- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03536962
Multidisciplinary Follow-up of Patients With Amyotrophic Lateral Sclerosis
Cohort Study: Multidisciplinary Follow-up of Patients With Amyotrophic Lateral Sclerosis
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Geneva, Switzerland, 1205
- Geneva University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Longitudinal change of the revised Amyotrophic Lateral Sclerosis Functional rating scale in Amyotrophic Lateral Sclerosis patients
Time Frame: 2012-2016
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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
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2012-2016
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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2012-2016
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Longitudinal evolution of pulmonary function in ALS patients
Time Frame: 2012-2016
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Vital capacity(in Liters) will be assessed at each trimestrial visit
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2012-2016
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Evolution of body mass composition measured by the Body Mass Index in ALS patients
Time Frame: 2012-2016
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the Body Mass Index (kg/m2), will be assessed at each trimestrial visit
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2012-2016
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Longitudinal evolution of inspiratory muscle strength in ALS patients
Time Frame: 2012-2016
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inspiratory muscle strength (in cmH2O) will be assessed at each trimestrial visit
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2012-2016
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jean-Paul Janssens, MD, University Hospital, Geneva
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NAC 11-062R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Amyotrophic Lateral Sclerosis
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