun 2012 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parkinsonian patients OFF/ON | Other | Other: Psychophysical measurements of 3D perception9 patients will be evaluated with psychophysical measurements of 3D perception, in OFF then ON conditions |
| healthy subjects | Other | Other: Psychophysical measurements of 3D perceptionHealthy subjects will be evaluated with psychophysical measurements of 3D perception, without treatment |
| Parkinsonian patients ON/OFF | Other | Other: Psychophysical measurements of 3D perception9 patients will be evaluated with psychophysical measurements of 3D perception, in ON and then OFF conditions |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Psychophysical measurements of 3D perception3D 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. | Other | Parkinsonian patients OFF/ON, Parkinsonian patients ON/OFF, healthy subjects |
Primary outcome
performance (in percent error) in a 2D/3D categorization task of both parkinsonian patients (OFF treatment) and control subjects.
Time frame: 12 hours after levodopa intake
before and after levodopa intake for PD patients and once for healthy volunteers
4 secondary outcomes
measure of early visual evoked potentials components latency, recorded in parkinsonian patients, in ON and OFF L Dopa conditions, and in control subjects
Time frame: 12 hours after levodopa intake
assessment of 3D psychophysical performance of parkinsonian patients in both ON and OFF L Dopa conditions
Time frame: 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
Time frame: 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
Time frame: 12 hours after levodopa intake
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 12 May 2017.
- Results publication: PubMed 28327351Severac 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.
Related trials for Parkinson Disease
Active, not recruitingPhase 3
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
Carcinoma, Renal Cell
Not yet recruiting
The Effects of Ischemic Conditioning in Individuals With Parkinson's Disease
Parkinson Disease
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Active, not recruitingPhase 2
A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)
Carcinoma, Non-Small-Cell Lung
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
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.
Fabienne Ory-Magne, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychophysical measurements of 3D perception in people with Parkinson Disease, run by University Hospital, Toulouse at 1 site 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 5 inclusion and 5 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 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
performance (in percent error) in a 2D/3D categorization task of both parkinsonian patients (OFF treatment) and control subjects. (time frame: 12 hours after levodopa intake). 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 NCT01620164, which also lists 1 linked publication.
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 12 May 2017; AzTrials last refreshed its copy on 7 Nov 2026.