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NCT05033782Completed

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

Impact of the Modifications of Environmental Exposures and Health Care Access During COVID-19 Lockdown on the Risk of Multiple Sclerosis Clinical Relapse or Clinical Worsening

Source: ClinicalTrials.gov · Last updated 13 Apr 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
1209 (actual)
First submitted
2 Sept 2021
Start date
Feb 2022
Primary completion date
Feb 2025
Lead sponsor
Assistance Publique - Hôpitaux de Paris
NCT number
NCT05033782

What you commit to

  • Study type: Observational
  • Participants enrolled: 1209
  • From Feb 2022 to the primary completion date, Feb 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Secondary progressive or primary progressive MS

Who the study is looking for

  • MS defined by the Mac-Donald 2017 criteria
  • Age greater than or equal to 18 years
  • Relapsing-remitting form
  • Patient residing in Ile de France
  • Patient included in the OFSEP registry (French Multiple Sclerosis Observatory) with at least one visit before 2020 and at least one after January 2021

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Neurology Department, Hopital de la Pitié Salpêtrière
Coordinator of this site? Confirm its status
ParisFranceUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.