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

ALS (Amyotrophic Lateral Sclerosis) Clinical Trial

— SLA  

Official title:

Prognostic Value of a Diaphragmatic Endurance Test in Patients With Amyotrophic Lateral Sclerosis : Impact and Prognosis. Single-center Prospective Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02528071
• Other study ID #: 1308188
• Secondary ID: 2014-A00309-38
• Status: Terminated
• Start date: September 29, 2014
• Est. completion date: October 28, 2020

Study information

• Verified date: December 2020
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 136
• Est. completion date: October 28, 2020
• Est. primary completion date: October 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• ALS (Amyotrophic Lateral Sclerosis)
• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
France	CHU de SAINT-ETIENNE	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endurance time	Difference in endurance time during the IHT between healthy controls and ALS patients when diagnosis is established	Day 1
Secondary	Reference values of the diaphragmatic endurance test	Reference values of the diaphragmatic endurance test in healthy controls according to age, by 10 years range.	Day 1
Secondary	Reference values of phrenic nerve activity	Reference values of phrenic nerve activity in healthy controls according to age. It is measured with diaphragmatic Electromyogram by cervical electrical stimulation.	Day 1
Secondary	Slope of endurance time decrease	Slope of endurance time decrease with time in ALS patients measured during IHT	At Day 1 and every 3 months of follow-up (3 years)
Secondary	Amplitude of phrenic nerve	It is the relationship between phrenic nerve activity and diaphragmatic endurance in ALS patients	At Day 1 and every 3 months of follow-up (3 years)
Secondary	Latency of phrenic nerve	It is the relationship between phrenic nerve activity and diaphragmatic endurance in ALS patients	At Day 1 and every 3 months of follow-up (3 years)