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A National, Monocentric, Prospective Cohort Study to Evaluate the Utility and Applicability of Optical Coherence Tomography in Neurological Clinical Practice

Status: Recruiting

Location: See location...

Intervention Type: Device

Study Type: Observational

SUMMARY

OCt.IN.N is a national, monocentric, prospective, observational cohort study evaluating the utility and applicability of Optical Coherence Tomography (OCT) in the diagnostic workup and longitudinal monitoring of neurological diseases. 840 patients with Central Nervous System neurological diseases (Multiple Sclerosis, Alzheimer's disease, Parkinson's disease, migraine/headache) and 210 age-matched healthy controls will undergo OCT examination at baseline and at 6, 12, 18, and 24 months of follow-up at IRCCS San Raffaele Hospital, Milan, Italy. OCT is a non-invasive, rapid, and reproducible technique that automatically measures the thickness of individual retinal layers. Retinal layer thicknesses and their longitudinal changes will be correlated with established clinical scales, neuroimaging, and biological markers used in routine neurological practice.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: t

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• Diagnosis of a Central Nervous System neurological disease (inflammatory diseases such as Multiple Sclerosis; neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease; migraine/headache) according to currently accepted diagnostic criteria for each condition.

• Age greater than 18 years.

• Signed informed consent to study participation.

• Willingness and ability to undergo all study visits and procedures.

• Absence of neurological disease.

• Age greater than 18 years.

• Signed informed consent to study participation.

• Willingness and ability to undergo all study visits and procedures.

Locations

Other Locations

Italy

IRCCS Ospedale San Raffaele - Neurology and Neurophysiology Unit

RECRUITING

Milan

Contact Information

Primary

Federica Agosta, MD

agosta.federica@hsr.it

0226433051

Backup

Roberto Santangelo, MD

Time Frame

Start Date: 2023-10-09

Estimated Completion Date: 2031-04-01

Participants

Target number of participants: 1050

Treatments

Multiple Sclerosis patients

210 patients with a diagnosis of Multiple Sclerosis according to current diagnostic criteria, stratified into three age subgroups (20-40, 40-60, and over 60 years, 70 per subgroup). Undergo OCT at baseline and follow-up visits at 6, 12, 18, and/or 24 months, alongside standard clinical assessments including EDSS.

Alzheimer's disease patients

210 patients with a diagnosis of Alzheimer's disease according to current diagnostic criteria, stratified into three age subgroups (70 per subgroup). Undergo OCT at baseline and follow-up visits alongside standard neuropsychological assessments, brain MRI, PET, and CSF biomarkers as part of routine clinical care.

Parkinson's disease patients

210 patients with a diagnosis of Parkinson's disease according to current diagnostic criteria, stratified into three age subgroups (70 per subgroup). Undergo OCT at baseline and follow-up visits alongside standard clinical assessments including UPDRS.

Migraine and headache patients

210 patients with a diagnosis of migraine or headache according to current diagnostic criteria, stratified into three age subgroups (70 per subgroup). Undergo OCT at baseline and follow-up visits alongside standard clinical assessments.

Healthy Controls

210 healthy subjects without neurological disease, age-matched to patients, stratified into three age subgroups (20-40, 40-60, and over 60 years, 70 per subgroup). Recruited primarily from medical students, colleagues, and relatives of patients. Undergo OCT at baseline and follow-up visits.

Related Therapeutic Areas

Movement Disorders

Parkinson's Disease

Migraine

Multiple Sclerosis (MS)

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