Clinical trial NCT04731246: Video-oculography and Parkinson's Disease
Official title: Video-oculography and Parkinson's Disease: A Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease, Idiopathic
Keywords: Parkinson's disease
Video-oculography
Oculomotor disorders
Oculomotricity
Neuropsychological evaluations
Movement disorder
Motor disorders
Non-motor fluctuations
Lead sponsor: Association de Recherche Bibliographique pour les Neurosciences
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Princesse Grace
name: Centre Hospitalier Universitaire de Nice
First posted: 2021-01-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, descriptive, interventional, monocentric study. Participants perform an annual evaluation, which combine neurological and neuropsychological evaluations and a video-oculography examination.

Follow-up is carried out over 7 years.
Primary purpose: OTHER

Brief summary: This study aims to study, in patient with Parkinson's disease, mild to moderate stage (according to Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease, Postuma et al., 2015):

* the evolution of oculomotricity markers over time.
* the correlation between neurological evaluations (motor and non-motor scores), neuropsychological evaluations (cognitive disorders) and oculomotricity evaluation, over a follow-up period of 7 years.
* the impact of antiparkinsonian drugs on the evolution of oculomotricity assessment by video-oculography.
* the value of oculomotricity assessment by video-oculography as an evolutionary marker of the disease.


Eligibility criteria: \*Inclusion Criteria:

1. Male or Female;
2. Clinically defined idiopathic Parkinson's Disease (PD);
3. Brain MRI performed in routine care in the 12 months preceding inclusion;
4. Cerebral DaTSCAN or cerebral PET with F-DOPA, performed as routine care before inclusion (no time limit), confirming presynaptic dopaminergic denervation;
5. Hoehn \& Yahr score: 1 to 3;
6. Normal clinical examination of oculomotricity (slight impairment of smooth pursuit accepted);
7. Neuro-cognitive disorders: absent or minor (according to DSM5);
8. Sufficient written and oral expression in French;
9. Covered by a health insurance system;
10. Written informed consent signed by the patient;
11. Presence of a caregiver.

    \* Exclusion Criteria:
12. Psychiatric comorbidity (except anxiety or mild to moderate depression);
13. Neurological comorbidity, if significant;
14. Brain MRI showing:

    1. significant cerebrovascular pathology (Fazekas I admitted),
    2. another brain disease, including stroke.
15. Major cognitive impairment;
16. Absolute exclusion criteria and "Red flags" of the 2015 criteria orienting towards another degenerative pathology of the extrapyramidal system:

    * Cerebellar syndrome
    * Vertical oculomotricity disorders on clinical examination
    * Motor symptoms restricted to the lower limbs
    * Bilateral and perfectly symmetrical parkinsonism
    * Early dystonia
    * Clinical profile suggestive of behavioral variant frontotemporal dementia (bvFTD)
    * Progressive aphasia or apraxia
    * Moderate or severe postural instability and / or early falls
    * Early bulbar dysfunction (dysarthria, swallowing disorders)
    * Ventilatory dysfunction (inspiration)
    * Severe dysautonomia
    * DOPA-resistance
    * Neuroleptic treatment or related
17. Normal MIBG myocardial scintigraphy (if performed).

Primary outcomes:
measure: Change from Baseline of Oculomotor raw performance at 7 years - Latency in Horizontal saccades.
timeFrame: Baseline; Year 7
measure: Change from Baseline of Oculomotor raw performance at 7 years - Main velocity in Horizontal saccades.
timeFrame: Baseline; Year 7
measure: Change from Baseline of Oculomotor raw performance at 7 years - Gain in Horizontal saccades.
timeFrame: Baseline; Year 7
measure: Change from Baseline of Oculomotor raw performance at 7 years - Latency in Vertical saccades.
timeFrame: Baseline; Year 7
measure: Change from Baseline of Oculomotor raw performance at 7 years - Main velocity in Vertical saccades.
timeFrame: Baseline; Year 7
measure: Change from Baseline of Oculomotor raw performance at 7 years - Gain in Vertical saccades.
timeFrame: Baseline; Year 7
measure: Change from Baseline of Inhibition capacity at 7 years
timeFrame: Baseline; Year 7
measure: Change from Baseline of Internuclear ophthalmoplegia (INO) detection at 7 years
timeFrame: Baseline; Year 7
measure: Change from Baseline of Fixations impairments detection at 7 years
timeFrame: Baseline; Year 7
Secondary outcomes:
measure: Patients description
timeFrame: Baseline
measure: Treatments of Parkinson's disease
timeFrame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
measure: Evolution of Oculomotor raw performance - Latency in Horizontal saccades
timeFrame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
measure: Evolution of Oculomotor raw performance - Main velocity in Horizontal saccades.
timeFrame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
measure: Evolution of Oculomotor raw performance - Gain in Horizontal saccades.
timeFrame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
measure: Evolution of Oculomotor raw performance - Latency in Vertical saccades
timeFrame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
measure: Evolution of Oculomotor raw performance - Main velocity in Vertical saccades
timeFrame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
measure: Evolution of Oculomotor raw performance - Gain in Vertical saccades
timeFrame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
measure: Inhibition capacity
timeFrame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
measure: Internuclear ophthalmoplegia (INO) detection
timeFrame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
measure: Fixations impairments detection
timeFrame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
measure: Neurological evaluation - evolution of motor disorders
timeFrame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
measure: Neurological evaluation - Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
timeFrame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
measure: Neurological evaluation - Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV
timeFrame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
measure: Neurological evaluation - Movement Disorder Society Non-Motor rating Scale (MDS-NMS)
timeFrame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
measure: Neurological evaluation - Movement Disorder Society Non-Motor rating Scale (MDS-NMS) Non-Motor Fluctuations (NMF)
timeFrame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
measure: Orthostatic hypotension
timeFrame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
measure: MRI scan
timeFrame: Baseline; Year 3; Year 7
measure: DAT scan
timeFrame: Baseline; Year 3; Year 7
measure: PET/CT scan
timeFrame: Baseline; Year 3; Year 7
measure: MIBG myocardial scintigraphy
timeFrame: Baseline; Year 3; Year 7
measure: Mini Mental State (MMSE)
timeFrame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
measure: Evolution of general cognitive behavior
timeFrame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
measure: Episodic memory performance
timeFrame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
measure: Executive performance - T.M.T
timeFrame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
measure: Executive performance - Stroop test
timeFrame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
measure: Executive performance - B.R.E.F.
timeFrame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
measure: Verbal fluency
timeFrame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
measure: Visuospatial function
timeFrame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
measure: Visuospatial/constructional ability
timeFrame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
measure: Praxis assessment
timeFrame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
measure: Social cognition and Emotional assessment
timeFrame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
Other outcomes:
Locations:
city: Monaco
country: Monaco
facility: Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital
Study officials:
affiliation: Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital, Monaco.
name: Philippe BARRES, MD
role: STUDY_DIRECTOR
affiliation: Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital, Monaco
name: Sandrine LOUCHART DE LA CHAPELLE, MD-PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: AREBISN (Association de Recherche Bibliographique pour les Neurosciences), Nice (France)
name: Alain PESCE, PUPH
role: STUDY_CHAIR
affiliation: Centre Expert Parkinson, Unités des Pathologies du Mouvement, Hôpital Pasteur 2, Nice (France)
name: Caroline GIORDANA, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Médecine Nucléaire, Princess Grace Hospital, Monaco.
name: Benoit PAULMIER, MD
role: PRINCIPAL_INVESTIGATOR
References: