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Clinical Trial 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 (Observatoire Francais de la Sclérose en Plaques), 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.


Clinical Trial Description

Multiple sclerosis (MS) is a common autoimmune disease of the central nervous system. The repetition of relapses and their severity will lead in the long term to the accumulation of disability. The risk factors for relapses are still poorly understood, but it is suspected that air pollution and seasonal viral infections may increase the risk of relapse. The Sars-Cov-2 virus pandemic has abruptly disrupted the daily environment, to date three lock-down periods have been implemented to limit the spread of COVID 19, the first was from March 17 to May 11, 2020, the second was less strict from October 30 to December 15, 2020, and the third began April 3, 2021. The reduction in road traffic during the first containment was accompanied in Ile de France by a 30 to 50% decrease in fine particulate matter and nitrogen oxide air pollution compared to the previous year. The confinements and the generalized application of barrier measures have also been associated with a clear decrease in the circulation of seasonal viruses (Weekly Epidemiological Bulletin, February 17, 2021), in particular influenza and viral gastroenteritis viruses, compared to the previous year. To date, the impact of measures to prevent the spread of the Sars-CoV-2 epidemic on the risk of MS relapse has not been studied. However, these periods offer a unique opportunity to assess, in a quasi-experimental model, the impact of air pollution and viral infections on the risk of MS relapse, in a context where these factors have shown large variations compared to the usual seasonal values observed. The pandemic has also had a profound impact on the health care system, with the corollary that patients with chronic pathologies have had difficulty accessing care, as hospital structures have had to deal with an unprecedented crisis, resulting in the de-scheduling of non-urgent procedures and great difficulty in accessing in-person consultations. Numerous uncertainties concerning the risk of severe COVID-19 in patients treated with immunomodulators or immunosuppressants have led to the suspension or delay of the initiation of immuno-active treatments to prevent the aggravation of the disease. To date, no study has evaluated the impact of changes in the management of MS patients during this particular period and to assess the impact on the progression of neurological disability. The primary objective of the study will be to determine the impact of environmental risk factors (air pollution, exposure to seasonal viruses) and health care access on the risk of clinical MS relapse, in the context of the lockdown period. The secondary objective will be to assess the impact of environmental risk factors (air pollution, exposure to seasonal viruses) and health care access on the risk of clinical MS relapse, in the context of the lockdown perio on the risk of relapse and accumulation of MS disability. This study will include patients followed in the neurology department of the Pitié Salpêtrière Hospital in Paris for relapsing-remitting MS. Inclusion visit: - Conducted during the patient's usual follow-up (consultation / day hospital). - Information and collection of non-opposition by the investigating neurologist - Clinical examination to evaluate the disability (EDSS scale), as part of the care (systematic for all MS consultations) - A paper questionnaire is given to the patient during the consultation. The patient will be contacted by telephone within 15 days after the consultation by a health care staff to collect the answers to the questionnaire. Different sources of data will be used together: 1. Clinical data from the OFSEP registry (French Multiple Sclerosis Observatory). OFSEP is a national registry in which neurological clinical data of MS patients are prospectively collected. (i) Date of first symptoms of the disease (ii) Date of diagnosis (iii) Date of disease relapses, date of first symptoms of the relapse (iv) Neurological disability score at each neurological assessment as assessed by the EDSS score (v) Nature, date of initiation and discontinuation of treatment and reasons for discontinuation (vi) Comorbidities, infectious and neoplastic complications (vii) Education level 2. Data from the telephone questionnaire: (i) Zip code of patient's iterative residences since 2018, as well as zip code of residence at the time of the two confinements (ii) Occupational status (iii) Occurrence of COVID infection/date needed for hospitalization (iv) 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 change(s) was: decided by the patient, recommended by the treating physician, recommended by the neurologist, other (specify) (v) During the COVID-19 outbreak, did the patient stop his or her rehabilitation care (physical therapy, speech therapy)? If yes, date of cessation, duration, reason for cessation (planned, decided by the patient, recommended by the rehabilitation specialist, recommended by the attending physician, recommended by the neurologist) 3. Pollution data from approved air quality monitoring associations (AASQA): for the Ile de France region, this is AIR PARIF, which collects the daily average exposure to fine particles (PM10, PM2.5), ozone (O3), and nitrogen oxides (NO2) at 37 stations in the different departments of Ile de France. The data from the station closest to each patient's home will be analyzed. 4. Data on the circulation of influenza and gastroenteritis, produced by Santé Publique France (Sentinelles network, OSCOUR network, National Reference Center for Respiratory Infections Viruses). Methods: Single-center retrospective observational cohort study Primary endpoint: The primary endpoint will be the occurrence of an MS relapse in relation to exposure to air pollution, seasonal viral infections, and limitation of health care access during periods of lockdown. Secondary endpoints: The secondary endpoint will be the occurrence of an MS disability accumulation in relation to exposure to air pollution, seasonal viral infections, and limitation of health care access during periods of lockdown. Inclusion period: from December 2021 to September 2022 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05033782
Study type Observational
Source Assistance Publique - Hôpitaux de Paris
Contact Edouard Januel, MD
Phone 142161975
Email [email protected]
Status Not yet recruiting
Phase
Start date December 1, 2021
Completion date September 15, 2022

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