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Multidisciplinary Follow-up of Patients With Amyotrophic Lateral Sclerosis

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ClinicalTrials.gov Identifier: NCT03536962
Recruitment Status : Unknown
Verified April 2018 by Ruxandra Iancu Ferfoglia, University Hospital, Geneva.
Recruitment status was:  Active, not recruiting
First Posted : May 25, 2018
Last Update Posted : May 25, 2018
Information provided by (Responsible Party):
Ruxandra Iancu Ferfoglia, University Hospital, Geneva

Brief Summary:
Analyse a multidisciplinary follow-up of amyotrophic lateral sclerosis patients, monitored through a Cohort study at Geneva University Hospitals.

Condition or disease Intervention/treatment
Amyotrophic Lateral Sclerosis Other: no intervention

Detailed Description:

Since April 2010 a quarterly follow-up is available for patients with ALS at Geneva University Hospitals. It takes place in the outpatient unit of the Department of Neurology, and includes interventions by the multidisciplinary team of the " Center for Amyotrophic Lateral Sclerosis and related diseases ". This new tracking method can help improving quality of life of patients and their families by adapting medical care, proposing communication aids, facilitating access to specialized examinations and anticipating pulmonary, nutritional and neurologic complications. Moreover, it speeds up administrative procedures, improves the flow of information between medical teams inside and outside the hospital and it allows and encourages discussion about advanced directives.

Since June 2012, the multidisciplinary follow-up is monitored through a Cohort study that was approved by the ethical committee (NAC 11-062R). We collect clinical examination findings, anthropometric evaluation, blood analyses, pulmonary function tests, respiratory muscle strength, arterial blood gases, nocturnal oximetry, and evaluation by occupational therapists and by physiotherapists on a quarterly basis. Nerve conduction studies are done at the beginning of the follow-up to identify the degree and extent of loss of upper and lower motoneurons in ALS and to help guiding the diagnosis. MRI and analysis of cerebrospinal fluid are also acquired at the beginning of the follow-up in order to rule out other diagnoses which can mimic ALS. Definite, probable or possible ALS is defined according to the Revised El Escorial and Awaji criteria [16-17]. Patients are referred to a genetic counselor who helps making informed decisions regarding genetic issues. The data collected are inserted into the Secu-Trial database, which is managed by an assistant provided by the Clinical Research Center.

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cohort Study: Multidisciplinary Follow-up of Patients With Amyotrophic Lateral Sclerosis
Actual Study Start Date : June 1, 2012
Actual Primary Completion Date : September 1, 2016
Estimated Study Completion Date : October 1, 2018

Intervention Details:
  • Other: no intervention
    no intervention

Primary Outcome Measures :
  1. Longitudinal change of the revised Amyotrophic Lateral Sclerosis Functional rating scale in Amyotrophic Lateral Sclerosis patients [ Time Frame: 2012-2016 ]
    Clinical evolution of Amyotrophic Lateral Sclerosis patients will be measured by the revised Amyotrophic Lateral Sclerosis Functional rating scale. This scale includes 12 questions covering 4 distinct domains: fine motor function, gross motor function, respiratory function and bulbar symptoms. Lower scores indicate higher disability.This score will be assessed every three months

Secondary Outcome Measures :
  1. Correlation of walking speed measured by Timed Up and Go test and the Amyotrophic Lateral Sclerosis Functional rating scale (ALSFRS-R) [ Time Frame: 2012-2016 ]
    the Timed Up and Go test measures the time needed to rise from a chair walk 3 m, turn around and return to a seated position. The speed at which patients perform this test is measured in seconds and will be assessed at each trimestrial visit and will be correlated the (ALSFRS-R)

  2. Longitudinal evolution of pulmonary function in ALS patients [ Time Frame: 2012-2016 ]
    Vital capacity(in Liters) will be assessed at each trimestrial visit

  3. Evolution of body mass composition measured by the Body Mass Index in ALS patients [ Time Frame: 2012-2016 ]
    the Body Mass Index (kg/m2), will be assessed at each trimestrial visit

  4. Longitudinal evolution of inspiratory muscle strength in ALS patients [ Time Frame: 2012-2016 ]
    inspiratory muscle strength (in cmH2O) will be assessed at each trimestrial visit

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients living in the Geneva area suffering from Amyotrophic Lateral Sclerosis or related disorders

Inclusion Criteria:

Amyotrophic Lateral Sclerosis fulfilling the El Escorial criteria (definite, probable, possible), primary lateral sclerosis, progressive muscular atrophy, progressive bulbar palsy

Exclusion Criteria:

Patients with other neurological diagnoses than mentioned in the inclusion criteria

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): NCT03536962

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Geneva University Hospital
Geneva, Switzerland, 1205
Sponsors and Collaborators
Ruxandra Iancu Ferfoglia
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Study Chair: Jean-Paul Janssens, MD University Hospital, Geneva
Additional Information:
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Responsible Party: Ruxandra Iancu Ferfoglia, Chief resident, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03536962    
Other Study ID Numbers: NAC 11-062R
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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