Video-oculography and Parkinson's Disease

Parkinson Disease, Idiopathic Clinical Trial

Official title:

Video-oculography and Parkinson's Disease: A Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04731246
• Other study ID #: EYE-PD
• Status: Recruiting
• Phase: N/A
• Start date: July 7, 2021
• Est. completion date: January 2032

Study information

• Verified date: March 2023
• Source: Association de Recherche Bibliographique pour les Neurosciences
• Contact: Solange HESSE
• Phone: +377 99995599
• Email: solange.hesse[@]chpg.mc
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2032
• Est. primary completion date: January 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

*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).

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson Disease, Idiopathic

Intervention

Other:
• Video-oculography / Neuropsychological evaluations
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.

Locations

Country	Name	City	State
Monaco	Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital	Monaco

Sponsors (3)

Lead Sponsor	Collaborator
Association de Recherche Bibliographique pour les Neurosciences	Centre Hospitalier Princesse Grace, Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Patients description	Profile description of included patients, based on demographic data and clinical exam (sex, age, Weight, height), inclusion/exclusion criteria, medical history, concomitant treatments.	Baseline
Secondary	Treatments of Parkinson's disease	Description of PD treatments of included patients (Name, start date, end date, dose).	Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Secondary	Evolution of Oculomotor raw performance - 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. Parameter used for description, evolution and correlation studies.	Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Secondary	Evolution of Oculomotor raw performance - 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. Parameter used for description, evolution and correlation studies.	Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Secondary	Evolution of Oculomotor raw performance - 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. Parameter used for description, evolution and correlation studies.	Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Secondary	Evolution of Oculomotor raw performance - 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. Parameter used for description, evolution and correlation studies.	Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Secondary	Evolution of Oculomotor raw performance - 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. Parameter used for description, evolution and correlation studies.	Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Secondary	Evolution of Oculomotor raw performance - 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. Parameter used for description, evolution and correlation studies.	Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Secondary	Inhibition capacity	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. Parameter used for description, evolution and correlation studies.	Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Secondary	Internuclear ophthalmoplegia (INO) detection	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. Parameter used for description, evolution and correlation studies.	Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Secondary	Fixations impairments detection	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. Parameter used for description, evolution and correlation studies.	Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Secondary	Neurological evaluation - evolution of motor disorders	Motor disorders are applause sign, Pyramidal signs, conjugate oculomotricity disorders, cerebellar syndrome. They are categorised as present/absent following neurological clinic evaluation. These parameters are used for description, evolution and correlation analysis.	Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Secondary	Neurological evaluation - Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III	Score on the Part III subscale of the MDS-UPDRS, that assesses the motor signs of PD. Scores range from 0-33 with a lower score indicating less severe impairment. These scores are used for description, evolution and correlation studies.	Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Secondary	Neurological evaluation - Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV	Score on the Part IV subscale of the MDS-UPDRS, that assesses the motor complications of PD. Scores range from 0-6 with a lower score indicating less severe impairment. These scores are used for description, evolution and correlation studies.	Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Secondary	Neurological evaluation - Movement Disorder Society Non-Motor rating Scale (MDS-NMS)	This Non-Motor rating Scale measures frequency and severity of 13 non-motor domains, over 52 items, and covers a range of key non-motor symptoms both PD and treatment related. The MDS-NMS total score is the sum of the 13 non-motors domains subscales scores (these subscales' scores are the sum of the frequency multiplied by the intensity of each items composing each 13 non-motor domains). Higher score means a worse outcome. Score range 0-832. These scores are used for description, evolution and correlation studies.	Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Secondary	Neurological evaluation - Movement Disorder Society Non-Motor rating Scale (MDS-NMS) Non-Motor Fluctuations (NMF)	The MDS-NMS has a Non-Motor Fluctuations subscale (NMF) to assess changes in non-motor symptoms in relation to the timing of anti-parkinsonian medications across 8 domains. The MDS-NMS NMF Total score is the Subscore "Change" (range 0-32) multiplied by Subscore "Time" (range 1-4). The MDS-NMS NMF Total score range is 0-128. Higher score means a worse outcome.; This score is used for description, evolution and correlation studies. [Time Frame: Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable]	Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Secondary	Orthostatic hypotension	Blood pressure measures in order to determine presence or absence of Orthostatic hypotension. These parameters are used for description, evolution and correlation studies.	Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable
Secondary	MRI scan	Brain MRI data described according to their nature (lesion / atrophy / anomaly / Score Fasekas) are classified as normal or abnormal.	Baseline; Year 3; Year 7
Secondary	DAT scan	Cerebral DAT-Scan data are classified as presence/absence of Dopaminergic denervation.	Baseline; Year 3; Year 7
Secondary	PET/CT scan	Cerebral F-Dopa PET/CT-Scan data are classified as presence/absence of Dopaminergic denervation.	Baseline; Year 3; Year 7
Secondary	MIBG myocardial scintigraphy	MIBG myocardial scintigraphy are classified as normal/abnormal.	Baseline; Year 3; Year 7
Secondary	Mini Mental State (MMSE)	Mini Mental State (MMSE) is used to evaluate Global cognitive performance. MMSE is a 30-question general cognitive function assessment. The maximum score is 30. Performance of each participant is compared to their reference sample (depending on age, sex and level study). Scores are used for description, evolution and correlation studies.	Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
Secondary	Evolution of general cognitive behavior	The Mattis Dementia Rating Scale is used to to evaluate general cognitive behavior of subjects with suspected dementia. The scale is made up of 36 items divided into 5 complementary parts, each corresponding to a cognitive function: attention, initiation, construction, conceptualization, memory. The total score is /144 points. Score is used for description, evolution and comparison studies. Higher score means a better outcome.	Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
Secondary	Episodic memory performance	The GROBER et BUSCHKE Free and Cued recall (16 items) is used to evaluate Episodic memory. Performances of each participant are compared to their reference sample (depending on age, sex and level study). These parameters are used for description, evolution and correlation studies.	Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
Secondary	Executive performance - T.M.T	Trail Making Test (T.M.T) A&B is used to evaluate executive performance. The task requires a subject to connect a sequence of 25 consecutive targets on a sheet of paper, in the shortest time possible without lifting the pen from the paper. Time performances of each participant are compared to their reference sample. These parameters are used for description, evolution and correlation studies.	Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
Secondary	Executive performance - Stroop test	Stroop test (GREFFEX) is used to evaluate executive performance and more specifically inhibition. The time to complete each condition (in seconds) is recorded, as well as the number of uncorrected and corrected errors. Stroop task performances of each participant are compared to their reference sample. These parameters are used for description, evolution and correlation studies.	Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
Secondary	Executive performance - B.R.E.F.	The "Batterie rapide d'évaluation frontale" (B.R.E.F.), or Frontal Assessment Battery at Bedside (F.A.B.), is used to determine the presence or not of a cognitive and behavioral dysexecution syndrom. The maximum score is 18. Performances of each participant are compared to their reference sample. These parameters are used for description, evolution and correlation studies.	Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
Secondary	Verbal fluency	Verbal fluency test is a short test of verbal functioning. It consists of two tasks: category fluency and letter fluency. Participant is given 1 minute to produce as many unique words as possible within a semantic category (category fluency) or starting with a given letter (letter fluency). The participant's score in each task is the number of unique correct words. Performances of each participant are compared to their reference sample. These parameters are used for description, evolution and correlation studies.	Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
Secondary	Visuospatial function	Visual Object and Space Perception battery (VOSP) consists of eight tests each designed to assess a particular aspect of object or space perception, while minimizing the involvement of other cognitive skills. Performance of each participant is compared to their reference sample.; This parameter is used for description, evolution and comparison studies.	Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
Secondary	Visuospatial/constructional ability	Rey-complex copy figure test is used to evaluate visuospatial/constructional abilities. Performance of each participant is compared to their reference sample. These parameters are used for description, evolution and comparison studies.	Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
Secondary	Praxis assessment	Praxies idéomotrices (Mahieux) is a neuropsychological measure of imitation of meaningless gestures (score /8), symbolic gestures (score /5), pantomimes (score /10). Motor praxis are also measured (kinesthetic praxis, melokinetic praxis). These parameters are used for description, evolution and correlation analysis.	Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7
Secondary	Social cognition and Emotional assessment	A test battery made up of the Faux pas recognition test and a facial emotion recognition test (The Mini-sea) are used to evaluate Social cognition and Emotional assessment.; Evaluation criteria: Score to The Faux pas recognition test (/15), and scores to facial emotion recognition test (total score / 35 and sub-scores / 5). Performances of each participant are compared to their reference sample.; These parameters are used for description, evolution and correlation studies.	Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7