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Tears may hold key to ALS diagnosis, small study suggests

NCT ID NCT04953286

Diagnosis Sponsor: University Hospital, Tours Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether chemicals in tears and eye surface cells can help diagnose amyotrophic lateral sclerosis (ALS) or predict how the disease will progress. Researchers collected tear samples and performed eye exams on 55 people with ALS and healthy controls. The goal was to see if the tear 'metabolome' and 'lipidome' could distinguish ALS patients from others, potentially leading to a simple, non-invasive diagnostic tool.

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 successful, this could lead to a simple, non-invasive diagnostic test for ALS using tears, helping with earlier detection and monitoring.
What could go wrong
This is a small, completed observational study with only 55 participants. The findings are exploratory and need much larger trials to confirm if tear biomarkers are reliable for diagnosis or prognosis.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

55 people

The number who actually took part.

Started

Sep 2021

Finished

Sep 2023

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.

Ages

18 to 100 years

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.

Case group selection criteria : Inclusion Criteria: * Patient with clinically defined or probable primary ALS according to Airlie House criteria(1) * Familial or sporadic form * ≥18 years of age * Patient affiliated with a social security plan * Informed consent signed by the patient Exclusion Criteria: * Motor neuron disease mimicking ALS * Pregnant or breastfeeding woman * Treatment that may have a neuroprotective effect * Any eye drops or treatments that may interfere with tear production * Lens wearer * Eye surgery ≤3 months * Any ocular pathology other than ametropia, oculomotor disorder, amblyopia * Any general pathology other than ALS with ocular repercussions * Protective measure of guardianship or curators Control group selection criteria: Inclusion Criteria: * No diagnosed neurological pathology * ≥18 years of age * Patient affiliated with a social security plan * Informed consent signed by the participant Exclusion Criteria: * Pregnant or breastfeeding woman * Treatment likely to have a neuroprotective effect * Any eye drops or treatments that may interfere with tear production * Lens wearer * Eye surgery ≤3 months * Any ocular pathology except ametropia, oculomotor disorder, amblyopia * Any general pathology with ocular repercussions * Protective measure of guardianship or curator

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis Lacerations

As listed by the trial registrant

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

Amyotrophic lateral sclerosis

Contacts and locations

Locations

  • Centre d'Investigation Clinique_CIC 1415

    Tours, France

  • Neurology Department, University Hospital of Tours, France

    Tours, 37044, France

  • Ophthalmology Department, University Hospital of Tours, France

    Tours, 37000, France

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