RecruitingOBSERVATIONAL

Contribution of Diaphragmatic Ultrasound for Monitoring Diaphragmatic Function in Patients With Amyotrophic Lateral Sclerosis

This study is exploring how a special type of ultrasound scan on the diaphragm – your main breathing muscle – could help people living with Amyotrophic Lateral Sclerosis (ALS). ALS can weaken the breathing muscles, leading to respiratory problems. Currently, tests to check breathing are sometimes hard to do or only spot problems once they're more advanced. This research hopes to find out if diaphragmatic ultrasound, which is a simple, safe scan, can detect these changes earlier. The goal is to see if this scan can accurately predict when someone might need breathing support (like a special mask to help them breathe), helping them get the right care at the right time. This could improve their quality of life and potentially help them live longer.

At a glance

Status

Recruiting

Sponsor

Centre Hospitalier Universitaire Dijon

Enrolment target

Start

16 May 2023

Estimated completion

01 Nov 2028

Amyotrophic Lateral Sclerosis

What is this study about?

Amyotrophic Lateral Sclerosis (ALS) is a condition that affects the nerve cells in your brain and spinal cord, leading to muscle weakness over time. One of the most important muscles that can be affected is your diaphragm, which is the main muscle you use to breathe. When the diaphragm weakens, it can make breathing difficult. Currently, doctors use a few tests to check how well your breathing muscles are working, but these can sometimes be difficult or uncomfortable to do, especially for people with ALS. Also, these tests might only show up breathing problems when they are already quite noticeable.

This study aims to find a better, simpler way to monitor breathing muscle function in people with ALS. The researchers are particularly interested in using a special ultrasound scan of the diaphragm. Ultrasound scans use sound waves to create pictures of your body's inside, similar to how they're used to look at babies during pregnancy. This type of scan is safe, quick, doesn't use radiation, and is usually quite readily available. Doctors are keen to see if this specific ultrasound can spot early changes in the diaphragm that might indicate breathing problems are starting.

The main goals of this research are to understand how the diaphragm changes over time when viewed with ultrasound, to see if these ultrasound measurements match up with other breathing tests, and most importantly, to find out if the ultrasound can predict when someone with ALS might need help with their breathing (called non-invasive ventilation, or NIV). If this ultrasound can provide an early warning, it could help doctors introduce breathing support at the best possible time, potentially improving quality of life and helping people live longer. This could make a real difference in managing ALS.

Key takeaways

This study explores using a simple ultrasound to monitor breathing in ALS.
It aims to detect breathing problems earlier than current methods.
The goal is to help doctors decide the best time to start breathing support.
Diaphragmatic ultrasound is safe, quick, and uses no radiation.
Participation involves regular scans and breathing tests over about a year.
This research hopes to improve quality of life for people with ALS.

Who may be eligible?

To join this study, you need to be an adult with a diagnosis of Amyotrophic Lateral Sclerosis (ALS). Your doctor would have confirmed your ALS diagnosis using specific medical criteria. Importantly, you must not currently need or be using breathing support like a non-invasive ventilator (NIV) for a pre-existing breathing problem related to your diaphragm.

There are also a few practical requirements: you need to be able to speak and read French, and be covered by national health insurance in France. You also can't be pregnant, breastfeeding, or in a situation where your freedom is restricted, such as being in prison or under certain legal protection measures like guardianship.

The research team will review your medical information to make sure this study is right for you and that you meet all the necessary criteria. They will discuss everything with you thoroughly before you decide whether to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have a confirmed diagnosis of ALS?
Am I an adult (18 years or older)?
Am I currently NOT using breathing support (like a ventilator) due to existing diaphragm problems?
Do I speak and read French?
Does my doctor think this study is suitable for me?

Answer every question to see your result.

What does participation involve?

The detailed involvement for this specific study isn't fully explained in the summary provided. However, based on the goals to monitor diaphragm changes, participation would likely involve regular visits to a clinic or hospital where the diaphragmatic ultrasound scans would be performed. You would also have other breathing tests, such as those measuring lung capacity and oxygen levels, at these visits. The study mentions needing to track changes over 6 and 12 months, so you would likely have several follow-up appointments during that period. You would not receive any new or experimental medications as part of this study, as it focuses on a diagnostic tool (ultrasound) rather than a treatment. The total duration of your participation would be at least 12 months, with multiple clinic visits spaced out over that time.

Potential risks and benefits

Taking part in this study could offer some potential benefits, as it might lead to a better understanding of how to monitor breathing in ALS, which could eventually improve care for future patients. For you personally, participating means you would receive close monitoring of your breathing function. Regarding risks, diaphragmatic ultrasound is a very safe procedure; it's non-invasive, doesn't use radiation, and generally has no side effects. The other breathing tests are standard medical procedures and carry minimal risks, mostly involving mild discomfort or effort. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Chu Dijon Bourogne
Verified postcode
Dijon, France· Recruiting

Common questions

What is ALS?

ALS, or Amyotrophic Lateral Sclerosis, is a condition that affects nerve cells, leading to muscle weakness and problems with movement, speaking, and breathing over time.

What is the diaphragm?

The diaphragm is a sheet of muscle just below your lungs. It's your main breathing muscle, and it moves up and down to help you take air in and out.

What is diaphragmatic ultrasound?

It's a special type of scan that uses sound waves to look at your diaphragm muscle. It's safe, painless, and doesn't use any radiation, similar to a scan used during pregnancy.

Why is this study important?

It aims to find a simpler and earlier way to detect breathing problems in people with ALS, which could help them get breathing support at the best possible time and improve their care.

Will I get new medicine in this study?

No, this study is about checking breathing with a special scan, not about testing new medications. It's focused on finding a better way to monitor your breathing.

How to find out more

Marjolaine GEORGES

marjolaine.georges@chu-dijon.fr 03.80.29.37.72 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.