Informations générales (source: ClinicalTrials.gov)
Study of Predictive Factors of Progression of Motor Neurone Disease Prognosis and Endophenotype Biomarkers French Database Set up (PULSE)
Observational [Patient Registry]
University Hospital, Lille (Voir sur ClinicalTrials)
janvier 2015
janvier 2026
29 juin 2024
Amyotrophic lateral sclerosis (ALS) is a complex polymorph and devastating
neurodegenerative disease. Although the pathophysiological mechanisms underlying the
development of ALS remain to be fully elucidated, there have been significant advances in
the understanding of ALS pathogenesis, with evidence emerging of a complex interaction
between genetic factors and dysfunction of vital molecular pathways. However, the
numerous randomized clinical trials (RCT) for ALS have failed to generate improved drug
treatments. Biomarkers able to bring prognostic value and to distinguish the different
endophenotypes of this polymorphic disease could help to better select clusters of
patients in order to improve the RCT outcomes. However, little progress has been made in
the development of viable diagnostic, prognostic and monitoring markers. This could be
explained by common shortcomings, such as relatively small sample sizes, statistically
underpowered study designs, lack of disease controls and poorly characterized patient
cohorts. It is yet crucial that the investigators further develop and validate ALS
biomarkers and incorporate these biomarkers into the drug development pipeline for ALS.
The aim of the present study is therefore to determine the clinical, biological, imaging,
and electrophysiological biomarkers of prognosis of survival without events (i.e. severe
comorbidity, 24 hours of non invasive ventilation, tracheotomy). This is a prospective
observational multicentric French study of a cohort of 1000 ALS patients.
This large multimodal database will be open for international fruitful scientific
collaborations.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre Hospitalier - Saint Brieuc - France | Contact (sur clinicalTrials) | ||||
| CHRU, Hôpital Salengro - Lille - France | David Devos, MD, PhD | Contact (sur clinicalTrials) | |||
| CHU Bretonneau - Tours - France | Contact (sur clinicalTrials) | ||||
| CHU Cote de Nacre - Caen - France | Contact (sur clinicalTrials) | ||||
| CHU Pontchaillou - Angers - France | Contact (sur clinicalTrials) | ||||
| Hôpital de l'Archet 1, CHU - Nice - France | Contact (sur clinicalTrials) | ||||
| Hôpital Dupuytren - Limoges - France | Contact (sur clinicalTrials) | ||||
| Hôpital Gui de Chauliac - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Hôpital Neurologique Pierre Wertheimer - Lyon - France | Contact (sur clinicalTrials) | ||||
| Hôpital Nord - Saint Etienne - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HM,Hôpital de la Timone - Marseille - France | Contact (sur clinicalTrials) | ||||
| CHU Gabriel Montpied - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| Hôpital La Pitié (AP-HP) - Paris - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria for ALS patients:
- Patients with suspicion of Amyotrophic lateral sclerosis
- Since the first signs (cramps fasciculation) or first deficit at the diagnosis work
up
- Patient older than 18 years
- Patient able to provide informed consent
Inclusion Criteria for healthy controls:
- Subjects older than 18 years (matched population for age and sex with ALS)
- Neurological testing and examination showing no neurological disorders.
- Not having severe disease or life- functional prognosis
Inclusion Criteria for neurological controls:
- Patients having a typical neurodegenerative diseases other than ALS (Parkinson's
disease, Alzheimer's disease)
- Not having severe disease or life- functional prognosis
- Patient older than 18 years (matched population for age and sex with ALS)
- Patient able to provide informed consent
Exclusion Criteria:
- Subjects younger than 18 years
- Patient unable to provide informed consent
- Having severe disease or life- functional prognosis
- Contraindications MRI
- Patients with suspicion of Amyotrophic lateral sclerosis
- Since the first signs (cramps fasciculation) or first deficit at the diagnosis work
up
- Patient older than 18 years
- Patient able to provide informed consent
Inclusion Criteria for healthy controls:
- Subjects older than 18 years (matched population for age and sex with ALS)
- Neurological testing and examination showing no neurological disorders.
- Not having severe disease or life- functional prognosis
Inclusion Criteria for neurological controls:
- Patients having a typical neurodegenerative diseases other than ALS (Parkinson's
disease, Alzheimer's disease)
- Not having severe disease or life- functional prognosis
- Patient older than 18 years (matched population for age and sex with ALS)
- Patient able to provide informed consent
Exclusion Criteria:
- Subjects younger than 18 years
- Patient unable to provide informed consent
- Having severe disease or life- functional prognosis
- Contraindications MRI