Multidisciplinary Follow-up of Patients With Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Cohort Study: Multidisciplinary Follow-up of Patients With Amyotrophic Lateral Sclerosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03536962
• Other study ID #: NAC 11-062R
• Status: Active, not recruiting
• Start date: June 1, 2012
• Est. completion date: October 1, 2018

Study information

• Verified date: April 2018
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: October 1, 2018
• Est. primary completion date: September 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
Switzerland	Geneva University Hospital	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Ruxandra Iancu Ferfoglia

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Longitudinal change of the revised Amyotrophic Lateral Sclerosis Functional rating scale in Amyotrophic Lateral Sclerosis patients	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	2012-2016
Secondary	Correlation of walking speed measured by Timed Up and Go test and the Amyotrophic Lateral Sclerosis Functional rating scale (ALSFRS-R)	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)	2012-2016
Secondary	Longitudinal evolution of pulmonary function in ALS patients	Vital capacity(in Liters) will be assessed at each trimestrial visit	2012-2016
Secondary	Evolution of body mass composition measured by the Body Mass Index in ALS patients	the Body Mass Index (kg/m2), will be assessed at each trimestrial visit	2012-2016
Secondary	Longitudinal evolution of inspiratory muscle strength in ALS patients	inspiratory muscle strength (in cmH2O) will be assessed at each trimestrial visit	2012-2016

External Links

•   Link to multidisciplinary consultation for motorneurone disease