Study of Eye Movements (EYE) as Early Markers of Brain Dysfunction (BRAIN) in Parkinson's Disease (PARK)

Parkinson Disease Clinical Trial

— eyebrainpark  

Official title:

Study of Eye Movements (EYE) as Early Markers of Brain Dysfunction (BRAIN) in Parkinson's Disease (PARK)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04212637
• Other study ID #: 38RC18.214
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2021
• Est. completion date: January 2022

Study information

• Verified date: November 2020
• Source: University Hospital, Grenoble
• Contact: Carole PEYRIN, PhD
• Phone: (0)4 7682-5879
• Email: carole.peyrin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Identify the neural bases of eye movements during visual tasks and their dysfunction at early stages of Parkinson disease (de novo).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: January 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria for all:

• Visual acuity normal or corrected to normal
• Affiliation to a social security scheme (copy of the vital card in support)
• Signed informed consent
• Medical examination according to the participation in the MRI examination
• MMSE score> 23/30

For Parkinson patient:

• Diagnosis of Parkinson's disease
• Presence of asymmetric bradykinesia and rest tremor and / or stiffness
• Hoehn & Yahr Stadium I-II / V

Exclusion Criteria for all:

• Unprotected Majors unable to express their consent
• Protected Major (Persons mentioned in Articles L1121-5,6 and 8 of the public health code)
• Significant hearing or motor impairment
• Past or present neuropsychiatric pathology (except benign epilepsy)
• Taking narcotics and / or drugs for neurocognitive purposes
• Existence of a severe condition in general (cardiac, respiratory, hematological, renal, hepatic, cancerous)
• Any other neurodegenerative pathology or treatment that may affect the oculomotor control

For Parkinson patient:

• Treatment for Parkinson's disease (except the inhibitors of monoaminoxidase B or MAO-B, such as selegiline and rasagiline).

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• MRI
Examine BOLD activity in relation to eye movements measures

Locations

Country	Name	City	State
France	CHU Grenoble-Alpes	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Laboratoire de Psychologie et NeuroCognition

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI images	Functional and anatomical brain volumes	1 hour
Secondary	Eye latency	latency (milliseconds) of ocular saccades	1 hour
Secondary	eye amplitude	amplitude (degree) of ocular saccades	1 hour