Clinical trial NCT03536962: Multidisciplinary Follow-up of Patients With Amyotrophic Lateral Sclerosis
Official title: Cohort Study: Multidisciplinary Follow-up of Patients With Amyotrophic Lateral Sclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2018-05-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients living in the Geneva area suffering from Amyotrophic Lateral Sclerosis or related disorders

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.

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

Primary outcomes:
measure: Longitudinal change of the revised Amyotrophic Lateral Sclerosis Functional rating scale in Amyotrophic Lateral Sclerosis patients
timeFrame: 2012-2016
Secondary outcomes:
measure: Correlation of walking speed measured by Timed Up and Go test and the Amyotrophic Lateral Sclerosis Functional rating scale (ALSFRS-R)
timeFrame: 2012-2016
measure: Longitudinal evolution of pulmonary function in ALS patients
timeFrame: 2012-2016
measure: Evolution of body mass composition measured by the Body Mass Index in ALS patients
timeFrame: 2012-2016
measure: Longitudinal evolution of inspiratory muscle strength in ALS patients
timeFrame: 2012-2016
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospital
Study officials:
affiliation: University Hospital, Geneva
name: Jean-Paul Janssens, MD
role: STUDY_CHAIR
References: