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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case group | Other | The procedure, specific to the study, consists in taking samples of tears and cells at inclusion, 3 months after inclusion and 6 months after inclusion on patients with Amyotrophic Lateral Sclerosis |
|
| Control group | Other | The procedure, specific to the study, consists in taking samples of tears and cells at inclusion, 3 months after inclusion and 6 months after inclusion on patients without neurological disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measure of visual acuity | Other | ETDRS and Parinaud scale |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolome profile in tears for the diagnosis and prognosis of ALS. | 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 | Baseline |
| Metabolome profile in intra-cellular contents for the diagnosis and prognosis of ALS. | 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. | Baseline |
| Lipidome profile in tears for the diagnosis and prognosis of ALS. | 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 | Baseline |
| Lipidome profile in intra-cellular contents for the diagnosis and prognosis of ALS. | 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the ocular surface metabolites during ALS progression using ultra-high performance liquid chromatography coupled with mass spectrometry | 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). |
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Case group selection criteria :
Inclusion Criteria:
Exclusion Criteria:
Control group selection criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmology Department, University Hospital of Tours, France | Tours | 37000 | France | |||
| Neurology Department, University Hospital of Tours, France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39349171 | Result | Khanna RK, Catanese S, Mortemousque G, Dupuy C, Lefevre A, Emond P, Beltran S, Gissot V, Pisella PJ, Blasco H, Corcia P. Metabolomics of basal tears in amyotrophic lateral sclerosis: A cross-sectional study. Ocul Surf. 2024 Oct;34:363-369. doi: 10.1016/j.jtos.2024.09.005. Epub 2024 Sep 28. |
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| 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 |
|
| Baseline |
| Evolution of the ocular surface lipids during ALS progression using ultra-high performance liquid chromatography coupled with mass spectrometry | 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). | Baseline |
| Tours |
| 37044 |
| France |
| Centre d'Investigation Clinique_CIC 1415 | Tours | France |
| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| D022125 | Lacerations |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D007368 | Interferometry |
| D066167 | Slit Lamp |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D019721 | Ophthalmoscopes |
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
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