Amyotrophic Lateral SclerosisNCT03377868
Optic Coherence Tomography in Patients With Amyotrophic Lateral Sclerosis
A study testing Optic coherence tomography and Pulmonary function test in people with Amyotrophic Lateral Sclerosis, run by American University of Beirut Medical Center.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Optic coherence tomography and Pulmonary function test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 3 Jan 2018to 28 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Elia Malek, MD contact
About this study
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
- Being tested
- Optic coherence tomography, Pulmonary function test
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optic coherence tomographyDiagnostic test
Optic coherence tomography measures retinal layer thickness, macular volume , and cell inner plexiform layer.
Pulmonary function testDiagnostic test
Pulmonary function test measures forced vital capacity and forced expiratory volume in one second.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Amyotrophic lateral sclerosis | Other | Patients diagnosed with amyotrophic lateral sclerosis Receives: Diagnostic Test: Optic coherence tomography; Diagnostic Test: Pulmonary function test |
| Control | Other | Parallel cohort of healthy age and sex matched subjects Receives: Diagnostic Test: Optic coherence tomography; Diagnostic Test: Pulmonary function test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Comparison of changes in retinal layer thickness parameters over 3 and 6 months between ALS patients and their healthy controls in micrometers
Measured: 6 month
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
Measured: 6 month
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
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start3 Jan 2018 (estimated)
- Primary completion28 Jul 2018 (estimated)
- Study completion28 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Achraf Makki, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377868
- Sponsor's protocol ID
- IM.AS.01
- Status last verified
- Dec 2017
- First submitted
- 6 Dec 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25157374Grosskreutz 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.
PubMed 16638121Hammad 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.
PubMed 18071143Radtke RA, Erwin A, Erwin CW. Abnormal sensory evoked potentials in amyotrophic lateral sclerosis. Neurology. 1986 Jun;36(6):796-801. doi: 10.1212/wnl.36.6.796.
PubMed 3703285Munte 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.
PubMed 9591221Moss 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.
PubMed 22192877Huang 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.
PubMed 1957169Puliafito 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.
PubMed 7862410Jimenez 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.
PubMed 24458320Ascaso 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.
PubMed 24846203Bertuzzi 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.
PubMed 20381872Bennett 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.
PubMed 25662342Roth 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.
PubMed 23582075Ringelstein 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.
PubMed 25590041Simonett 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.
PubMed 27383525
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optic Coherence Tomography in Patients With Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT03377868
- Acronym / sponsor ID
- IM.AS.01
- Conditions
- Amyotrophic Lateral Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 3 Jan 2018 (estimated)
- Primary completion
- 28 Jul 2018 (estimated)
- Study completion
- 28 Sep 2018 (estimated)
- First posted
- 19 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Patients with Amyotrophic lateral sclerosis | Other | Diagnostic Test: Optic coherence tomography, Diagnostic Test: Pulmonary function testPatients diagnosed with amyotrophic lateral sclerosis |
| Control | Other | Diagnostic Test: Optic coherence tomography, Diagnostic Test: Pulmonary function testParallel cohort of healthy age and sex matched subjects |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optic coherence tomographyOptic coherence tomography measures retinal layer thickness, macular volume , and cell inner plexiform layer. | Diagnostic test | Control, Patients with Amyotrophic lateral sclerosis |
| Pulmonary function testPulmonary function test measures forced vital capacity and forced expiratory volume in one second. | Diagnostic test | Control, Patients with Amyotrophic lateral sclerosis |
Primary outcome
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
3 secondary outcomes
Comparison of changes in retinal layer thickness parameters over 3 and 6 months between ALS patients and their healthy controls
Time frame: 6 month
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 and Pulmonary function test parameters in ALS patients over 3 and 6 months
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
- Background: PubMed 25157374Calvo 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.
- Background: PubMed 16638121Grosskreutz 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.
- Background: PubMed 18071143Hammad 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.
- Background: PubMed 3703285Radtke RA, Erwin A, Erwin CW. Abnormal sensory evoked potentials in amyotrophic lateral sclerosis. Neurology. 1986 Jun;36(6):796-801. doi: 10.1212/wnl.36.6.796.
- Background: PubMed 9591221Munte 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.
- Background: PubMed 22192877Moss 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.
- Background: PubMed 1957169Huang 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.
- Background: PubMed 7862410Puliafito 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.
- Background: PubMed 24458320Jimenez 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.
- Background: PubMed 24846203Ascaso 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.
- Background: PubMed 20381872Bertuzzi 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.
- Background: PubMed 25662342Bennett 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elia Malek, MD contact
Questions about this trial
What is this clinical trial studying?
A study testing Optic coherence tomography and Pulmonary function test in people with Amyotrophic Lateral Sclerosis, run by American University of Beirut Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Achraf Makki, MD (+9611350000 ext. 7359, am132@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in retinal layer thickness parameters over 3 and 6 months in ALS patients (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03377868, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2017.