Role of Retina in Mechanisms of Illusions and Visual Hallucinations Observed in Idiopathic Parkinson's Disease

NCT03454269 | Unknown

• 2 other identifiers: CHU-3802017-A02605-18
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Parkinson's Disease; Visual Hallucinations

Keywords

Parkinson disease; Visual Hallucinations; Illusions; Retina

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Characteristics and severity of hallucinations/illusions using Psychosensory Hallucination Scale

  at baseline

• Characteristics and severity of hallucinations/illusions measured using the University of Miami Parkinson's Disease Hallucinations Questionnaire

  at baseline

• Cognitive function evaluated by the Montreal Cognitive Assessment

  at day 15

• Dementia evaluated by the Mattis Dementia Rating Scale

  at day 15

• Best corrected visual acuity measured by Parinaud scale

  at day 15

Study Arms (3)

PD patients with visual hallucinations (PD-VH)

ACTIVE COMPARATOR

PD patients without hallucinations or illusions

Diagnostic Test: Optical Coherence Tomography

Patients with illusions (PD-I)

ACTIVE COMPARATOR

PD patients with Illusions and without hallucinations

Diagnostic Test: Optical Coherence Tomography

Patients without visual hallucinations or illusions (PD-nVHI))

ACTIVE COMPARATOR

PD patients without Illusions and with hallucinations

Diagnostic Test: Optical Coherence Tomography

Interventions

Optical Coherence Tomography DIAGNOSTIC_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).

PD patients with visual hallucinations (PD-VH); Patients with illusions (PD-I); Patients without visual hallucinations or illusions (PD-nVHI))

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Fondation de France: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 34238577 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Hallucinations; Illusions

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Ana MARQUES

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

0473754963; drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 5, 2018
• Study Start: March 8, 2018
• Primary Completion: September 30, 2019
• Study Completion: March 30, 2020
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

FR (1)