Injury BrainNCT04937725
Reading Problems Associated With Central Nervous System (CNS) Pathologies.
An observational study of Injury Brain and Eye Abnormalities, run by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA at 1 site in Spain.
Trial summary
This project aims to analyse eye movements, their alterations and influence in reading performance in patients with acquired CNS diseases and compare them with people of the same age, without neurological or ocular pathology and with normal reading speed and pattern. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Injury Brain, Eye Abnormalities, Multiple Sclerosis
- What is being tested?
- eye tracking
- How many people
- 75 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2021to 30 Nov 2022
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal population (no pathology) and people with neurological pathologies such as multiple sclerosis, Parkinson, tumours, or stroke, cerebellum ataxia and other miscellaneous neurological disorders.
Who may be able to join
- Patients and normal volunteers with ages between 18 and 80 years old.
- Clinical radiological neurological stability in acute CNS diseases (≥ 3 months after ACD).
- Best distant binocular visual acuity, equal or greater than 0.5 (Decimal Scale). Best close binocular visual acuity, equal or greater than 20/40.Glasses or soft contact lenses users.
Who cannot join
- Presence of visual heminegligence evaluated with clock drawing test and line bisection test.
- Presence of visual agnosia: Poppelreuter-Ghent © test.
- Presence of cognitive deficit: mini mental state examination (MMSE), with sufficient residual hearing capacity.
- Medical history, or presence after ophthalmic examination of: maculopathy, advanced cataracts, ophthalmological diseases affecting central visual acuity or macular fixation.
- Healthy control subjects should have normal monocular perimetry using standard Swedish interactive threshold algorithm (SITA) Central 30-2 Humphrey® Perimeter Test .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reading Problems Associated With Central Nervous System Pathologies
This project aims to analyse eye movements, their alterations and influence in reading performance in patients with acquired CNS diseases and compare them with people of the same age, without neurological or ocular pathology and with normal reading speed and pattern.
The exploration is focused on the oculomotor system in patients with CNS diseases, even without involvement of the primary visual pathway, and reveals more involvement than the one obtained by a simple ophthalmological examination.
Read the detailed description
The following protocol will be applied:
Neuropsychological function Clock Test- Clock Drawing, whose score corresponds to a scale of 1 to 6, from perfect organization to severe disorder respectively, with a cognitive deficit being a result greater than 3. This test is used to detect signs of heminegligence in addition to the Line Bisection Test. It will consider the displacement of the central mark to the right side as a positive sign.
Mini-Cognitive Exam, whose cut-off score corresponds to 23 out of the 30 total, equal to or less than this figure, would indicate the presence of a cognitive deficit.
Far and near Best corrected visual acuity Primary gaze position Cover test (far and near) Extrinsic ocular motility Nystagmus presence Intrinsic ocular motility Biomicroscopy of the anterior pole Computerized visual field 30-2 Intraocular pressure Ocular fundus examination Records with Tobii Pro Nano Hardware Package eye-tracking system and Tobii Pro Lab - Full Edition software.
Reading performance assessment: International Reading Speed Texts (IReST) Attentional questionnaire based on the IReST, two simple answer questions (one word) will be formulated for each text, at the end of the reading to check the reading comprehension of the patient Evaluation of the speed and quality of horizontal and vertical reading: Test DEM (Developmental Eye Movement).
Eye-tracking test: with an animation of a moving circle.
- Conditions
- Injury Brain, Eye Abnormalities, Multiple Sclerosis, Parkinson Disease, Ataxia, Cerebellar
- Being tested
- eye tracking
- Keywords
- eye tracking
- Medical subject headings
- Brain Injuries, Eye Abnormalities, Multiple Sclerosis, Parkinson Disease, Cerebellar Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eye trackingDiagnostic test
Eye tracker will be used to evaluate study parameters
| Study group | Role | What they receive |
|---|---|---|
| Patients without neurological pathologies | Patients with no history of neurological diseases Receives: Diagnostic Test: eye tracking | |
| Patients with neurological pathologies | Not described Receives: Diagnostic Test: eye tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reading performance
International Reading Speed Texts (IReST)
Measured: 24 Hours
Secondary outcomes (1)
Reading performance
DEM (Developmental Eye Movement).ocular (DEM)
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start1 Jun 2021
- Primary completion1 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury BrainStudies 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clínico Universitario de Valladolid, Hospital del Rio Hortega
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937725
- Sponsor's protocol ID
- PI21-2247 TFM
- Status last verified
- Jan 2023
- First submitted
- 16 Jun 2021
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reading Problems Associated With Central Nervous System Pathologies
- ClinicalTrials.gov ID
- NCT04937725
- Acronym / sponsor ID
- PI21-2247 TFM
- Conditions
- Injury Brain, Eye Abnormalities, Multiple Sclerosis, Parkinson Disease, Ataxia, Cerebellar
- Keywords
- eye tracking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBAUniversity, hospital or other
- Collaborators
- Hospital Clínico Universitario de Valladolid, Hospital del Rio Hortega
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 24 Jun 2021 (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.
This project aims to analyse eye movements, their alterations and influence in reading performance in patients with acquired CNS diseases and compare them with people of the same age, without neurological or ocular pathology and with normal reading speed and pattern.
The exploration is focused on the oculomotor system in patients with CNS diseases, even without involvement of the primary visual pathway, and reveals more involvement than the one obtained by a simple ophthalmological examination.
Detailed description
The following protocol will be applied:
Neuropsychological function Clock Test- Clock Drawing, whose score corresponds to a scale of 1 to 6, from perfect organization to severe disorder respectively, with a cognitive deficit being a result greater than 3. This test is used to detect signs of heminegligence in addition to the Line Bisection Test. It will consider the displacement of the central mark to the right side as a positive sign.
Mini-Cognitive Exam, whose cut-off score corresponds to 23 out of the 30 total, equal to or less than this figure, would indicate the presence of a cognitive deficit.
Far and near Best corrected visual acuity Primary gaze position Cover test (far and near) Extrinsic ocular motility Nystagmus presence Intrinsic ocular motility Biomicroscopy of the anterior pole Computerized visual field 30-2 Intraocular pressure Ocular fundus examination Records with Tobii Pro Nano Hardware Package eye-tracking system and Tobii Pro Lab - Full Edition software.
Reading performance assessment: International Reading Speed Texts (IReST) Attentional questionnaire based on the IReST, two simple answer questions (one word) will be formulated for each text, at the end of the reading to check the reading comprehension of the patient Evaluation of the speed and quality of horizontal and vertical reading: Test DEM (Developmental Eye Movement).
Eye-tracking test: with an animation of a moving circle.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without neurological pathologies | – | Diagnostic Test: eye trackingPatients with no history of neurological diseases |
| Patients with neurological pathologies | – | Diagnostic Test: eye tracking |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal population (no pathology) and people with neurological pathologies such as multiple sclerosis, Parkinson, tumours, or stroke, cerebellum ataxia and other miscellaneous neurological disorders.
Key inclusion criteria (3 listed)
- Patients and normal volunteers with ages between 18 and 80 years old.
- Clinical radiological neurological stability in acute CNS diseases (≥ 3 months after ACD).
- Best distant binocular visual acuity, equal or greater than 0.5 (Decimal Scale). Best close binocular visual acuity, equal or greater than 20/40.Glasses or soft contact lenses users.
Key exclusion criteria (5 listed)
- Presence of visual heminegligence evaluated with clock drawing test and line bisection test.
- Presence of visual agnosia: Poppelreuter-Ghent © test.
- Presence of cognitive deficit: mini mental state examination (MMSE), with sufficient residual hearing capacity.
- Medical history, or presence after ophthalmic examination of: maculopathy, advanced cataracts, ophthalmological diseases affecting central visual acuity or macular fixation.
- Healthy control subjects should have normal monocular perimetry using standard Swedish interactive threshold algorithm (SITA) Central 30-2 Humphrey® Perimeter Test .
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 |
|---|---|---|
| eye trackingEye tracker will be used to evaluate study parameters | Diagnostic test | Patients with neurological pathologies, Patients without neurological pathologies |
Primary outcome
Reading performance
Time frame: 24 Hours
International Reading Speed Texts (IReST)
1 secondary outcome
Reading performance
Time frame: 24 Hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Injury Brain and Eye Abnormalities, run by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 2 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reading performance (time frame: 24 Hours). 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 2 Feb 2023.