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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04686110
Other study ID # 2020-AO3395-34
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 12, 2021
Est. completion date February 2023

Study information

Verified date October 2021
Source University Hospital, Angers
Contact Attachée de Recherche Clinique
Phone 0241353637
Email jeanne.muller@chu-angers.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Amyotrophic Lateral Sclerosis, or Charcot's disease, is a neurodegenerative disease affecting motor neurons. The disease affects between 5 and 10 people per 100,000 in the world, nearly 7,000 patients are affected in France. The only therapeutic treatment available to date in France is riluzole, which slows the progression of the disease. Amyotrophic Lateral Sclerosis is the first degenerative disease affecting motor neurons. However, recent evidence suggests that the impairment extends beyond motor neurons alone. Optical Coherence Tomography analyzes made it possible to highlight ophthalmologic damage in patients with Amyotrophic Lateral Sclerosis, in particular at the macula and papilla, although some results are contradictory. No angiographic Optical Coherence Tomography analysis has been performed to date in patients with Amyotrophic Lateral Sclerosis. However, in the hypothesis of microvascular involvement participating in the pathophysiology of neurodegeneration in Amyotrophic Lateral Sclerosis, these examinations could provide relevant clinical and pathophysiological data by studying the retinal microvascularization of patients with the disease.


Recruitment information / eligibility

Status Recruiting
Enrollment 94
Est. completion date February 2023
Est. primary completion date February 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Patient Amyotrophic Lateral Sclerosis : - Patient diagnosed with bulbar or spinal ALS defined according to El Escorial criteria (probable or certain) - Hospitalized in a day hospital at the Angers University Hospital as part of his usual follow-up Control subject : - Subject not affected by the disease studied and without a history of neurological disease. - Subject matched in age and sex to a case (patient) For all participants: - Major upon inclusion - Signature of informed consent to participate in the protocol Exclusion Criteria: Patient Amyotrophic Lateral Sclerosis and control subject : - Simultaneous participation in another intervention protocol with an experimental treatment - Subject unable to express consent - Known ophthalmologic pathology (maculopathy, glaucoma, optic neuropathy, retinopathy whatever the etiology) - Diabetic subject - Cardiovascular history - Inability to perform the ophthalmological examinations of the study - Pregnant, lactating or parturient woman - Subject under duress psychiatric care - Subject to legal protection - Subject not affiliated or not beneficiary of a social security scheme

Study Design


Intervention

Other:
angiographic optical coherence tomography
angiographic optical coherence tomography

Locations

Country Name City State
France CHU Angers Angers

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Compare the angiographic optical coherence tomography examination in patients with ALS in comparison with healthy controls Compare the angiographic optical coherence tomography examination in patients with ALS in comparison with healthy controls at inclusion
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