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Breathing tests may reveal ALS before symptoms strike

NCT ID NCT07844590

Diagnosis Sponsor: Thomas Jefferson University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 28, 2026 · Last updated Sep 29, 2026 · Updated 1 time

Summary

Researchers at Thomas Jefferson University are studying new ways to detect early changes linked to ALS, also called Lou Gehrig's disease. The study enrolls people with ALS, people who carry ALS-related genes but have no symptoms, and healthy adults. Participants complete breathing and muscle tests, an MRI of the brainstem and spinal cord, and blood tests. The goal is to see whether a breathing-based risk score, imaging, and blood markers can spot ALS-related nerve damage earlier than standard exams.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If the breathing score works, doctors could detect ALS-related nerve damage earlier, when treatments may help more. It could also flag people with ALS genes who are not yet sick.
What could go wrong
This is a small observational study, so the breathing score may not prove accurate enough to use in clinics. It cannot show whether early detection changes outcomes, and MRI and blood markers may not line up with breathing changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will include adults with symptomatic ALS, asymptomatic or presymptomatic individuals with genetic variants associated with ALS, and healthy age- and sex-matched controls. Participants with ALS or genetic risk for ALS will be recruited from Thomas Jefferson University and other ALS patient inventories and referral sources.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Symptomatic participants with ALS must have an ALS Functional Rating Scale-Revised (ALSFRS-R) score of 47/48 or less at the time of recruitment. * Asymptomatic/presymptomatic participants must have a pathogenic C9orf72 expansion of at least 25 repeats or a similar genetic abnormality known to be associated with ALS. * Healthy control participants must have no clinically identifiable neurological deficits based on medical history and screening. - Exclusion Criteria: * Any safety concern or contraindication to MRI based on MRI safety screening. * Healthy control participants who do not pass the neurological screening. * Pregnancy. * Metal implants above the waist, including cardiac pacemakers or brain, neck, cervical, or thoracic implants. * Neurocognitive impairment. * Inability or unwillingness to provide informed consent. * Younger than 18 years of age.

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis Charcot-Marie-Tooth disease type 1F disease Hypercapnia Hypoxia motor neuron disorder Respiratory Aspiration respiratory failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amyotrophic lateral sclerosis (ALS)

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Thomas Jefferson University - Center City

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

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