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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02528071
Date of registration:	18/08/2015
Prospective Registration:	No
Primary sponsor:	Centre Hospitalier Universitaire de Saint Etienne
Public title:	Prognostic Value of a Diaphragmatic Endurance Test in Patients With Amyotrophic Lateral Sclerosis SLA
Scientific title:	Prognostic Value of a Diaphragmatic Endurance Test in Patients With Amyotrophic Lateral Sclerosis : Impact and Prognosis. Single-center Prospective Pilot Study
Date of first enrolment:	September 29, 2014
Target sample size:	165
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT02528071
Study type:	Observational
Study design:
Phase:

Countries of recruitment
France

Contacts

Name:	Isabelle COURT-FORTUNE, MD
Address:
Telephone:
Email:
Affiliation:	CHU de Saint-Etienne

Name:	Isabelle COURT-FORTUNE, MD
Address:
Telephone:	(0)477828314
Email:	isabelle.court-fortune@chu-st-etienne.fr
Affiliation:

Name:	Frederic COSTES, MD PhD
Address:
Telephone:
Email:
Affiliation:	CHU de CLERMONT-FERRAND

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

ALS (Amyotrophic Lateral Sclerosis)

Intervention(s)

Other: Diaphragmatic endurance test

Primary Outcome(s)

Endurance time [Time Frame: Day 1]

Secondary Outcome(s)

Reference values of the diaphragmatic endurance test [Time Frame: Day 1]

Latency of phrenic nerve [Time Frame: At Day 1 and every 3 months of follow-up (3 years)]

Reference values of phrenic nerve activity [Time Frame: Day 1]

Amplitude of phrenic nerve [Time Frame: At Day 1 and every 3 months of follow-up (3 years)]

Slope of endurance time decrease [Time Frame: At Day 1 and every 3 months of follow-up (3 years)]

Secondary ID(s)

1308188

2014-A00309-38

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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