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Impact of the Modifications of Environmental Exposures and Health Care Access During COVID-19 Lockdown on Multiple Sclerosis

NCT05033782 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1209

Last updated 2025-04-13

No results posted yet for this study

Summary

Multiple Sclerosis (MS) is a demyelinating auto immune disease of the central nervous system, affecting 2500000 people worldwide. Risk factors for MS severity are not yet well-known , but previous studies highlighted that relapse rate increased during influenzae epidemics, and air pollution could be a risk factor for MS relapses. MS is a neurological chronic disease that requires constant medical treatment and regular rehabilitation care. COVID-19 pandemic and restrictive measures taken to limit contaminations have drastically decreased air pollution and seasonal viral infections exposure, but sanitary crisis also limited care access for MS patients (medical treatment, rehabilitation). Therefore, this particular period offers a unique opportunity to evaluate the impact of air pollution, viral infections, and health care access on the severity of MS.

The main objective is to evaluate the impact of air pollution and seasonal viral infections on the risk of MS relapse, using the year 2020 as a quasi-experimental model. The secondary objective will be to evaluate the impact of health care access limitations on the risk of neurological disability accumulation.

This study will include 1500 MS patients, living in Ile de France, followed in the neurological department of "Pitié-Salpêtrière" Hospital. This is a retrospective observational study nested in OFSEP registry (French Multiple Sclerosis Observatory), which is a prospective cohort of MS patients in France. Air pollution data will come from AIRPARIF, and viral infections data will come from "Santé Publique France".

A better knowledge of the impact of air pollution, viral infections, and health care access on the course of MS will enable to better guide information to patients and public health care decisions.

Conditions

Interventions

OTHER

questionnaire

Each included patient will be given a paper questionnaire, with the following questions: * Zip code of patient's iterative residences since 2018, as well as the zip code of residence at the time of the 2 confinements * Occupational status * Occurrence of COVID infection/date needed for hospitalization * During the COVID-19 outbreak, did the patient: avoid seeing a doctor, avoid going to health care facilities, stop background treatment for MS. If yes to any of the questions, the reason, date and duration of the cessation will be asked. Other sources of data will be used together: Clinical data from the OFSEP registry Pollution data from approved air quality monitoring associations Data on the circulation of influenza and gastroenteritis, produced by Santé Publique France

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Edouard Januel, MD · Assistance Publique Hopitaux Paris

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-08
Primary Completion
2025-02-08
Completion
2025-02-08

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05033782 on ClinicalTrials.gov