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
- Diseases
- Multiple sclerosis
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Neurology Department, Hopital de la Pitié Salpêtrière Coordinator of this site? Confirm its status | Paris | France | Unknown status |
Related publications
- Air pollution and the risk of multiple sclerosis relapses in the Paris region, the CONFISEP study.J Neurol Neurosurg Psychiatry · 2026 · PMID 42816171
This page is information, not medical advice. Discuss any trial with your doctor.