Effects of Gastrostomy on Amyotrophic Lateral Sclerosis

Results about effects of symptomatic treatment on QoL appears conflicting in ALS patients. Moreover no clear effects of gastrotomy have be shown on survival. Prospective study on effect of tube feeding, QoL and survival is performed in 17 teaching hospitals in France (observational study)

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clermont-Ferrand University Hospital

Clermont-Ferrand, 63003, France

About this study

Following data have been recorded each three months: QoL (MOS-SF 36 and ALSAQ), bodily mass index, testing and ALS-FRS scale, functional respiratory measures, impedance analysis, and the time for tube feeding procedure, the conditions of the acceptance and side-effects of gastrotomy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients > 18 years-old
ALS certain or probable
vital capacity (respiratory) > 70 %
under riluzole

Exclusion criteria

ALS in family
other conditions affected survival and QoL
cognitive impairment

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

Central Hospital, Nancy, France
Centre Hospitalier Universitaire de Nice
Neurological department of Lyon University Hospital
University Hospital, Angers
University Hospital, Bordeaux
University Hospital, Caen
University Hospital, Grenoble
University Hospital, Lille
University Hospital, Limoges
University Hospital, Marseille
University Hospital, Montpellier
University Hospital, Paris
University Hospital, Strasbourg
University Hospital, Toulouse
University Hospital, Tours

Registry information

Official study title

Effects of Gastrostomy on Quality of Life and Survival in Patients With Amyotrophic Lateral Sclerosis

Important dates

Study start: 2002
Study completion: 2005
First posted: Jun 16, 2006
Registry last updated: Nov 22, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed