NCT04731246|Recruiting
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Sponsor study identifier
interventional
30
1 country
1
Study Start
July 7, 2021
Actual (reported)Primary Completion
January 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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):
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 20, 2021
Actual (reported)January 29, 2021
Actual (reported)July 7, 2021
Actual (reported)January 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital
Monaco, 98000, Monaco
Philippe BARRES, MD
Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital, Monaco.
Sandrine LOUCHART DE LA CHAPELLE, MD-PHD
Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital, Monaco
Alain PESCE, PUPH
AREBISN (Association de Recherche Bibliographique pour les Neurosciences), Nice (France)
Caroline GIORDANA, MD
Centre Expert Parkinson, Unités des Pathologies du Mouvement, Hôpital Pasteur 2, Nice (France)
First Submitted
January 20, 2021
First Posted
January 29, 2021
Study Start
July 7, 2021
Actual (reported)Effects of Complementary Therapies in People With Mild to Moderate Parkinson's Disease
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
Contact the study team to confirm eligibility.
Benoit PAULMIER, MD
Médecine Nucléaire, Princess Grace Hospital, Monaco.
Primary Completion
January 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 13, 2026
Record last verified: 2026-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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