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Prognostic Value of a Diaphragmatic Endurance Test in Patients With Amyotrophic Lateral Sclerosis (SLA)

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ClinicalTrials.gov Identifier: NCT02528071
Recruitment Status : Recruiting
First Posted : August 19, 2015
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief Summary:

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease which involves respiratory muscles and can lead at short term to respiratory failure. The occurrence of respiratory failure is associated with morbidity and an increased mortality. To date, respiratory muscle weakness is predicted from the reduction of vital capacity, maximal inspiratory force, nocturnal symptoms and hypercapnia. Even taken together, the predictive value of these indices is low.

The investigators hypothesize that an endurance test of diaphragmatic work would be more sensitive to respiratory muscle involvement than maximal respiratory force.

Consequently, the investigators assessed diaphragmatic performance through an isocapnic hyperventilation test (IHT) in patients at the onset of ALS and, then regularly up to the occurrence of respiratory failure. The investigators make the hypothesis that IHT will be altered earlier than maximal inspiratory force


Condition or disease Intervention/treatment
ALS (Amyotrophic Lateral Sclerosis) Other: Diaphragmatic endurance test

Study Type : Observational
Estimated Enrollment : 165 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Value of a Diaphragmatic Endurance Test in Patients With Amyotrophic Lateral Sclerosis : Impact and Prognosis. Single-center Prospective Pilot Study
Actual Study Start Date : September 29, 2014
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021


Group/Cohort Intervention/treatment
Patients
ALS patients performing measurements of maximal respiratory forces, diaphragmatic endurance during a diaphragmatic endurance test and phrenic nerve activity at the onset of the disease and repeated every 3 months up to respiratory failure or death
Other: Diaphragmatic endurance test
This consists of hyperventilation in a flask while maintaining the constant level of Carbon Dioxide (CO2). The patient will realize hyperventilation to increasing levels of Maximum Minute Ventilation (MMV), corresponding to increasing levels of respiratory rate, until exhaustion

Control
Healthy controls performing measurements of maximal respiratory forces, diaphragmatic endurance during a diaphragmatic endurance test and phrenic nerve activity. This arm will enable to establish reference values of IHT
Other: Diaphragmatic endurance test
This consists of hyperventilation in a flask while maintaining the constant level of Carbon Dioxide (CO2). The patient will realize hyperventilation to increasing levels of Maximum Minute Ventilation (MMV), corresponding to increasing levels of respiratory rate, until exhaustion




Primary Outcome Measures :
  1. Endurance time [ Time Frame: Day 1 ]
    Difference in endurance time during the IHT between healthy controls and ALS patients when diagnosis is established


Secondary Outcome Measures :
  1. Reference values of the diaphragmatic endurance test [ Time Frame: Day 1 ]
    Reference values of the diaphragmatic endurance test in healthy controls according to age, by 10 years range.

  2. Reference values of phrenic nerve activity [ Time Frame: Day 1 ]
    Reference values of phrenic nerve activity in healthy controls according to age. It is measured with diaphragmatic Electromyogram by cervical electrical stimulation.

  3. Slope of endurance time decrease [ Time Frame: At Day 1 and every 3 months of follow-up (3 years) ]
    Slope of endurance time decrease with time in ALS patients measured during IHT

  4. Amplitude of phrenic nerve [ Time Frame: At Day 1 and every 3 months of follow-up (3 years) ]
    It is the relationship between phrenic nerve activity and diaphragmatic endurance in ALS patients

  5. Latency of phrenic nerve [ Time Frame: At Day 1 and every 3 months of follow-up (3 years) ]
    It is the relationship between phrenic nerve activity and diaphragmatic endurance in ALS patients



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with ALS Healthly volonteers
Criteria

Inclusion Criteria for Patients :

  • Older than 18 years old and younger than 80 years old
  • ALS patient seen during the diagnostic assessment

Inclusion Criteria for control group :

  • Older than 25 years old and younger than 80 years old
  • No respiratory or neurologic active pathology

Exclusion Criteria for Patients :

  • Bulbar ALS (inability to perform maximal respiratory maneuvers)
  • Dementia
  • Respiratory failure at diagnosis (arterial carbon dioxide partial pressure (pCO2) > 45 mmHg)
  • Respiratory or neurologic active pathology

Exclusion Criteria for control group :

  • Chest wall deformation with spirometric defect

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02528071


Contacts
Contact: Isabelle COURT-FORTUNE, MD (0)477828314 ext +33 isabelle.court-fortune@chu-st-etienne.fr
Contact: Arnauld GARCIN, CRA (0)477120286 ext +33 arnauld.garcin@chu-st-etienne.fr

Locations
France
CHU de SAINT-ETIENNE Recruiting
Saint-etienne, France, 42000
Principal Investigator: Isabelle COURT-FORTUNE, MD         
Sub-Investigator: Jean-Christophe ANTOINE, MD PhD         
Sub-Investigator: Jean-Philippe CAMDESSANCHE, MD PhD         
Sub-Investigator: Jean-Claude BARTHELEMY, MD PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Study Chair: Frederic COSTES, MD PhD CHU de CLERMONT-FERRAND
Principal Investigator: Isabelle COURT-FORTUNE, MD CHU de Saint-Etienne

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02528071     History of Changes
Other Study ID Numbers: 1308188
2014-A00309-38 ( Other Identifier: ANSM )
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Amyotrophic Lateral Sclerosis
ALS
Diaphragmatic Endurance Test

Additional relevant MeSH terms:
Sclerosis
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases