Parkinson's Disease Clinical Trial
Official title:
Role of Retina in Mechanisms of Illusions and Visual Hallucinations Observed in Idiopathic Parkinson's Disease
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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | March 30, 2020 |
Est. primary completion date | September 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - - 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) Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
France | CHU Clermont-Ferrand | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand | Fondation de France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total and segmental Retinal thickness (in microns) measured with Optical Coherence Tomography | Measurement of different retinal layers using Optical coherence tomography | at day 15 | |
Secondary | 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 | at baseline | |
Secondary | Characteristics and severity of hallucinations/illusions measured using the University of Miami Parkinson's Disease Hallucinations Questionnaire | at baseline | ||
Secondary | Cognitive function evaluated by the Montreal Cognitive Assessment | at day 15 | ||
Secondary | Dementia evaluated by the Mattis Dementia Rating Scale | It generates five subscale scores in the areas of Attention, Initiation-Perseveration, Construction, Conceptualization, and Memory. | at day 15 | |
Secondary | 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 at day 15 |
| |
Secondary | Intraocular pressure measured with air pulse tonometer | at day 15 | ||
Secondary | Contrast sensitivity measured using the Vistech test | at day 15 | ||
Secondary | Color vision measured using the Test 15 Hue de Farnsworth | at day 15 | ||
Secondary | 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). | at day 15 | |
Secondary | Parkinsonian syndrome severity measured by the Hoehn and Yahr score | at day 15 | ||
Secondary | 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. | at day 15 | |
Secondary | Vigilance measurement and sleep Attack research using the Epworth test | at day 15 | ||
Secondary | Volume of grey matter area (frontal , parietal, occipital, mesencephalic cortex area ) measured at the time of Magnetic Resonance Imaging | at day 15 | ||
Secondary | Emergence of Hallucinations/illusions and distress measured by heart rate variability | at day 15 | ||
Secondary | Emergence of Hallucinations/illusions and distress measured by electro dermal recording | at day 15 | ||
Secondary | Emergence of Hallucinations/illusions and distress measured by self-evaluation of Stress questionnaire | at day 15 | ||
Secondary | Emergence of Hallucinations/illusions and distress measured by spy glasses questionnaire | at day 15 |
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