Optical Coherence Tomography in Neurological Practice: Utility and Applicability Across Neurological Diseases (OCt.IN.N)

NCT07720765 | Recruiting

• 1 other identifier: OCtINN
• Study Type: observational
• Target: 1,050
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Parkinson Disease; Migraine; Headache Disorders; Multiple Sclerosis

Keywords

Optical Coherence Tomography; OCT; Retinal nerve fiber layer; RNFL; Ganglion cell layer; GCL; Multiple Sclerosis; Alzheimer's disease; Parkinson's disease; Migraine; Neurodegeneration; Neuro-retina; Biomarker

Outcome Measures

Primary Outcomes (9)

• Annual rate of peripapillary RNFL thinning in patients with Multiple Sclerosis vs healthy controls

  Annualized thinning rate (micrometers per year) of the peripapillary retinal nerve fiber layer (RNFL) measured by OCT in patients with Multiple Sclerosis compared to age-matched healthy controls.

  Baseline, 6, 12, 18, and 24 months

• Annual rate of peripapillary RNFL thinning in patients with Alzheimer's Disease vs healthy controls

  Annualized thinning rate (micrometers per year) of the peripapillary retinal nerve fiber layer (RNFL) measured by OCT in patients with Alzheimer's Disease compared to age-matched healthy controls.

  Baseline, 6, 12, 18, and 24 months

• Annual rate of peripapillary RNFL thinning in patients with Parkinson's Disease vs healthy controls

  Annualized thinning rate (micrometers per year) of the peripapillary retinal nerve fiber layer (RNFL) measured by OCT in patients with Parkinson's Disease compared to age-matched healthy controls.

  Baseline, 6, 12, 18, and 24 months

• Annual rate of macular GCL thinning in patients with Multiple Sclerosis disease vs healthy controls

  Annualized thinning rate (micrometers per year) of the macular ganglion cell layer (GCL) measured by OCT in patients with Multiple Sclerosis compared to age-matched healthy controls

  Baseline, 6, 12, 18, and 24 months

• Annual rate of macular GCL thinning in patients with Alzheimer's Disease vs healthy controls

  Annualized thinning rate (micrometers per year) of the macular ganglion cell layer (GCL) measured by OCT in patients with Alzheimer's Disease compared to age-matched healthy controls

  Baseline, 6, 12, 18, and 24 months

• Annual rate of macular GCL thinning in patients with Parkinson's Disease vs healthy controls

  Annualized thinning rate (micrometers per year) of the macular ganglion cell layer (GCL) measured by OCT in patients with Parkinson's Disease compared to age-matched healthy controls

  Baseline, 6, 12, 18, and 24 months

• Annual rate of macular IPL thinning in patients with Multiple Sclerosis vs healthy controls

  Annualized thinning rate (micrometers per year) of the macular inner plexiform layer (IPL) measured by OCT in patients with Multiple Sclerosis compared to age-matched healthy controls

  Baseline, 6, 12, 18, and 24 months

• Annual rate of macular IPL thinning in patients with Alzheimer's Disease vs healthy controls

  Annualized thinning rate (micrometers per year) of the macular inner plexiform layer (IPL) measured by OCT in patients with Alzheimer's Disease compared to age-matched healthy controls

  Baseline, 6, 12, 18, and 24 months

• Annual rate of macular IPL thinning in patients with Parkinson's Disease vs healthy controls

  Annualized thinning rate (micrometers per year) of the macular inner plexiform layer (IPL) measured by OCT in patients with Parkinson's Disease compared to age-matched healthy controls

  Baseline, 6, 12, 18, and 24 months

Secondary Outcomes (29)

• Correlation between RNFL thinning rate and EDSS worsening in Multiple Sclerosis

  Baseline, 6, 12, 18, and 24 months

• Correlation between GCL thinning rate and EDSS worsening in Multiple Sclerosis

  Baseline, 6, 12, 18, and 24 months

• Correlation between IPL thinning rate and EDSS worsening in Multiple Sclerosis

  Baseline, 6, 12, 18, and 24 months

• Correlation between RNFL thinning rate and UPDRS worsening in Parkinson's disease

  Baseline, 6, 12, 18, and 24 months

• Correlation between GCL thinning rate and UPDRS worsening in Parkinson's disease

  Baseline, 6, 12, 18, and 24 months

Study Arms (5)

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.

Device: Optical Coherence Tomography (OCT) - Heidelberg SPECTRALIS HRA+OCT

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.

Device: Optical Coherence Tomography (OCT) - Heidelberg SPECTRALIS HRA+OCT

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.

Device: Optical Coherence Tomography (OCT) - Heidelberg SPECTRALIS HRA+OCT

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.

Device: Optical Coherence Tomography (OCT) - Heidelberg SPECTRALIS HRA+OCT

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.

Device: Optical Coherence Tomography (OCT) - Heidelberg SPECTRALIS HRA+OCT

Interventions

Optical Coherence Tomography (OCT) - Heidelberg SPECTRALIS HRA+OCT DEVICE

Spectral-domain Optical Coherence Tomography (OCT) performed using the Heidelberg SPECTRALIS HRA+OCT device (Class IIa CE-marked medical device). The procedure is non-invasive: the patient sits in front of the device and is asked to fix a target (light or cross) through a lens. No drugs or contrast agents are administered. OCT automatically acquires images of the macular region (where GCL and IPL are most represented) and the optic nerve head region (where RNFL is most represented), providing automated measurements of the thickness of individual retinal layers. OCT is performed at baseline and at follow-up visits at 6, 12, 18, and/or 24 months. Ophthalmological evaluation may be performed at the investigators' discretion if OCT images, clinical symptoms, or medical history suggest concurrent ocular pathology. Patients with a known diagnosis of epilepsy or history of epileptic seizures will not undergo specific imaging modes using clearly visible light sources (MultiColor, FA, BAF).

Alzheimer's disease patients; Healthy Controls; Migraine and headache patients; Multiple Sclerosis patients; Parkinson's disease patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with a diagnosis of a Central Nervous System neurological disease (Multiple Sclerosis; Alzheimer's disease; Parkinson's disease; migraine/headache) recruited from the neurology outpatient clinics and inpatient wards of IRCCS San Raffaele Hospital, Milan, Italy. Healthy controls recruited primarily from medical students, colleagues, and relatives of patients.

You may qualify if:

• 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.

You may not qualify if:

• Refusal to participate or withdrawal of informed consent.
• Known or confirmed ocular pathology identified during examination (ophthalmological evaluation may be requested at the investigators' discretion).
• Inability to understand instructions given by investigators.
• Presence of any condition that, in the investigators' opinion, renders the subject unsuitable for the study.
• For specific imaging modes using clearly visible light sources (MultiColor, FA, BAF): diagnosis of epilepsy or history of previous epileptic seizures.
• Refusal to participate or withdrawal of informed consent.
• Known or confirmed ocular pathology identified during examination.
• Inability to understand instructions given by investigators.
• Presence of any condition that, in the investigators' opinion, renders the subject unsuitable for the study.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele - Neurology and Neurophysiology Unit

Milan, Milano, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Alzheimer Disease; Parkinson Disease; Migraine Disorders; Headache Disorders; Nerve Degeneration

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Headache Disorders, Primary; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Massimo Filippi, Prof, MD

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federica Agosta, MD

CONTACT

0226433051; agosta.federica@hsr.it

Roberto Santangelo, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof, MD

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 22, 2026
• Study Start: October 9, 2023
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2031
• Last Updated: July 22, 2026

Record last verified: 2026-07

Locations

IT (1)