Analysis of Capillary Retinal and Papillary Vascularization in Patients With Amyotrophic Lateral Sclerosis - CAPISLA

Not Applicable

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Other: angiographic optical coherence tomography

• Registration Number: NCT04686110
• Lead Sponsor: University Hospital, Angers

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-28
• Study Start: 2021-02-12
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-07
• Last Update Posted: 2021-10-08
• Primary Completion: 2023-02
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 94

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control subjects	angiographic optical coherence tomography	-
Patients Amyotrophic Lateral Sclerosis	angiographic optical coherence tomography	-

Primary Outcome Measures

Name	Time	Method
Compare the angiographic optical coherence tomography examination in patients with ALS in comparison with healthy controls	at inclusion	Compare the angiographic optical coherence tomography examination in patients with ALS in comparison with healthy controls

Trial Locations

Locations (1)

CHU Angers; 🇫🇷 Angers, France