Evaluation of Relapse Presence in Multiple Sclerosis

NCT05218317 | Completed

• 1 other identifier: 09.2021.240
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: This study aims to investigate the demonstrability of increased inflammation and neurodegeneration in multiple sclerosis (MS) patients in relapse period compared to MS patients in remission by cross-sectional analysis of in-vivo corneal confocal microscopy (IVCM), and to evaluate the alternations with a second IVCM administered at least 6 months after the relapse period. Methods: This prospective, non-randomized-controlled, cross-sectional study included 58 MS patients which were grouped regarding the presence of relapse (MS-Relapse group \[n=27\] and MS-Control group \[n=31\]), and age-sex matched 30 healthy controls (HC). The corneal nerve fiber density (CNFD), the corneal nerve branch density (CNBD), the corneal nerve fiber length (CNFL), and dendritic cell (DC) density were evaluated in all MS patients and HCs by IVCM. If the patients in the MS-relapse group did not have an attack within 6 months, the same parameters were evaluated with the second IVCM. The patients with a history of optic neuritis or trigeminal symptoms were excluded.

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis Relapse

Keywords

multiple sclerosis, in-vivo corneal confocal microscopy, relapse, inflammation, neurodegeneration, neuroregeneration

Outcome Measures

Primary Outcomes (6)

• Corneal nerve fiber density (CNFD)

  Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNFD.

  Baseline

• Corneal nerve fiber density (CNFD)

  Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNFD.

  6 Month

• Corneal nerve branch density (CNBD)

  Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNBD.

  Baseline

• Corneal nerve branch density (CNBD)

  Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNBD.

  6 Month

• Corneal nerve fiber length (CNFL)

  Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNFL.

  Baseline

• Corneal nerve fiber length (CNFL)

  Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNFL.

  6 Months

Secondary Outcomes (2)

• Dendritic Cells

  Baseline

• Dendritic Cells

  6 Months

Study Arms (3)

MS-Relapse

Twenty-seven patients (MS-Relapse) for whom the administration of intravenous corticosteroids was decided due to the diagnosis of new relapse. The diagnosis of RRMS and the new relapse was confirmed and decided by a senior neurologist (K.A) of Marmara University Department of Neurology, according to the revised McDonald criteria, based on clinical and radiological findings These subjects underwent Corneal Confocal Microscopy (IVCM).

Diagnostic Test: in-vivo Corneal Confocal Microscopy

MS-Control

Thirty-one patients (MS-Control) who were followed up with the diagnosis of RRMS The diagnosis of RRMS and the new relapse was confirmed and decided by a senior neurologist (K.A) of Marmara University Department of Neurology, according to the revised McDonald criteria, based on clinical and radiological findings. These subjects underwent Corneal Confocal Microscopy (IVCM).

Diagnostic Test: in-vivo Corneal Confocal Microscopy

Healthy Controls

Thirty healthy age and gender similar population These subjects underwent Corneal Confocal Microscopy (IVCM).

Diagnostic Test: in-vivo Corneal Confocal Microscopy

Interventions

in-vivo Corneal Confocal Microscopy DIAGNOSTIC_TEST

All study subjects underwent IVCM (Rostock Cornea Module, Heidelberg Retinal Tomograph III; Heidelberg Engineering, Germany). Before the examination, two drops of topical anesthetic with proparacaine hydrochloride (Alcaine 0.5%, Alcon-Couvreur, Belgium) were applied to both eyes. A carbomer-based gel (Viscotears 0.2%; Dr. Gerhard Mann, Chem.- Pharm. Fabrik, Germany) was used as the coupling agent between the cornea and the applanating cap of IVCM. For correctly positioning the central cornea, all subjects were asked to fixate a determined fixation point and controlled with the device camera. All scans were performed in approximately 5 minutes for each eye by a single experienced ophthalmologist, masked from the subject's disease status.

Healthy Controls; MS-Control; MS-Relapse

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Fifty-eight patients with RRMS and 30 HCs were included in the study. The RRMS patients were divided into two subgroups: 1) Thirty-one patients (MS-Control) who were followed up with the diagnosis of RRMS, 2) Twenty-seven patients (MS-Relapse) for whom the administration of intravenous corticosteroids was decided due to the diagnosis of new relapse.

You may qualify if:

• Patients for whom the administration of intravenous corticosteroids was decided due to the diagnosis of new relapse
• Patients who were followed up with the diagnosis of RRMS
• Healthy controls

You may not qualify if:

• Being younger than 18 years old
• Having any other neurological or metabolic diseases
• Ophthalmological diseases
• A history of optic neuritis and trigeminal symptoms
• Ocular trauma or surgery
• Contact lens use
• The patients who had a relapse attack 6 months prior to the study

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, 34899, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis; Recurrence; Inflammation; Nerve Degeneration

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 1, 2022
• Study Start: January 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: January 1, 2022
• Last Updated: February 1, 2022

Record last verified: 2022-01

Locations

TU (1)