Video-oculography and Parkinson's Disease

NCT04731246 | Recruiting

• 1 other identifier: EYE-PD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease, Idiopathic

Keywords

Parkinson's disease; Video-oculography; Oculomotor disorders; Oculomotricity; Neuropsychological evaluations; Movement disorder; Motor disorders; Non-motor fluctuations

Outcome Measures

Primary Outcomes (9)

• Change from Baseline of Oculomotor raw performance at 7 years - Latency in Horizontal saccades.

  This concerns saccades Latency (in ms) during horizontal paradigms. Eye movements were recorded and analyzed with an eye-tracking device. For each subject value were judged abnormal if they differed by \>1.65 SD compared to their reference sample.

  Baseline; Year 7

• Change from Baseline of Oculomotor raw performance at 7 years - Main velocity in Horizontal saccades.

  This concerns saccades Main velocity (in °/sec) during horizontal paradigms. Eye movements were recorded and analyzed with an eye-tracking device. For each subject value were judged abnormal if they differed by \>1.65 SD compared to their reference sample.

  Baseline; Year 7

• Change from Baseline of Oculomotor raw performance at 7 years - Gain in Horizontal saccades.

  This concerns saccades Gain (gaze accuracy) during horizontal paradigms. Eye movements were recorded and analyzed with an eye-tracking device. For each subject value were judged abnormal if they differed by \>1.65 SD compared to their reference sample.

  Baseline; Year 7

• Change from Baseline of Oculomotor raw performance at 7 years - Latency in Vertical saccades.

  This concerns saccades Latency (in ms) during vertical paradigms. Eye movements were recorded and analyzed with an eye-tracking device. For each subject value were judged abnormal if they differed by \>1.65 SD compared to their reference sample.

  Baseline; Year 7

• Change from Baseline of Oculomotor raw performance at 7 years - Main velocity in Vertical saccades.

  This concerns saccades Main velocity (in °/sec) during vertical paradigms. Eye movements were recorded and analyzed with an eye-tracking device. For each subject value were judged abnormal if they differed by \>1.65 SD compared to their reference sample.

  Baseline; Year 7

• Change from Baseline of Oculomotor raw performance at 7 years - Gain in Vertical saccades.

  This concerns saccades Gain (gaze accuracy) during vertical paradigms. Eye movements were recorded and analyzed with an eye-tracking device. For each subject value were judged abnormal if they differed by \>1.65 SD compared to their reference sample.

  Baseline; Year 7

• Change from Baseline of Inhibition capacity at 7 years

  Measure of inhibition capacity performance during an "antisaccades" paradigm. Eye movements were recorded and analyzed with an eye-tracking device. Evaluation criteria: percentage of errors. For each subject value were judged abnormal if they differed by \>1.65 SD compared to their reference sample.

  Baseline; Year 7

• Change from Baseline of Internuclear ophthalmoplegia (INO) detection at 7 years

  Highlight presence/absence of INO. Eye movements were recorded and analyzed with an eye-tracking device. Evaluation criteria: INO is present if calculated ratio of abducting to adducting eye movement (both mean and peak velocity) is \>1.

  Baseline; Year 7

• Change from Baseline of Fixations impairments detection at 7 years

  Highlight presence/absence of Fixations impairments. Eye movements were recorded and analyzed with an eye-tracking device. Evaluation criteria: presence/absence/frequency of square wave-jerks, nystagmus, flutters.

  Baseline; Year 7

Secondary Outcomes (32)

• Patients description

  Baseline

• Treatments of Parkinson's disease

  Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable

• Evolution of Oculomotor raw performance - Latency in Horizontal saccades

  Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable

• Evolution of Oculomotor raw performance - Main velocity in Horizontal saccades.

  Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable

• Evolution of Oculomotor raw performance - Gain in Horizontal saccades.

  Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable

Study Arms (1)

Parkinson's disease (mild to moderate stage)

EXPERIMENTAL

Other: Video-oculography / Neuropsychological evaluations

Interventions

Video-oculography / Neuropsychological evaluations OTHER

Annual evaluation: Medical history; Clinical, Neurological and Neuropsychological evaluations; Video-oculography examination; Inventory of examinations carried out in routine care (brain MRI, cerebral DaTScan, cerebral F-Dopa PET/CT scan, MIBG myocardial scintigraphy, blood test). Follow-up is carried out over 7 years.

Parkinson's disease (mild to moderate stage)

Eligibility Criteria

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

You may qualify if:

• Male or Female;
• Clinically defined idiopathic Parkinson's Disease (PD);
• Hoehn \& Yahr score: 1 to 3;
• Normal clinical examination of oculomotricity (slight impairment of smooth pursuit accepted);
• Neuro-cognitive disorders: absent or minor (according to DSM5);
• Sufficient written and oral expression in French;
• Covered by a health insurance system;
• Written informed consent signed by the patient;
• Presence of a caregiver.

You may not qualify if:

• Psychiatric comorbidity (except anxiety or mild to moderate depression);
• Neurological comorbidity, if significant;
• Brain MRI showing:
• significant cerebrovascular pathology (Fazekas I admitted),
• another brain disease, including stroke.
• Major cognitive impairment;
• 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)

Sponsors & Collaborators

• Association de Recherche Bibliographique pour les Neurosciences: lead
• Centre Hospitalier Princesse Grace: collaborator
• Centre Hospitalier Universitaire de Nice: collaborator

Study Sites (1)

Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital

Monaco, 98000, Monaco

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Movement Disorders; Motor Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases; Mental Disorders

Study Officials

• Philippe BARRES, MD

  Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital, Monaco.

  STUDY DIRECTOR

• Sandrine LOUCHART DE LA CHAPELLE, MD-PHD

  Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital, Monaco

  PRINCIPAL INVESTIGATOR

• Alain PESCE, PUPH

  AREBISN (Association de Recherche Bibliographique pour les Neurosciences), Nice (France)

  STUDY CHAIR

• Caroline GIORDANA, MD

  Centre Expert Parkinson, Unités des Pathologies du Mouvement, Hôpital Pasteur 2, Nice (France)

  PRINCIPAL INVESTIGATOR

• Benoit PAULMIER, MD

  Médecine Nucléaire, Princess Grace Hospital, Monaco.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Solange HESSE

CONTACT

+377 99995599; solange.hesse@chpg.mc

Kévin POLET

CONTACT

kevin.polet@chpg.mc

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 29, 2021
• Study Start: July 7, 2021
• Primary Completion (Estimated): January 1, 2032
• Study Completion (Estimated): January 1, 2032
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)