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Effects of Gastrostomy on Amyotrophic Lateral Sclerosis

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ClinicalTrials.gov Identifier: NCT00337402
Recruitment Status : Completed
First Posted : June 16, 2006
Last Update Posted : November 22, 2006
Sponsor:
Collaborators:
University Hospital, Angers
University Hospital, Bordeaux
University Hospital, Caen
University Hospital, Grenoble
University Hospital, Lille
University Hospital, Limoges
Neurological department of Lyon University Hospital
University Hospital, Marseille
University Hospital, Montpellier
Central Hospital, Nancy, France
Centre Hospitalier Universitaire de Nice
University Hospital, Paris
University Hospital, Strasbourg
University Hospital, Toulouse
University Hospital, Tours
Information provided by:
University Hospital, Clermont-Ferrand

Brief Summary:
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)

Condition or disease
Amyotrophic Lateral Sclerosis

Detailed Description:
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

Study Type : Observational
Estimated Enrollment : 380 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Effects of Gastrostomy on Quality of Life and Survival in Patients With Amyotrophic Lateral Sclerosis
Study Start Date : January 2002
Estimated Study Completion Date : June 2005






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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00337402


Locations
France
Clermont-Ferrand University Hospital
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
University Hospital, Angers
University Hospital, Bordeaux
University Hospital, Caen
University Hospital, Grenoble
University Hospital, Lille
University Hospital, Limoges
Neurological department of Lyon University Hospital
University Hospital, Marseille
University Hospital, Montpellier
Central Hospital, Nancy, France
Centre Hospitalier Universitaire de Nice
University Hospital, Paris
University Hospital, Strasbourg
University Hospital, Toulouse
University Hospital, Tours
Investigators
Principal Investigator: Pierre Clavelou University Hospital, Clermont-Ferrand

ClinicalTrials.gov Identifier: NCT00337402     History of Changes
Other Study ID Numbers: CHU63-0001
First Posted: June 16, 2006    Key Record Dates
Last Update Posted: November 22, 2006
Last Verified: June 2006

Keywords provided by University Hospital, Clermont-Ferrand:
Gastrostomy
Quality of life

Additional relevant MeSH terms:
Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases