Optic Coherence Tomography in Patients With Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Optic Coherence Tomography in Patients With Amyotrophic Lateral Sclerosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03377868
• Other study ID #: IM.AS.01
• Status: Not yet recruiting
• Phase: N/A
• First received: December 6, 2017
• Last updated: December 16, 2017
• Start date: January 3, 2018
• Est. completion date: September 28, 2018

Study information

• Verified date: December 2017
• Source: American University of Beirut Medical Center
• Contact: Achraf Makki, MD
• Phone: +9611350000
• Email: am132[@]aub.edu.lb
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 28, 2018
• Est. primary completion date: July 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Diagnostic Test:
• Optic coherence tomography
Optic coherence tomography measures retinal layer thickness, macular volume , and cell inner plexiform layer.
• Pulmonary function test
Pulmonary function test measures forced vital capacity and forced expiratory volume in one second.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

References & Publications (16)

Ascaso FJ, Cruz N, Modrego PJ, Lopez-Anton R, Santabárbara J, Pascual LF, Lobo A, Cristóbal 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. — View Citation

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. Review. — View Citation

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. — View Citation

Calvo AC, Manzano R, Mendonça DM, Muñoz 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. Review. — View Citation

Grosskreutz J, Kaufmann J, Frädrich J, Dengler R, Heinze HJ, Peschel T. Widespread sensorimotor and frontal cortical atrophy in Amyotrophic Lateral Sclerosis. BMC Neurol. 2006 Apr 25;6:17. — View Citation

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. — View Citation

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. — View Citation

Jiménez B, Ascaso FJ, Cristóbal JA, López 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. — View Citation

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. — View Citation

Münte TF, Tröger 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. — View Citation

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. — View Citation

Radtke RA, Erwin A, Erwin CW. Abnormal sensory evoked potentials in amyotrophic lateral sclerosis. Neurology. 1986 Jun;36(6):796-801. — View Citation

Ringelstein M, Albrecht P, Südmeyer M, Harmel J, Müller 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison of changes in retinal layer thickness parameters over 3 and 6 months between ALS patients and their healthy controls	Comparison of changes in retinal layer thickness parameters over 3 and 6 months between ALS patients and their healthy controls in micrometers	6 month
Secondary	Correlation between changes in retinal layers thickness and ALS-FRS scores in patients with ALS	Correlation between changes in retinal layers thickness in micrometers and ALS-FRS scores in ALS patients over 3 and 6 month	6 month
Secondary	Correlation between changes in retinal layers thickness and Pulmonary function test parameters in ALS patients over 3 and 6 months	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	6 month