Developing New Ways to Detect Respiratory Impairment Early in ALS
Early Detection of Respiratory Impairments in ALS: A Novel Diagnostic Approach
- Amyotrophic Lateral Sclerosis (ALS)
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Thomas Jefferson University
- Enrolment target
- 70
- Started
- September 2026
- Main results due
- 31 March 2028
- Study sites
- 1
- Registry updated
- 28 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- Healthy volunteers can take part.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
The goal of this observational study is to develop new ways to detect early changes associated with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. The study will examine whether changes in breathing, magnetic resonance imaging (MRI) of the brainstem and spinal cord, and blood markers can identify early signs of ALS before major physical changes occur.
The main questions the study aims to answer are:
* Can changes in automatic breathing help identify early ALS-related changes? * Can breathing measures distinguish people with ALS from people without ALS? * Do people with genetic risk for ALS who show changes in breathing also have changes in the brainstem and spinal cord or higher levels of blood markers associated with nerve damage?
Participants will complete breathing and muscle function tests, an MRI scan of the brainstem and spinal cord, and blood testing. The study will include people with ALS, people with genetic risk for ALS who do not yet have symptoms, and healthy adults for comparison.
Study sites(1)
Thomas Jefferson University - Center City
Philadelphia, Pennsylvania, United States
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07844590. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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