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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
angiographic optical coherence tomography
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Amyotrophic Lateral Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU AngersRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patients Amyotrophic Lateral Sclerosis

Control subjects

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 22, 2020
Last Updated
October 7, 2021
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT04686110
Brief Title
Analysis of Capillary Retinal and Papillary Vascularization in Patients With Amyotrophic Lateral Sclerosis - CAPISLA
Acronym
CAPISLA
Official Title
Analysis of Capillary Retinal and Papillary Vascularization in Patients With Amyotrophic Lateral Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 12, 2021 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients Amyotrophic Lateral Sclerosis
Arm Type
Other
Arm Title
Control subjects
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
angiographic optical coherence tomography
Intervention Description
angiographic optical coherence tomography
Primary Outcome Measure Information:
Title
Compare the angiographic optical coherence tomography examination in patients with ALS in comparison with healthy controls
Description
Compare the angiographic optical coherence tomography examination in patients with ALS in comparison with healthy controls
Time Frame
at inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Attachée de Recherche Clinique
Phone
0241353637
Email
jeanne.muller@chu-angers.fr
Facility Information:
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanne Muller
Phone
0241353637

12. IPD Sharing Statement

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

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