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Optic Coherence Tomography in Patients With Amyotrophic Lateral Sclerosis

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ClinicalTrials.gov Identifier: NCT03377868
Recruitment Status : Not yet recruiting
First Posted : December 19, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Achraf Makki, American University of Beirut Medical Center

Brief Summary:
Amyotrophic Lateral Sclerosis (ALS) is an adult-onset, devastating, neurodegenerative disease characterized by the loss of cortical, brain stem, and spinal motor neurons. Visual evoked potentials studies in patients with ALS suggest visual pathway involvement. Optic coherence tomography (OCT) is a non-invasive cross-sectional imaging modality measuring the optical reflections in biological tissues. The main objective of this observational cohort study is to explore the correlation between changes on OCT retinal parameters and and clinical disability as measured by the ALS Functional Rating Scale (ALS-FRS-r) in patients with ALS at baseline, 3 and 6 months. A secondary objective is to explore the correlation between changes in retinal OCT parameters and pulmonary function tests (FVC and FEV1) in this cohort of patients with ALS. A parallel cohort of healthy age and sex matched subjects will participate as controls to obtain reference values of their retinal layers' thickness at baseline, 3 and 6 months.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Diagnostic Test: Optic coherence tomography Diagnostic Test: Pulmonary function test Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Observational study of a cohort of patients with amyotrophic lateral sclerosis compared to a parallel cohort of healthy age and sex matched subjects
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Optic Coherence Tomography in Patients With Amyotrophic Lateral Sclerosis
Estimated Study Start Date : January 3, 2018
Estimated Primary Completion Date : July 28, 2018
Estimated Study Completion Date : September 28, 2018


Arm Intervention/treatment
Patients with Amyotrophic lateral sclerosis
Patients diagnosed with amyotrophic lateral sclerosis
Diagnostic Test: Optic coherence tomography
Optic coherence tomography measures retinal layer thickness, macular volume , and cell inner plexiform layer.

Diagnostic Test: Pulmonary function test
Pulmonary function test measures forced vital capacity and forced expiratory volume in one second.

Control
Parallel cohort of healthy age and sex matched subjects
Diagnostic Test: Optic coherence tomography
Optic coherence tomography measures retinal layer thickness, macular volume , and cell inner plexiform layer.

Diagnostic Test: Pulmonary function test
Pulmonary function test measures forced vital capacity and forced expiratory volume in one second.




Primary Outcome Measures :
  1. Change in retinal layer thickness parameters over 3 and 6 months in ALS patients [ Time Frame: 6 months ]
    Observing the change in retinal layers thickness parameters in micrometers in ALS patients from baseline to 3 and 6 months


Secondary Outcome Measures :
  1. Comparison of changes in retinal layer thickness parameters over 3 and 6 months between ALS patients and their healthy controls [ Time Frame: 6 month ]
    Comparison of changes in retinal layer thickness parameters over 3 and 6 months between ALS patients and their healthy controls in micrometers

  2. Correlation between changes in retinal layers thickness and ALS-FRS scores in patients with ALS [ Time Frame: 6 month ]
    Correlation between changes in retinal layers thickness in micrometers and ALS-FRS scores in ALS patients over 3 and 6 month

  3. Correlation between changes in retinal layers thickness and Pulmonary function test parameters in ALS patients over 3 and 6 months [ Time Frame: 6 month ]
    Correlation between changes in retinal layers thickness parameters in micrometers and changes in FEV1 in liters and FVC in liters on pulmonary function testing in patients with ALS over 3 and 6 month



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of ALS according to the El Escorial criteria.
  • Age 18 years to 80 years old
  • Disease duration less than 36 months
  • Patients logistically able to attend and be evaluated at baseline, 3 and 6 months

Exclusion Criteria:

  • Patients with diabetes mellitus
  • Patients with glaucoma, refractive errors of ± 6 diopters or more, or other ophthalmologic disorders such as media opacities that could interfere with retinal OCT assessment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377868


Contacts
Contact: Achraf Makki, MD +9611350000 ext 7359 am132@aub.edu.lb
Contact: Elia Malek, MD em26@aub.edu.lb

Sponsors and Collaborators
American University of Beirut Medical Center

Publications:

Responsible Party: Achraf Makki, Assistant professor, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT03377868     History of Changes
Other Study ID Numbers: IM.AS.01
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017

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

Additional relevant MeSH terms:
Sclerosis
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases