Amyotrophic Lateral SclerosisNCT03285204
Relationship Between Neurological Disability and Visual Impairment in Patients With ALS or Friedreich's Ataxia
An observational study of Amyotrophic Lateral Sclerosis, run by Jose Luis Urcelay Segura at 1 site in Spain.
Trial summary
The aim of this study is to obtain an early biomarker of amyotrophic lateral sclerosis and Friedreich's Ataxia which allows to diagnose the disease in an initial stage and to follow up the patient with optic coherence tomography, a fast, non-invasive and comfortable method Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2015to Feb 2020
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Amyotrophic lateral sclerosis patients Friedreich's ataxia patients Healthy volunteers
Who may be able to join
- Older than 18 years.
- Best corrected visual acuity more than 0.4 (20/50 Snellen = 0.4 logMAR = 65 ETDRS letters).
- Refractive defect less than 5 diopters of spherical equivalent and / or cylinder less than 2 diopters.
- Transparent optical media: Opacity of crystalline <1 according to Lens Opacities Classification System (LOCS) III.
- Open anterior chamber angle assessed by gonioscopy with Goldmann lens (grade> III).
- Availability and collaboration to carry out the tests of the exploratory protocol.
- Acceptance of informed consent.
Who cannot join
- Previous intraocular surgeries of less than 6 months of evolution. Patients with refractive surgery using the LASIK or LASEK technique will not be excluded.
- Physical or mental difficulties to perform reliable and reproducible perimeters.
- Pathology and / or ocular malformations, angular or optic nerve anomalies.
- Any retinopathy or maculopathy.
- Intraocular pressure (IOP)> 21 mmHg.
- Signal-to-noise ratio in OCT less than 5/10.
- Failure to meet any inclusion criteria.
- Mental retardation or any other limitation in obtaining informed consent.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Pilar Rojas Lozano
Madrid, 28010
Pilar Rojas Lozano, +34616042758, pilar.rojas.lozano@gmail.com
About this study
The aim of this study is to obtain an early biomarker of amyotrophic lateral sclerosis and Friedreich's Ataxia which allows to diagnose the disease in an initial stage and to follow up the patient with optic coherence tomography, a fast, non-invasive and comfortable method
Read the detailed description
All patients will be asked about their data and their general medical history, and will be underwent on one hand, a complete neurological examination including the degree of neurological impairment quantified according to the functional rating scale of ALS (ALSFRS-r) or Scale for the assessment and rating of ataxia (SARA); On the other hand, they will have a complete ophthalmological examination too, including the patient's graduation, pupillary and ocular motility examination, biomicroscopy, Goldman tonometry and fundus exam. Patients will be performed too a conventional automated Humprey perimetry, color test (Farnsworth-Munsell 28 Hue Color Vision Test) and finally an optical coherence tomography (OCT) in order to see possible anatomical alterations in both macula and optic nerve. The follow-up of these explorations will be repeated in all cases at 6 months.
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- optical coherence tomography, amyotrophic lateral sclerosis
- 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.
| Study group | Role | What they receive |
|---|---|---|
| ALS patients | Not described | |
| Friedreich Ataxia patients | Not described | |
| Healthy control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
early biomarker of amyotrophic lateral sclerosis and Friedreich's Ataxia
macular, ganglion cell layer and retinal nerve fiber layer thickness measure
Measured: change from baseline to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study startJul 2015
- Primary completionJan 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jose Luis Urcelay Segura
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jose Luis Urcelay Segura, Hospital General Universitario Gregorio Marañon
- Investigators
- Jose L Urcelay, PhD, Principal investigator, HGU Gregorio Marañón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285204
- Sponsor's protocol ID
- ELA-AF-OCT-2014-01
- Status last verified
- Apr 2018
- First submitted
- 8 Mar 2017
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Neurological Disability and Visual Impairment in Patients With ALS or Friedreich's Ataxia
- ClinicalTrials.gov ID
- NCT03285204
- Acronym / sponsor ID
- ELA-AF-OCT-2014-01
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- optical coherence tomography, amyotrophic lateral sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Jose Luis Urcelay SeguraUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 15 Sep 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.
The aim of this study is to obtain an early biomarker of amyotrophic lateral sclerosis and Friedreich's Ataxia which allows to diagnose the disease in an initial stage and to follow up the patient with optic coherence tomography, a fast, non-invasive and comfortable method
Detailed description
All patients will be asked about their data and their general medical history, and will be underwent on one hand, a complete neurological examination including the degree of neurological impairment quantified according to the functional rating scale of ALS (ALSFRS-r) or Scale for the assessment and rating of ataxia (SARA); On the other hand, they will have a complete ophthalmological examination too, including the patient's graduation, pupillary and ocular motility examination, biomicroscopy, Goldman tonometry and fundus exam. Patients will be performed too a conventional automated Humprey perimetry, color test (Farnsworth-Munsell 28 Hue Color Vision Test) and finally an optical coherence tomography (OCT) in order to see possible anatomical alterations in both macula and optic nerve. The follow-up of these explorations will be repeated in all cases at 6 months.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ALS patients | – | – |
| Friedreich Ataxia patients | – | – |
| Healthy control | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Amyotrophic lateral sclerosis patients Friedreich's ataxia patients Healthy volunteers
Key inclusion criteria (7 listed)
- Older than 18 years.
- Best corrected visual acuity more than 0.4 (20/50 Snellen = 0.4 logMAR = 65 ETDRS letters).
- Refractive defect less than 5 diopters of spherical equivalent and / or cylinder less than 2 diopters.
- Transparent optical media: Opacity of crystalline <1 according to Lens Opacities Classification System (LOCS) III.
- Open anterior chamber angle assessed by gonioscopy with Goldmann lens (grade> III).
Key exclusion criteria (8 listed)
- Previous intraocular surgeries of less than 6 months of evolution. Patients with refractive surgery using the LASIK or LASEK technique will not be excluded.
- Physical or mental difficulties to perform reliable and reproducible perimeters.
- Pathology and / or ocular malformations, angular or optic nerve anomalies.
- Any retinopathy or maculopathy.
- Intraocular pressure (IOP)> 21 mmHg.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
early biomarker of amyotrophic lateral sclerosis and Friedreich's Ataxia
Time frame: change from baseline to 6 month
macular, ganglion cell layer and retinal nerve fiber layer thickness measure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Jose L Urcelay, PhD principal investigator
HGU Gregorio Marañón
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis, run by Jose Luis Urcelay Segura at 1 site in Spain.
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 7 inclusion and 8 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 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Pilar Rojas, MD (+34616042758, pilar.rojas.lozano@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early biomarker of amyotrophic lateral sclerosis and Friedreich's Ataxia (time frame: change from baseline to 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2019.