Optic Coherence Tomography in Patients With Amyotrophic Lateral Sclerosis

NCT03377868 | Unknown DMC

• 1 other identifier: IM.AS.01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• Change in retinal layer thickness parameters over 3 and 6 months in ALS patients

  Observing the change in retinal layers thickness parameters in micrometers in ALS patients from baseline to 3 and 6 months

  6 months

Secondary Outcomes (3)

• Comparison of changes in retinal layer thickness parameters over 3 and 6 months between ALS patients and their healthy controls

  6 month

• Correlation between changes in retinal layers thickness and ALS-FRS scores in patients with ALS

  6 month

• Correlation between changes in retinal layers thickness and Pulmonary function test parameters in ALS patients over 3 and 6 months

  6 month

Study Arms (2)

Patients with Amyotrophic lateral sclerosis

OTHER

Patients diagnosed with amyotrophic lateral sclerosis

Diagnostic Test: Optic coherence tomography; Diagnostic Test: Pulmonary function test

Control

OTHER

Parallel cohort of healthy age and sex matched subjects

Diagnostic Test: Optic coherence tomography; Diagnostic Test: Pulmonary function test

Interventions

Optic coherence tomography DIAGNOSTIC_TEST

Optic coherence tomography measures retinal layer thickness, macular volume , and cell inner plexiform layer.

Control; Patients with Amyotrophic lateral sclerosis

Pulmonary function test DIAGNOSTIC_TEST

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

Control; Patients with Amyotrophic lateral sclerosis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Related Publications (16)

• Calvo AC, Manzano R, Mendonca DM, Munoz MJ, Zaragoza P, Osta R. Amyotrophic lateral sclerosis: a focus on disease progression. Biomed Res Int. 2014;2014:925101. doi: 10.1155/2014/925101. Epub 2014 Aug 3.

  PMID: 25157374 BACKGROUND

• Grosskreutz J, Kaufmann J, Fradrich J, Dengler R, Heinze HJ, Peschel T. Widespread sensorimotor and frontal cortical atrophy in Amyotrophic Lateral Sclerosis. BMC Neurol. 2006 Apr 25;6:17. doi: 10.1186/1471-2377-6-17.

  PMID: 16638121 BACKGROUND

• Hammad M, Silva A, Glass J, Sladky JT, Benatar M. Clinical, electrophysiologic, and pathologic evidence for sensory abnormalities in ALS. Neurology. 2007 Dec 11;69(24):2236-42. doi: 10.1212/01.wnl.0000286948.99150.16.

  PMID: 18071143 BACKGROUND

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  PMID: 3703285 BACKGROUND

• Munte TF, Troger MC, Nusser I, Wieringa BM, Johannes S, Matzke M, Dengler R. Alteration of early components of the visual evoked potential in amyotrophic lateral sclerosis. J Neurol. 1998 Apr;245(4):206-10. doi: 10.1007/s004150050206.

  PMID: 9591221 BACKGROUND

• Moss HE, McCluskey L, Elman L, Hoskins K, Talman L, Grossman M, Balcer LJ, Galetta SL, Liu GT. Cross-sectional evaluation of clinical neuro-ophthalmic abnormalities in an amyotrophic lateral sclerosis population. J Neurol Sci. 2012 Mar 15;314(1-2):97-101. doi: 10.1016/j.jns.2011.10.016. Epub 2011 Dec 21.

  PMID: 22192877 BACKGROUND

• Huang D, Swanson EA, Lin CP, Schuman JS, Stinson WG, Chang W, Hee MR, Flotte T, Gregory K, Puliafito CA, et al. Optical coherence tomography. Science. 1991 Nov 22;254(5035):1178-81. doi: 10.1126/science.1957169.

  PMID: 1957169 BACKGROUND

• Puliafito CA, Hee MR, Lin CP, Reichel E, Schuman JS, Duker JS, Izatt JA, Swanson EA, Fujimoto JG. Imaging of macular diseases with optical coherence tomography. Ophthalmology. 1995 Feb;102(2):217-29. doi: 10.1016/s0161-6420(95)31032-9.

  PMID: 7862410 BACKGROUND

• Jimenez B, Ascaso FJ, Cristobal JA, Lopez del Val J. Development of a prediction formula of Parkinson disease severity by optical coherence tomography. Mov Disord. 2014 Jan;29(1):68-74. doi: 10.1002/mds.25747. Epub 2013 Nov 14.

  PMID: 24458320 BACKGROUND

• Ascaso FJ, Cruz N, Modrego PJ, Lopez-Anton R, Santabarbara J, Pascual LF, Lobo A, Cristobal JA. Retinal alterations in mild cognitive impairment and Alzheimer's disease: an optical coherence tomography study. J Neurol. 2014 Aug;261(8):1522-30. doi: 10.1007/s00415-014-7374-z. Epub 2014 May 21.

  PMID: 24846203 BACKGROUND

• Bertuzzi F, Suzani M, Tagliabue E, Cavaletti G, Angeli R, Balgera R, Rulli E, Ferrarese C, Miglior S. Diagnostic validity of optic disc and retinal nerve fiber layer evaluations in detecting structural changes after optic neuritis. Ophthalmology. 2010 Jun;117(6):1256-1264.e1. doi: 10.1016/j.ophtha.2010.02.024. Epub 2010 Apr 9.

  PMID: 20381872 BACKGROUND

• Bennett JL, de Seze J, Lana-Peixoto M, Palace J, Waldman A, Schippling S, Tenembaum S, Banwell B, Greenberg B, Levy M, Fujihara K, Chan KH, Kim HJ, Asgari N, Sato DK, Saiz A, Wuerfel J, Zimmermann H, Green A, Villoslada P, Paul F; GJCF-ICC&BR. Neuromyelitis optica and multiple sclerosis: Seeing differences through optical coherence tomography. Mult Scler. 2015 May;21(6):678-88. doi: 10.1177/1352458514567216. Epub 2015 Feb 6.

  PMID: 25662342 BACKGROUND

• Roth NM, Saidha S, Zimmermann H, Brandt AU, Oberwahrenbrock T, Maragakis NJ, Tumani H, Ludolph AC, Meyer T, Calabresi PA, Paul F. Optical coherence tomography does not support optic nerve involvement in amyotrophic lateral sclerosis. Eur J Neurol. 2013 Aug;20(8):1170-6. doi: 10.1111/ene.12146. Epub 2013 Apr 14.

  PMID: 23582075 BACKGROUND

• Ringelstein M, Albrecht P, Sudmeyer M, Harmel J, Muller AK, Keser N, Finis D, Ferrea S, Guthoff R, Schnitzler A, Hartung HP, Methner A, Aktas O. Subtle retinal pathology in amyotrophic lateral sclerosis. Ann Clin Transl Neurol. 2014 Apr;1(4):290-7. doi: 10.1002/acn3.46. Epub 2014 Mar 11.

  PMID: 25590041 BACKGROUND

• Simonett JM, Huang R, Siddique N, Farsiu S, Siddique T, Volpe NJ, Fawzi AA. Macular sub-layer thinning and association with pulmonary function tests in Amyotrophic Lateral Sclerosis. Sci Rep. 2016 Jul 7;6:29187. doi: 10.1038/srep29187.

  PMID: 27383525 BACKGROUND

• Saidha S, Al-Louzi O, Ratchford JN, Bhargava P, Oh J, Newsome SD, Prince JL, Pham D, Roy S, van Zijl P, Balcer LJ, Frohman EM, Reich DS, Crainiceanu C, Calabresi PA. Optical coherence tomography reflects brain atrophy in multiple sclerosis: A four-year study. Ann Neurol. 2015 Nov;78(5):801-13. doi: 10.1002/ana.24487. Epub 2015 Oct 1.

  PMID: 26190464 BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Respiratory Function Tests

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Achraf Makki, MD

CONTACT

+9611350000; am132@aub.edu.lb

Elia Malek, MD

CONTACT

em26@aub.edu.lb

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Observational study of a cohort of patients with amyotrophic lateral sclerosis compared to a parallel cohort of healthy age and sex matched subjects

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 19, 2017
• Study Start: January 3, 2018
• Primary Completion: July 28, 2018
• Study Completion: September 28, 2018
• Last Updated: December 19, 2017

Record last verified: 2017-12