Parkinson's DiseaseNCT03454269
Role of Retina in Mechanisms of Illusions and Visual Hallucinations Observed in Idiopathic Parkinson's Disease
A study testing Optical Coherence Tomography in people with Parkinson's Disease and Visual Hallucinations, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Parkinson's disease is characterized not only by motor symptoms but also by psycho-behavioral symptoms including Visual Hallucinations (VH) and illusions (I), that are generally associated with a severe functional impairment and a bad prognosis for patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson's Disease, Visual Hallucinations
- What is being tested?
- Optical Coherence Tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 8 Mar 2018to 30 Mar 2020
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - patients presenting with a Parkinson's Disease according to UKPDSBB criteria
- Patients affiliated to a health insurance company.
- HV-/IV+ Group : patients presenting illusions criteria according to SCOPA, with no visual hallucinations
- HV+/IV- Group : patients presenting visual hallucinations (SCOPA) without illusions
- HV-/IV- Group : patients without hallucinations or illusions SCOPA)
Who cannot join
- Patients with other neurological diseases than PD.
- Patients with active psychiatric pathologies (psychosis).
- Patients unable to remain sit and still during different ophtalmological exams due to camptocormia and dyskinesias.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 0473751195, placarin@chu-clermontferrand.fr
Ana MARQUES
About this study
Parkinson's disease is characterized not only by motor symptoms but also by psycho-behavioral symptoms including Visual Hallucinations (VH) and illusions (I), that are generally associated with a severe functional impairment and a bad prognosis for patients. Visual Hallucinations are defined by a visual perception without any real objet to perceive, whereas illusions are defined by a wrong perceptions of an object that is really present. In most of studies investigating the pathophysiology of VH in PD, no difference is made between VH and I, however different mechanisms could lead to the emergence of these two phenomenon, with different prognosis.
Investigator hypothesize that illusions could be related to a visual impairment, maybe at the retinal level, known to be impaired in PD, whereas Visual hallucinations would be due to a more widespread impairment affecting higher levels visuo-perceptive and cognitive functions.
Read the detailed description
Parkinson's disease is a neurodegenerative disorder characterized by tremor, rigidity and akinesia, but patients can also present various non-motor symptoms in the course of their illness, including visual hallucinations, delusions or illusions. Visual Hallucinations are false perceptions (no external stimulus is present; generally caused by internal stimulations), whereas illusions are defined by a wrong perception (an external stimulus is always present). Delusions are false believes .The occurrence of hallucinations in PD is of major importance as it has been shown to be associated with an increased risk of cognitive impairment and could lead to nursing home placement and to increased mortality. It is generally believed that delusions/illusions also imply a bad prognosis with time . However recent data suggest that delusions/illusion are not associated with such a poor outcome regarding cognitive functions and mortality compared to hallucinations suggesting different pathological mechanisms and anatomical substrates . Also, a recent study analyzing the neuropsychological correlates of minor hallucinations in PD did not find executive dysfunction to contribute to the onset of minor psychotic phenomena, but was specifically implicated in the progression to well-structured VH.
Thus illusions and minorVH may have a different pathogenesis and a different prognosis compared to complex VH, however studies exploring the structural and functional changes associated with hallucinations in PD have mainly included patients with well-structured VH and moderate to severe cognitive impairment , making it difficult to define early abnormalities associated with minor hallucinations or illusions.
Several hypotheses are proposed regarding the emergence of hallucinations in PD.
- It has been first suggested that hallucinations in PD could be mainly the result of a chronic exposition to dopaminergic therapy . However, the description of hallucination in untreated PD patients goes against that solely explication . Besides, no strong link has been identified between the occurrence of VH and the dosage and duration of dopaminergic treatment . This suggests that Dopaminergic treatment would not directly cause VH but could be a precipiting factor.
- Sleep-wake cycle disturbances have also been reported as risk factors for the occurrence of VH in PD , and particularly the presence of REM Sleep behavior disorders (RBD) . The emergence of VH in PD patients coinciding with daytime episodes of REM sleep may be dream imagery occurring during wake , however this hypothesis is still debated.
- Other risk factors have been associated with VH in PD such as the disease duration, motor symptom severity and mostly cognitive impairment. Indeed, VH occur mainly in PD patients with cognitive decline , but also VH are predictive of dementia . In fact, cognitive impairment in PD patients, and particularly visuoperceptive impairment, would lead to an impaired processing of visual information. Indeed, impaired frontal and parietal cortical activation have been reported in PD patients with VH while being presented visual stimulations, suggesting a diminished answer to external perceptions in posterior cortical areas associated with an increased frontal abnormal activity leading to the emergence of sensorial visual experiences . This shifting visual circuitry from posterior to anterior regions associated with attention process impairment may play a role in the pathophysiology of VH in PD. Thus, the occurrence of Visual Hallucinations in PD Patients appears to be due to a desinhibition of the "top-down" visual stream leading to the emergence of internal mental imagery stocked in memory, and interpreted like visual perceptions coming from the external environment .
- Yet, some evidences also points out to an impaired "bottom-up" processing that could lead to the emergence of VH in PD. Indeed, a dopaminergic denervation and alpha synuclein aggregation have been demonstrated in the retina of PD Patients , even at early stages of the disease . However the functional consequences of such a denervation are still poorly understood , even if impaired contrast discrimination and color vision impairment are widely described in PD . One study has reported an association between retinal impairment, measured with OCT, and VH in PD .
Thus, the emergence of VH and illusions in PD could be due to an inbalance between a hypoactivated "bottom-up" (due to retino-striato-occipital hypoactivation) and a deshinibited "top-down" (mainly frontal) visual stream. However in all these studies, Hallucinations and illusions were not specifically discriminated and investigated in spite of the fact that they could be subtended by different pathophysiological mechanisms and might imply different prognosis for the evolution of the disease.
Investigator hypothesize that illusions, which represent the failure to successfully integrate stimuli that have been physically presented, could be more related to "bottom up" impairment, unlike Hallucinations, which occur where there is perception in the absence of any stimulus and could be more related to a "top down" impairment. Thus, PD patients with illusions (PD-I) might present greater retinal degeneration measured by OCT compared to PD patients with Visual hallucinations (PD-VH) and PD patients without Hallucinations or illusion (PD-nVHI), suggesting a sensorial deprivation underlying these disturbed visual perceptions of reality. Visual Hallucinations that are more elaborated would require a more widespread cognitive disorder, with increased cognitive and visuoperceptive dysfunction.
OBJECTIVE In this study investigator aim to compare PD patients with visual hallucinations (PD-VH), with illusions (PD-I), without Visual hallucinations or illusions (PD-nVHI) regarding retinal degeneration in OCT and cognitive functions (visuoperceptive and attentional functions) in order to determine whether PD-I might show greater retinal degeneration compared to PD-VH, and lesser cognitive impairment.
DESIGN OF STUDY:
Investigator will include 30 PD-VH+, 30 PD-I+, 30 PD-VH-I- among the patients consulting at our center.
During the first visit (Baseline, inclusion visit, 2 hours), each subject will perform a clinical and neurological examination with : • Diagnosis of PD according to UKPDBB criteria.
- The presence of Visual Hallucinations or Illusions will be characterized according to the Psychosensory Hallucination Scale. Illusions will be defined by answering "Yes" to at least one of the "elementary items".
During the second visit (Day 15, one day), each patient will have a neurological, neuropsychological and ophthalmological examination with an evaluation of
- the severity of the disease (Hoehn and Yahr score, Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS))
- the cognitive impairment (Montreal Cognitive Assessment, Evaluation of visuo-perceptive functions and attention)
- the excessive diurnal Somnolence and sleep attacks
- the visual acuity, intraocular pressure, Optical Coherence Tomography (OCT), contrast and colour evaluations.
Circumstances of emergence and distress caused by Hallucinations/illusions was also evaluated by measurement of heart rate variability, electrodermal recording, spy glasses and self-evaluation of Stress.
Finally, each subject will have a Magnetic Resonance Imaging (MRI) acquisition.
- Conditions
- Parkinson's Disease, Visual Hallucinations
- Being tested
- Optical Coherence Tomography
- Keywords
- Parkinson disease, Visual Hallucinations, Illusions, Retina
- Medical subject headings
- Parkinson Disease, Hallucinations, Illusions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence TomographyDiagnostic test
The Optical Coherence Tomography is a painless analysis without contact with the eye. Patients are sitting in front of the machine. Each eye is analyzed. By a laser scanning system, longitudinal sections of the retina are made at the level of the macula and the optic nerve. The device automatically segments the different layers which are then measurable (in microns) by the ophthalmologist (duration of the analysis: 3 minutes).
| Study group | Role | What they receive |
|---|---|---|
| PD patients with visual hallucinations (PD-VH) | Active comparator | PD patients without hallucinations or illusions Receives: Diagnostic Test: Optical Coherence Tomography |
| Patients with illusions (PD-I) | Active comparator | PD patients with Illusions and without hallucinations Receives: Diagnostic Test: Optical Coherence Tomography |
| Patients without visual hallucinations or illusions (PD-nVHI)) | Active comparator | PD patients without Illusions and with hallucinations Receives: Diagnostic Test: Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total and segmental Retinal thickness (in microns) measured with Optical Coherence Tomography
Measurement of different retinal layers using Optical coherence tomography
Measured: at day 15
Secondary outcomes (17)
Characteristics and severity of hallucinations/illusions using Psychosensory Hallucination Scale
Four domains (auditory, visual, olfactory and gustatory, cenesthetic hallucination modalities) are defined with nonoverlapping items
Measured: at baseline
Characteristics and severity of hallucinations/illusions measured using the University of Miami Parkinson's Disease Hallucinations Questionnaire
Measured: at baseline
Cognitive function evaluated by the Montreal Cognitive Assessment
Measured: at day 15
Dementia evaluated by the Mattis Dementia Rating Scale
It generates five subscale scores in the areas of Attention, Initiation-Perseveration, Construction, Conceptualization, and Memory.
Measured: at day 15
Best corrected visual acuity measured by Parinaud scale
Parinaud scale measures the best corrected near visual acuity, the best outcome is P2 and the worth <P24.
Measured: at day 15
Intraocular pressure measured with air pulse tonometer
Measured: at day 15
Contrast sensitivity measured using the Vistech test
Measured: at day 15
Color vision measured using the Test 15 Hue de Farnsworth
Measured: at day 15
Parkinsonian syndrome severity measured with the MDS UPDRS Scale
The full MDS-UPDRS contains questions/evaluations, divided across Part I (Non-Motor Aspects of Experiences of Daily Living), Part II (Motor Aspects of Experiences of Daily Living), Part III (Motor Examination : 33 scores based on 18 items, several with right, left or other body distribution scores), and Part IV (Motor Complications).
Measured: at day 15
Parkinsonian syndrome severity measured by the Hoehn and Yahr score
Measured: at day 15
Sleep quality measured by the Parkinson's Disease Sleep Scale
This scale allows to self-rate and quantify the level of sleep disruption being experienced. It rates 15 items that have 0 to 4 options, 4 is the worth option.
Measured: at day 15
Vigilance measurement and sleep Attack research using the Epworth test
Measured: at day 15
Volume of grey matter area (frontal , parietal, occipital, mesencephalic cortex area ) measured at the time of Magnetic Resonance Imaging
Measured: at day 15
Emergence of Hallucinations/illusions and distress measured by heart rate variability
Measured: at day 15
Emergence of Hallucinations/illusions and distress measured by electro dermal recording
Measured: at day 15
Emergence of Hallucinations/illusions and distress measured by self-evaluation of Stress questionnaire
Measured: at day 15
Emergence of Hallucinations/illusions and distress measured by spy glasses questionnaire
Measured: at day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start8 Mar 2018
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Mar 2020 (estimated)
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's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de France
- Responsible party
- Sponsor
- Investigators
- Ana MARQUES, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454269
- Sponsor's protocol ID
- CHU-380
- Other IDs
- 2017-A02605-18
- Status last verified
- Mar 2019
- First submitted
- 27 Feb 2018
- Last updated
- 13 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Marques A, Beze S, Lambert C, Bonamy L, de Chazeron I, Rieu I, Chiambaretta F, Durif F. Psycho-sensory modalities of visual hallucinations and illusions in Parkinson's disease. Rev Neurol (Paris). 2021 Dec;177(10):1228-1236. doi: 10.1016/j.neurol.2021.04.007. Epub 2021 Jul 5.
PubMed 34238577
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Retina in Mechanisms of Illusions and Visual Hallucinations Observed in Idiopathic Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03454269
- Acronym / sponsor ID
- CHU-380
- Conditions
- Parkinson's Disease, Visual Hallucinations
- Keywords
- Parkinson disease, Visual Hallucinations, Illusions, Retina
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Fondation de France
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Mar 2020 (estimated)
- First posted
- 5 Mar 2018 (actual)
- 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 not only by motor symptoms but also by psycho-behavioral symptoms including Visual Hallucinations (VH) and illusions (I), that are generally associated with a severe functional impairment and a bad prognosis for patients. Visual Hallucinations are defined by a visual perception without any real objet to perceive, whereas illusions are defined by a wrong perceptions of an object that is really present. In most of studies investigating the pathophysiology of VH in PD, no difference is made between VH and I, however different mechanisms could lead to the emergence of these two phenomenon, with different prognosis.
Investigator hypothesize that illusions could be related to a visual impairment, maybe at the retinal level, known to be impaired in PD, whereas Visual hallucinations would be due to a more widespread impairment affecting higher levels visuo-perceptive and cognitive functions.
Detailed description
Parkinson's disease is a neurodegenerative disorder characterized by tremor, rigidity and akinesia, but patients can also present various non-motor symptoms in the course of their illness, including visual hallucinations, delusions or illusions. Visual Hallucinations are false perceptions (no external stimulus is present; generally caused by internal stimulations), whereas illusions are defined by a wrong perception (an external stimulus is always present). Delusions are false believes .The occurrence of hallucinations in PD is of major importance as it has been shown to be associated with an increased risk of cognitive impairment and could lead to nursing home placement and to increased mortality. It is generally believed that delusions/illusions also imply a bad prognosis with time . However recent data suggest that delusions/illusion are not associated with such a poor outcome regarding cognitive functions and mortality compared to hallucinations suggesting different pathological mechanisms and anatomical substrates . Also, a recent study analyzing the neuropsychological correlates of minor hallucinations in PD did not find executive dysfunction to contribute to the onset of minor psychotic phenomena, but was specifically implicated in the progression to well-structured VH.
Thus illusions and minorVH may have a different pathogenesis and a different prognosis compared to complex VH, however studies exploring the structural and functional changes associated with hallucinations in PD have mainly included patients with well-structured VH and moderate to severe cognitive impairment , making it difficult to define early abnormalities associated with minor hallucinations or illusions.
Several hypotheses are proposed regarding the emergence of hallucinations in PD.
- It has been first suggested that hallucinations in PD could be mainly the result of a chronic exposition to dopaminergic therapy . However, the description of hallucination in untreated PD patients goes against that solely explication . Besides, no strong link has been identified between the occurrence of VH and the dosage and duration of dopaminergic treatment . This suggests that Dopaminergic treatment would not directly cause VH but could be a precipiting factor.
- Sleep-wake cycle disturbances have also been reported as risk factors for the occurrence of VH in PD , and particularly the presence of REM Sleep behavior disorders (RBD) . The emergence of VH in PD patients coinciding with daytime episodes of REM sleep may be dream imagery occurring during wake , however this hypothesis is still debated.
- Other risk factors have been associated with VH in PD such as the disease duration, motor symptom severity and mostly cognitive impairment. Indeed, VH occur mainly in PD patients with cognitive decline , but also VH are predictive of dementia . In fact, cognitive impairment in PD patients, and particularly visuoperceptive impairment, would lead to an impaired processing of visual information. Indeed, impaired frontal and parietal cortical activation have been reported in PD patients with VH while being presented visual stimulations, suggesting a diminished answer to external perceptions in posterior cortical areas associated with an increased frontal abnormal activity leading to the emergence of sensorial visual experiences . This shifting visual circuitry from posterior to anterior regions associated with attention process impairment may play a role in the pathophysiology of VH in PD. Thus, the occurrence of Visual Hallucinations in PD Patients appears to be due to a desinhibition of the "top-down" visual stream leading to the emergence of internal mental imagery stocked in memory, and interpreted like visual perceptions coming from the external environment .
- Yet, some evidences also points out to an impaired "bottom-up" processing that could lead to the emergence of VH in PD. Indeed, a dopaminergic denervation and alpha synuclein aggregation have been demonstrated in the retina of PD Patients , even at early stages of the disease . However the functional consequences of such a denervation are still poorly understood , even if impaired contrast discrimination and color vision impairment are widely described in PD . One study has reported an association between retinal impairment, measured with OCT, and VH in PD .
Thus, the emergence of VH and illusions in PD could be due to an inbalance between a hypoactivated "bottom-up" (due to retino-striato-occipital hypoactivation) and a deshinibited "top-down" (mainly frontal) visual stream. However in all these studies, Hallucinations and illusions were not specifically discriminated and investigated in spite of the fact that they could be subtended by different pathophysiological mechanisms and might imply different prognosis for the evolution of the disease.
Investigator hypothesize that illusions, which represent the failure to successfully integrate stimuli that have been physically presented, could be more related to "bottom up" impairment, unlike Hallucinations, which occur where there is perception in the absence of any stimulus and could be more related to a "top down" impairment. Thus, PD patients with illusions (PD-I) might present greater retinal degeneration measured by OCT compared to PD patients with Visual hallucinations (PD-VH) and PD patients without Hallucinations or illusion (PD-nVHI), suggesting a sensorial deprivation underlying these disturbed visual perceptions of reality. Visual Hallucinations that are more elaborated would require a more widespread cognitive disorder, with increased cognitive and visuoperceptive dysfunction.
OBJECTIVE In this study investigator aim to compare PD patients with visual hallucinations (PD-VH), with illusions (PD-I), without Visual hallucinations or illusions (PD-nVHI) regarding retinal degeneration in OCT and cognitive functions (visuoperceptive and attentional functions) in order to determine whether PD-I might show greater retinal degeneration compared to PD-VH, and lesser cognitive impairment.
DESIGN OF STUDY:
Investigator will include 30 PD-VH+, 30 PD-I+, 30 PD-VH-I- among the patients consulting at our center.
During the first visit (Baseline, inclusion visit, 2 hours), each subject will perform a clinical and neurological examination with : • Diagnosis of PD according to UKPDBB criteria.
- The presence of Visual Hallucinations or Illusions will be characterized according to the Psychosensory Hallucination Scale. Illusions will be defined by answering "Yes" to at least one of the "elementary items".
During the second visit (Day 15, one day), each patient will have a neurological, neuropsychological and ophthalmological examination with an evaluation of
- the severity of the disease (Hoehn and Yahr score, Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS))
- the cognitive impairment (Montreal Cognitive Assessment, Evaluation of visuo-perceptive functions and attention)
- the excessive diurnal Somnolence and sleep attacks
- the visual acuity, intraocular pressure, Optical Coherence Tomography (OCT), contrast and colour evaluations.
Circumstances of emergence and distress caused by Hallucinations/illusions was also evaluated by measurement of heart rate variability, electrodermal recording, spy glasses and self-evaluation of Stress.
Finally, each subject will have a Magnetic Resonance Imaging (MRI) acquisition.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PD patients with visual hallucinations (PD-VH) | Active comparator | Diagnostic Test: Optical Coherence TomographyPD patients without hallucinations or illusions |
| Patients with illusions (PD-I) | Active comparator | Diagnostic Test: Optical Coherence TomographyPD patients with Illusions and without hallucinations |
| Patients without visual hallucinations or illusions (PD-nVHI)) | Active comparator | Diagnostic Test: Optical Coherence TomographyPD patients without Illusions and with hallucinations |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- - patients presenting with a Parkinson's Disease according to UKPDSBB criteria
- Patients affiliated to a health insurance company.
- HV-/IV+ Group : patients presenting illusions criteria according to SCOPA, with no visual hallucinations
- HV+/IV- Group : patients presenting visual hallucinations (SCOPA) without illusions
- HV-/IV- Group : patients without hallucinations or illusions SCOPA)
Key exclusion criteria (3 listed)
- Patients with other neurological diseases than PD.
- Patients with active psychiatric pathologies (psychosis).
- Patients unable to remain sit and still during different ophtalmological exams due to camptocormia and dyskinesias.
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 |
|---|---|---|
| Optical Coherence TomographyThe Optical Coherence Tomography is a painless analysis without contact with the eye. Patients are sitting in front of the machine. Each eye is analyzed. By a laser scanning system, longitudinal sections of the retina are made at the level of the macula and the optic nerve. The device automatically segments the different layers which are then measurable (in microns) by the ophthalmologist (duration of the analysis: 3 minutes). | Diagnostic test | PD patients with visual hallucinations (PD-VH), Patients with illusions (PD-I), Patients without visual hallucinations or illusions (PD-nVHI)) |
Primary outcome
Total and segmental Retinal thickness (in microns) measured with Optical Coherence Tomography
Time frame: at day 15
Measurement of different retinal layers using Optical coherence tomography
17 secondary outcomes
Characteristics and severity of hallucinations/illusions using Psychosensory Hallucination Scale
Time frame: at baseline
Characteristics and severity of hallucinations/illusions measured using the University of Miami Parkinson's Disease Hallucinations Questionnaire
Time frame: at baseline
Cognitive function evaluated by the Montreal Cognitive Assessment
Time frame: at day 15
Dementia evaluated by the Mattis Dementia Rating Scale
Time frame: at day 15
Best corrected visual acuity measured by Parinaud scale
Time frame: at day 15
Intraocular pressure measured with air pulse tonometer
Time frame: at day 15
Contrast sensitivity measured using the Vistech test
Time frame: at day 15
Color vision measured using the Test 15 Hue de Farnsworth
Time frame: at day 15
Parkinsonian syndrome severity measured with the MDS UPDRS Scale
Time frame: at day 15
Parkinsonian syndrome severity measured by the Hoehn and Yahr score
Time frame: at day 15
Sleep quality measured by the Parkinson's Disease Sleep Scale
Time frame: at day 15
Vigilance measurement and sleep Attack research using the Epworth test
Time frame: at day 15
Volume of grey matter area (frontal , parietal, occipital, mesencephalic cortex area ) measured at the time of Magnetic Resonance Imaging
Time frame: at day 15
Emergence of Hallucinations/illusions and distress measured by heart rate variability
Time frame: at day 15
Emergence of Hallucinations/illusions and distress measured by electro dermal recording
Time frame: at day 15
Emergence of Hallucinations/illusions and distress measured by self-evaluation of Stress questionnaire
Time frame: at day 15
Emergence of Hallucinations/illusions and distress measured by spy glasses questionnaire
Time frame: at day 15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Derived from this study: PubMed 34238577Marques A, Beze S, Lambert C, Bonamy L, de Chazeron I, Rieu I, Chiambaretta F, Durif F. Psycho-sensory modalities of visual hallucinations and illusions in Parkinson's disease. Rev Neurol (Paris). 2021 Dec;177(10):1228-1236. doi: 10.1016/j.neurol.2021.04.007. Epub 2021 Jul 5.
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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.
Ana MARQUES principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical Coherence Tomography in people with Parkinson's Disease and Visual Hallucinations, run by University Hospital, Clermont-Ferrand 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 3 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: status not confirmed, as of the sponsor's last update on 13 Mar 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (0473754963, drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total and segmental Retinal thickness (in microns) measured with Optical Coherence Tomography (time frame: at day 15). 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 NCT03454269, 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 13 Mar 2019.