NCT07720765 Optical Coherence Tomography in Neurological Practice: Utility and Applicability Across Neurological Diseases (OCt.IN.N)
| NCT ID | NCT07720765 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele |
| Condition | Multiple Sclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,050 participants |
| Start Date | 2023-10-09 |
| Primary Completion | 2030-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,050 participants in total. It began in 2023-10-09 with a primary completion date of 2030-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria for neurological patients: 1. 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. 2. Age greater than 18 years. 3. Signed informed consent to study participation. 4. Willingness and ability to undergo all study visits and procedures. Inclusion Criteria for healthy controls: 1. Absence of neurological disease. 2. Age greater than 18 years. 3. Signed informed consent to study participation. 4. Willingness and ability to undergo all study visits and procedures. Exclusion Criteria for neurological patients: 1. Refusal to participate or withdrawal of informed consent. 2. Known or confirmed ocular pathology identified during examination (ophthalmological evaluation may be requested at the investigators' discretion). 3. Inability to understand instructions given by investigators. 4. Presence of any condition that, in the investigators' opinion, renders the subject unsuitable for the study. 5. For specific imaging modes using clearly visible light sources (MultiColor, FA, BAF): diagnosis of epilepsy or history of previous epileptic seizures. Exclusion Criteria for healthy controls: 1. Refusal to participate or withdrawal of informed consent. 2. Known or confirmed ocular pathology identified during examination. 3. Inability to understand instructions given by investigators. 4. Presence of any condition that, in the investigators' opinion, renders the subject unsuitable for the study.
Contact & Investigator
Massimo Filippi, Prof, MD
PRINCIPAL INVESTIGATOR
IRCCS San Raffaele
Frequently Asked Questions
Who can join the NCT07720765 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07720765 currently recruiting?
Yes, NCT07720765 is actively recruiting participants. Contact the research team at agosta.federica@hsr.it for enrollment information.
Where is the NCT07720765 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07720765 clinical trial?
NCT07720765 is sponsored by IRCCS San Raffaele. The principal investigator is Massimo Filippi, Prof, MD at IRCCS San Raffaele. The trial plans to enroll 1,050 participants.
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