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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
Sponsor:
Information provided by (Responsible Party):
Ruxandra Iancu Ferfoglia, University Hospital, Geneva

Tracking Information
First Submitted Date January 14, 2018
First Posted Date May 25, 2018
Last Update Posted Date May 25, 2018
Actual Study Start Date June 1, 2012
Actual Primary Completion Date September 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 23, 2018)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 23, 2018)
  • 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)
  • Longitudinal evolution of pulmonary function in ALS patients [ Time Frame: 2012-2016 ]
    Vital capacity(in Liters) will be assessed at each trimestrial visit
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Multidisciplinary Follow-up of Patients With Amyotrophic Lateral Sclerosis
Official Title Cohort Study: Multidisciplinary Follow-up of Patients With Amyotrophic Lateral Sclerosis
Brief Summary Analyse a multidisciplinary follow-up of amyotrophic lateral sclerosis patients, monitored through a Cohort study at Geneva University Hospitals.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients living in the Geneva area suffering from Amyotrophic Lateral Sclerosis or related disorders
Condition Amyotrophic Lateral Sclerosis
Intervention Other: no intervention
no intervention
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: May 23, 2018)
60
Original Actual Enrollment Same as current
Estimated Study Completion Date October 1, 2018
Actual Primary Completion Date September 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03536962
Other Study ID Numbers NAC 11-062R
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Ruxandra Iancu Ferfoglia, University Hospital, Geneva
Study Sponsor Ruxandra Iancu Ferfoglia
Collaborators Not Provided
Investigators
Study Chair: Jean-Paul Janssens, MD University Hospital, Geneva
PRS Account University Hospital, Geneva
Verification Date April 2018