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Amyotrophic Lateral Sclerosis (ALS)EchoDiaNCT07170865

Dynamic Impact of NIV on Diaphragmatic Ultrasound in Patients With Amyotrophic Lateral Sclerosis

An observational study of Amyotrophic Lateral Sclerosis (ALS) and Non Invasive Ventilation (NIV), run by University Hospital, Grenoble at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this pilot observational study is to learn about the dynamic impact of the non invasive ventilation on the diaphragm in patient with amyotrophic lateral sclerosis. The main question it aims to answer : can diaphragmatic ultrasound detect differences in diaphragmatic motion (diaphragmactic excursion and… Read more about this study

Who is it for?
Ages 18 years and older
How many people
20 participants
Where
1 siteFrance
Study dates
1 Sep 2025to 15 Oct 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Diagnosis of bulbar or spinal amyotrophic lateral sclerosis (ALS) established by a neurologist

Who may be able to join

  • Adult patient (≥18 years old)
  • Diagnosis of bulbar or spinal amyotrophic lateral sclerosis (ALS) established by a neurologist
  • Indication for non-invasive ventilation (NIV) confirmed by the referring pulmonologist for daytime and/or nocturnal alveolar hypoventilation

Who cannot join

  • Continuous (24-hour) non-invasive ventilation
  • Patient refusal to participate
  • Individual under legal guardianship or judicial protection

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Christel Saint Raymond, Doctor contact

+33 4 76 76 54 53

CSaint-raymond@chu-grenoble.fr

Hugo Vanderstraete, Resident contact

+33 6 78 34 08 51

hvanderstraete@chu-grenoble.fr

France1 site

  • CHU Grenoble-Alpes

    Grenoble, Isère, 38043

    Christel Saint Raymond, Doctor, +33 4 76 76 54 53, CSaint-raymond@chu-grenoble.fr

    Hugo Vanderstraete, +33 6 78 34 08 51, hvanderstraete@chu-grenoble.fr

Other trials in France

About this study

Official title: Assessment of the Dynamic Impact of Non-Invasive Ventilation on Diaphragmatic Ultrasound in Patients With Amyotrophic Lateral Sclerosis

The goal of this pilot observational study is to learn about the dynamic impact of the non invasive ventilation on the diaphragm in patient with amyotrophic lateral sclerosis. The main question it aims to answer : can diaphragmatic ultrasound detect differences in diaphragmatic motion (diaphragmactic excursion and diaphragmatic thickening between spontaneous breathing and non-invasive ventilation ?

Participants will receive diaphragmatic ultrasound assessments both under spontaneous breathing and during non-invasive ventilation on their day hospital evaluation for ventilatory support.

Read the detailed description

Each diaphragmatic ultrasound assessment will be performed on both the right and left hemidiaphragms, with the patient in a semi-recumbent position at 30°, during a maximal inspiratory effort. The following parameters will be measured:

  • Diaphragmatic excursion using M-mode ultrasound with a low-frequency convex (abdominal) probe via a subcostal approach
  • Diaphragmatic thickening using B-mode ultrasound with a high-frequency linear (vascular) probe via the lateral axillary line

Measurements will be obtained during spontaneous breathing and after 10 to 20 minutes of non-invasive ventilation (NIV), using ventilator settings deemed optimally adjusted by the supervising physician.

Keywords
Amyotrophic Lateral Sclerosis (ALS), Non invasive ventilation (NIV), Diaphragmatic ultrasound, diaphragmatic excursion, ultrasound, diaphragmatic thickening
Medical subject headings
Amyotrophic Lateral Sclerosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite : - Diaphragmatic excursion variation (DE) - Diaphragmatic thickening variation (DT)

    Both DE and DT will be measured under spontaneous bretahing and under NIV. The outcomes will be compared, and the percentage variation between the two conditions will be recorded

    Measured: Day 1

Secondary outcomes (4)

  1. Changes in transcutaneous carbon dioxide (TcCO₂) levels

    The variation in TcCO₂ will be measured and compared with the variations in DE and DT to determine whether there is a correlation.

    Measured: Day 1

  2. NIV Tolerance

    NIV tolerance will be assessed using a numerical subjective scale from 0 to 10. The tolerance numercial scale will then be compared with variations in DE and DT to determine whether there is a correlation.

    Measured: Day 1

  3. Pathophysiological type of ALS

    For each patient, the bulbar type or the spinal type of ALS will be recorded. Subgroups analyses between spinal ALS and bulbar ALS. Some differences are to be expected.

    Measured: Day 1

  4. Adherence of NIV

    If a NIV is already instaured, the average adherence in hours per 24 hours will be recorded

    • Subgroupes analyses between < 8 hours/24h NIV adherence, and 8 hours/24h or more NIV adherence

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion15 Sep 2026 (estimated)
  4. Study completion15 Oct 2026 (estimated)

Resources

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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07170865
Sponsor's protocol ID
38RC25.0186
Acronym
EchoDia
Status last verified
Jun 2025
First submitted
19 Aug 2025
Last updated
12 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Georges M, Perez T, Rabec C, Jacquin L, Finet-Monnier A, Ramos C, Patout M, Attali V, Amador M, Gonzalez-Bermejo J, Salachas F, Morelot-Panzini C. Proposals from a French expert panel for respiratory care in ALS patients. Respir Med Res. 2022 May;81:100901. doi: 10.1016/j.resmer.2022.100901. Epub 2022 Mar 3.

    PubMed 35378353

  • Kang HW, Kim TO, Lee BR, Yu JY, Chi SY, Ban HJ, Oh IJ, Kim KS, Kwon YS, Kim YI, Kim YC, Lim SC. Influence of diaphragmatic mobility on hypercapnia in patients with chronic obstructive pulmonary disease. J Korean Med Sci. 2011 Sep;26(9):1209-13. doi: 10.3346/jkms.2011.26.9.1209. Epub 2011 Sep 1.

    PubMed 21935278

  • Cammarota G, Sguazzotti I, Zanoni M, Messina A, Colombo D, Vignazia GL, Vetrugno L, Garofalo E, Bruni A, Navalesi P, Avanzi GC, Della Corte F, Volpicelli G, Vaschetto R. Diaphragmatic Ultrasound Assessment in Subjects With Acute Hypercapnic Respiratory Failure Admitted to the Emergency Department. Respir Care. 2019 Dec;64(12):1469-1477. doi: 10.4187/respcare.06803. Epub 2019 Aug 27.

    PubMed 31455684

  • Qian Z, Yang M, Li L, Chen Y. Ultrasound assessment of diaphragmatic dysfunction as a predictor of weaning outcome from mechanical ventilation: a systematic review and meta-analysis. BMJ Open. 2018 Oct 4;8(9):e021189. doi: 10.1136/bmjopen-2017-021189.

    PubMed 30287605

  • Marques MR, Pereira JM, Paiva JA, de Casasola-Sanchez GG, Tung-Chen Y. Ultrasonography to Access Diaphragm Dysfunction and Predict the Success of Mechanical Ventilation Weaning in Critical Care: A Narrative Review. J Ultrasound Med. 2024 Feb;43(2):223-236. doi: 10.1002/jum.16363. Epub 2023 Nov 2.

    PubMed 37915259

  • Pinto S, Alves P, Pimentel B, Swash M, de Carvalho M. Ultrasound for assessment of diaphragm in ALS. Clin Neurophysiol. 2016 Jan;127(1):892-897. doi: 10.1016/j.clinph.2015.03.024. Epub 2015 Apr 25.

    PubMed 25971723

  • Fantini R, Mandrioli J, Zona S, Antenora F, Iattoni A, Monelli M, Fini N, Tonelli R, Clini E, Marchioni A. Ultrasound assessment of diaphragmatic function in patients with amyotrophic lateral sclerosis. Respirology. 2016 Jul;21(5):932-8. doi: 10.1111/resp.12759. Epub 2016 Mar 19.

    PubMed 26994409

  • Bourke SC, Tomlinson M, Williams TL, Bullock RE, Shaw PJ, Gibson GJ. Effects of non-invasive ventilation on survival and quality of life in patients with amyotrophic lateral sclerosis: a randomised controlled trial. Lancet Neurol. 2006 Feb;5(2):140-7. doi: 10.1016/S1474-4422(05)70326-4.

    PubMed 16426990

  • Su WM, Cheng YF, Jiang Z, Duan QQ, Yang TM, Shang HF, Chen YP. Predictors of survival in patients with amyotrophic lateral sclerosis: A large meta-analysis. EBioMedicine. 2021 Dec;74:103732. doi: 10.1016/j.ebiom.2021.103732. Epub 2021 Dec 1.

    PubMed 34864363

  • Brown RH, Al-Chalabi A. Amyotrophic Lateral Sclerosis. N Engl J Med. 2017 Jul 13;377(2):162-172. doi: 10.1056/NEJMra1603471. No abstract available.

    PubMed 28700839

  • Lo Coco D, Marchese S, Pesco MC, La Bella V, Piccoli F, Lo Coco A. Noninvasive positive-pressure ventilation in ALS: predictors of tolerance and survival. Neurology. 2006 Sep 12;67(5):761-5. doi: 10.1212/01.wnl.0000227785.73714.64. Epub 2006 Aug 9.

    PubMed 16899545

  • Schenesse D, Mouillot P, Rabec C, Barnestein R, Tankere P, Giboulot M, Bonniaud P, Georges M. [Diaphragmatic ultrasonography for the pulmonologist: Technique and clinical use]. Rev Mal Respir. 2024 Jan;41(1):1-17. doi: 10.1016/j.rmr.2023.10.005. Epub 2023 Nov 18. French.

    PubMed 37980184

  • Boussuges A, Bregeon F, Blanc P, Gil JM, Poirette L. Characteristics of the paralysed diaphragm studied by M-mode ultrasonography. Clin Physiol Funct Imaging. 2019 Mar;39(2):143-149. doi: 10.1111/cpf.12549. Epub 2018 Oct 16.

    PubMed 30325572

  • Hiwatani Y, Sakata M, Miwa H. Ultrasonography of the diaphragm in amyotrophic lateral sclerosis: clinical significance in assessment of respiratory functions. Amyotroph Lateral Scler Frontotemporal Degener. 2013 Mar;14(2):127-31. doi: 10.3109/17482968.2012.729595. Epub 2012 Oct 30.

    PubMed 23110443

  • Fantini R, Tonelli R, Castaniere I, Tabbi L, Pellegrino MR, Cerri S, Livrieri F, Giaroni F, Monelli M, Ruggieri V, Fini N, Mandrioli J, Clini E, Marchioni A. Serial ultrasound assessment of diaphragmatic function and clinical outcome in patients with amyotrophic lateral sclerosis. BMC Pulm Med. 2019 Aug 27;19(1):160. doi: 10.1186/s12890-019-0924-5.

    PubMed 31455341

Questions about this trial

What is this clinical trial studying?

An observational study of Amyotrophic Lateral Sclerosis (ALS) and Non Invasive Ventilation (NIV), run by University Hospital, Grenoble at 1 site in France.

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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 12 Sep 2025. 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 France. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christel Saint Raymond, Doctor (+33 4 76 76 54 53, CSaint-raymond@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite : - Diaphragmatic excursion variation (DE) - Diaphragmatic thickening variation (DT) (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07170865, which also lists 17 linked publications.

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 12 Sep 2025.

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