Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04860791
Other study ID # 20-PP-03
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 10, 2021
Est. completion date May 31, 2023

Study information

Verified date February 2024
Source Centre Hospitalier Universitaire de Nice
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

MS is an autoimmune disease of the central nervous system that affects more than 120,000 people in France. The average age of onset of the disease is between 25 and 35 years. Given the wide range of ages of the patients, from 4 to 80 years, the ethical and socio-economic stakes are high in order to maintain their autonomy, sociability, family and intimate life, and their employment in the best possible conditions and for as long as possible. However, to date, there are no evaluation tools in French that allow us to understand the difficulties at work of MS patients. The Multiple Sclerosis Work Difficulties Questionnaire (MSWDQ-23) was developed specifically for MS patients and validated in English [1]. There is a short version of this questionnaire that facilitates its use in clinical practice [2]. It has been translated and validated in Spanish through a multicenter study, and is currently being validated in German, but does not currently exist in French [3]. The main objective of the WORKSEP project is to validate the French version of this questionnaire through a multicenter population-based cohort within the framework of the French-speaking Multiple Sclerosis Society (SFSEP). This validation study will involve the inclusion of 206 French-speaking MS patients, regardless of their professional status, all forms of MS combined, from the early stage (Clinically Isolated Syndrome) to the more advanced stages (primary and secondary progressive forms).


Recruitment information / eligibility

Status Completed
Enrollment 206
Est. completion date May 31, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Age between 18 and 65 years old. - Native French speaker. - A diagnosis of Clinically Isolated Syndrome or MS defined according to the 2017 McDonald criteria. - Be affiliated with the social security system. - Agree to participate in the study. Exclusion Criteria: Opposition to the use of the data

Study Design


Related Conditions & MeSH terms


Intervention

Other:
questionnaires
Patients will complete the MSWDQ-23 in French, as well as the DEX, questionnaire for the evaluation of executive dysfunction in daily life, to evaluate their cognitive complaints and the SF36 questionnaire to evaluate their quality of life

Locations

Country Name City State
France Besancon University Hospital Besançon
France Bordeaux university hospital Bordeaux
France Caen university hospital Caen
France Clermont Ferrand university hospital Clermont-Ferrand
France Gonesse hospital Gonesse
France Libourne hospital Libourne
France Lille University Hospital Lille
France Groupement des Hôpitaux de l'Institut Catholique de Lille Lomme
France Lyon University Hospital Lyon
France Marseille University Hospital Marseille
France Nancy Hospital Nancy
France Nimes university hospital Nîmes
France APHP Paris
France Rouen univestity hospital Rouen
France Saint Etienne University Hospital Saint-Étienne
France Strasnourg university hospital Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary MSWDQ-23 score total score out of 100 1 day
See also
  Status Clinical Trial Phase
Completed NCT05528666 - Risk Perception in Multiple Sclerosis
Completed NCT03608527 - Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis N/A
Recruiting NCT05532943 - Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis Phase 1/Phase 2
Completed NCT02486640 - Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
Completed NCT01324232 - Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis Phase 2
Completed NCT04546698 - 5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
Active, not recruiting NCT04380220 - Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
Completed NCT02835677 - Integrating Caregiver Support Into MS Care N/A
Completed NCT06110936 - Effects of Transcutaneous Spinal Direct Current Stimulation on Mobility in Cases With Multiple Sclerosis N/A
Completed NCT03686826 - Feasibility and Reliability of Multimodal Evoked Potentials
Recruiting NCT06021561 - Orofacial Pain in Multiple Sclerosis
Recruiting NCT05964829 - Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis N/A
Completed NCT03653585 - Cortical Lesions in Patients With Multiple Sclerosis
Recruiting NCT04798651 - Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis N/A
Active, not recruiting NCT05054140 - Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis Phase 2
Completed NCT05447143 - Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis N/A
Recruiting NCT06195644 - Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients Phase 1
Completed NCT04147052 - iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis N/A
Completed NCT03591809 - Combined Exercise Training in Patients With Multiple Sclerosis N/A
Completed NCT03594357 - Cognitive Functions in Patients With Multiple Sclerosis