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Completed

NCT Number: NCT04953286

Ocular Surface Metabolo-lipidomics in Lateral Amyotrophic Sclerosis

Amyotrophic Lateral Sclerosis (ALS) is the most common neurodegenerative disease affecting the motor neuron. Currently, there is no diagnostic test and no examination that can predict the evolution of this pathology. The search for diagnostic and prognostic biomarkers is therefore essential for a better understanding of the pathophysiology of ALS, which remains poorly understood, and also for better clinical management. The ocular surface, made up of liquid elements, tears, and cells, is an accessible anatomical-physiological entity that has demonstrated its usefulness in the identification of biomarkers in neurodegenerative diseases such as Parkinson's or Alzheimer's. To date, no study has explored the ocular surface as a biomarker in ALS

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Lacerations Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies Wounds and Injuries

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre d'Investigation Clinique_CIC 1415, Tours, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measure of visual acuity

Other

ETDRS and Parinaud scale

Interferometry

Other

Non-contact exam measuring N.I.B.U.T (Non-invasive break-up time), quantitative and qualitative evaluation of the meibomian glands and quantitative evaluation of the tear meniscus

Samples of basal tears

Other

Collection of basal tears without instillation of anesthetic with a Schirmer strip for 5 minutes and by microcapillary

Central corneal sensitivity

Other

Central corneal sensitivity using a Cochet-Bonnet esthesiometer (Luneau©)

Slit lamp examination and undilated fundus

Other

Slit lamp examination and undilated fundus

Conjunctival impression

Other

Conjunctival impression with anesthetic instillation

Evaluation of the corneal innervation

Other

Contact corneal confocal microscopy

Primary outcomes

  1. Metabolome profile in tears for the diagnosis and prognosis of ALS.

    Time frame: Baseline

    Once the composition in metabolites (i.e. tear metabolome) is determined, statistical univariate and multivariate analyses will aim to determine if the tear metabolome can cluster ALS patients and controls and therefore can be used as a diagnosis biomarker

  2. Metabolome profile in intra-cellular contents for the diagnosis and prognosis of ALS.

    Time frame: Baseline

    Once the composition in metabolites in conjunctival cells is determined, statistical univariate and multivariate analyses will aim to determine if the tear metabome can cluster ALS patients and controls and therefore can be used as a diagnosis biomarker.

  3. Lipidome profile in tears for the diagnosis and prognosis of ALS.

    Time frame: Baseline

    Once the composition in lipids (i.e. tear lipidome) is determined, statistical univariate and multivariate analyses will aim to determine if the tear lipidome can cluster ALS patients and controls and therefore can be used as a diagnosis biomarker

  4. Lipidome profile in intra-cellular contents for the diagnosis and prognosis of ALS.

    Time frame: Baseline

    Once the composition in lipids in conjunctival cells is determined, statistical univariate and multivariate analyses will aim to determine if the tear lipidome can cluster ALS patients and controls and therefore can be used as a diagnosis biomarker.

Secondary outcomes

  1. Evolution of the ocular surface metabolites during ALS progression using ultra-high performance liquid chromatography coupled with mass spectrometry

    Time frame: Baseline

    By carrying out a longitudinal analysis in ALS cases, the modification in tear and cells metabo-lipidome will be assessed at three time-points (at diagnosis, at month 3 and 6) and will correlated with bioclinical criteria of ALS progression (i.e. % of weight loss, % of slope of progression of the ALS-FRS-r score and % of decrease in forced vital capacity). This analysis will aim to search for analytes that can predict ALS progression (i.e. prognosis biomarker).

  2. Evolution of the ocular surface lipids during ALS progression using ultra-high performance liquid chromatography coupled with mass spectrometry

    Time frame: Baseline

    By carrying out a longitudinal analysis in ALS cases, the modification in tear and cells metabo-lipidome will be assessed at three time-points (at diagnosis, at month 3 and 6) and will correlated with bioclinical criteria of ALS progression (i.e. % of weight loss, % of slope of progression of the ALS-FRS-r score and % of decrease in forced vital capacity). This analysis will aim to search for analytes that can predict ALS progression (i.e. prognosis biomarker).

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

Tear Fluid and Ocular Surface Metabolomics and Lipidomics in Lateral Amyotrophic Sclerosis: a Prospective Comparative Study

Acronym: LARMOMIQUE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 7, 2021
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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