Amyotrophic Lateral SclerosisNCT03536962
Multidisciplinary Follow-up of Patients With Amyotrophic Lateral Sclerosis
An observational study of Amyotrophic Lateral Sclerosis, run by Ruxandra Iancu Ferfoglia at 1 site in Switzerland.
Trial summary
Analyse a multidisciplinary follow-up of amyotrophic lateral sclerosis patients, monitored through a Cohort study at Geneva University Hospitals. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2012to 1 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients living in the Geneva area suffering from Amyotrophic Lateral Sclerosis or related disorders
Who may be able to join
- Amyotrophic Lateral Sclerosis fulfilling the El Escorial criteria (definite, probable, possible), primary lateral sclerosis, progressive muscular atrophy, progressive bulbar palsy
Who cannot join
- Patients with other neurological diagnoses than mentioned in the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cohort Study: Multidisciplinary Follow-up of Patients With Amyotrophic Lateral Sclerosis
Analyse a multidisciplinary follow-up of amyotrophic lateral sclerosis patients, monitored through a Cohort study at Geneva University Hospitals.
Read the 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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- no intervention
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2012-2016
Secondary outcomes (4)
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)
Measured: 2012-2016
Longitudinal evolution of pulmonary function in ALS patients
Vital capacity(in Liters) will be assessed at each trimestrial visit
Measured: 2012-2016
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
Measured: 2012-2016
Longitudinal evolution of inspiratory muscle strength in ALS patients
inspiratory muscle strength (in cmH2O) will be assessed at each trimestrial visit
Measured: 2012-2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start1 Jun 2012
- Primary completion1 Sep 2016
- Study completion1 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruxandra Iancu Ferfoglia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ruxandra Iancu Ferfoglia, University Hospital, Geneva
- Investigators
- Jean-Paul Janssens, MD, Study chair, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536962
- Sponsor's protocol ID
- NAC 11-062R
- Status last verified
- Apr 2018
- First submitted
- 14 Jan 2018
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study: Multidisciplinary Follow-up of Patients With Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT03536962
- Acronym / sponsor ID
- NAC 11-062R
- Conditions
- Amyotrophic Lateral Sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ruxandra Iancu FerfogliaUniversity, hospital or other
- Study start
- 1 Jun 2012 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 Oct 2018 (estimated)
- First posted
- 25 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients living in the Geneva area suffering from Amyotrophic Lateral Sclerosis or related disorders
Key inclusion criteria (1 listed)
- Amyotrophic Lateral Sclerosis fulfilling the El Escorial criteria (definite, probable, possible), primary lateral sclerosis, progressive muscular atrophy, progressive bulbar palsy
Key exclusion criteria (1 listed)
- Patients with other neurological diagnoses than mentioned in the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
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
4 secondary outcomes
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
Longitudinal evolution of pulmonary function in ALS patients
Time frame: 2012-2016
Evolution of body mass composition measured by the Body Mass Index in ALS patients
Time frame: 2012-2016
Longitudinal evolution of inspiratory muscle strength in ALS patients
Time frame: 2012-2016
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
- Link to multidisciplinary consultation for motorneurone diseaseLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Paul Janssens, MD study chair
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis, run by Ruxandra Iancu Ferfoglia at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal change of the revised Amyotrophic Lateral Sclerosis Functional rating scale in Amyotrophic Lateral Sclerosis patients (time frame: 2012-2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2018.