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Effects of Gastrostomy on Amyotrophic Lateral Sclerosis

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00337402
First received: June 15, 2006
Last updated: November 20, 2006
Last verified: June 2006
History of Changes
  Purpose

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
Amyotrophic Lateral Sclerosis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Clermont-Ferrand:

Estimated Enrollment: 380
Study Start Date: January 2002
Estimated Study Completion Date: June 2005
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00337402     History of Changes
Other Study ID Numbers: CHU63-0001
Study First Received: June 15, 2006
Last Updated: November 20, 2006
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 22, 2013