Visual NeurosciencesNCT05675852
Evaluation of Visual Parameters by Visual Evoked Potentials Captured by EEG
An observational study of Visual Neurosciences, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
This project will be based on an approach that has already proven itself in the field of the development of low-level visual functions such as visual acuity, vernier acuity and contrast sensitivity (Norcia \& Tyler, 1985): scanning visual evoked potentials" (sVEP), a special case of steady-state visual evoked… Read more about this study
- Who is it for?
- Ages 1 year to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Neurosciences
- What is being tested?
- 68-electrode electroencephalography with steady state visual evoked potentials
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2022to Apr 2023
- 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 1 year to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy participants to better understand visual neurosciences.
Who may be able to join
- Absence of ocular pathologies except for refractive errors
- Absence of neurologic conditions
Who cannot join
- Participants using neurologic or psychiatric drugs
- Scalp pathology
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Institute Of NeuroSciences
Woluwe-Saint-Lambert, Brussels Capital, 1200
Coralie Hemptinne, MD, PhD, +32 (2) 764 1968, coralie.hemptinne@saintluc.uclouvain.be
Nathan Hupin, MD, +32 495191707, nathan.hupin@student.uclouvain.be
About this study
Official title: Evaluation of Visual Parameters in Healthy and Visually Impaired Adults Using the Sweep and Oddball Technique Associated With Visual Evoked Potentials Captured by EEG
This project will be based on an approach that has already proven itself in the field of the development of low-level visual functions such as visual acuity, vernier acuity and contrast sensitivity (Norcia \& Tyler, 1985): scanning visual evoked potentials" (sVEP), a special case of steady-state visual evoked potentials (SSVEP). While SSVEPs consist of presenting a visual stimulus periodically, sVEPs are SSVEPs where the value of a parameter (e.g. the contrast of the stimulus) varies. This variation ("scanning") makes it possible to determine the threshold value where an electroencephalographic (EEG) response is perceived, and thus to evaluate visual parameters such as visual acuity, vernier acuity and contrast sensitivity. In this study we therefore record the amplitude of the EEG electrical signal during the presentation of low-level stimuli such as spatial frequency gratings or increasing or decreasing contrast.
- Conditions
- Visual Neurosciences
- Being tested
- 68-electrode electroencephalography with steady state visual evoked potentials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68-electrode electroencephalography with steady state visual evoked potentialsOther
Electroencephalography is registered through a 68-electrode electroencephalography while stimuli will be presented at the centre of the screen at a distance of 150cm.
The pattern of visual stimulation is based on the technique of steady state visual evoked potentials. These potentials consist of the presentation of a visual stimulus at a (relatively fast) periodic rate to produce an EEG signal over the occipital cortex exactly at the frequency of stimulation. By varying the value of a parameter of the stimulation (e.g. the contrast of the stimulus) varies. This variation makes it possible to determine the threshold value where an EEG response is perceived, and thus to evaluate visual parameters such as visual acuity, contrast sensitivity or recognition of more complex shapes.
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | Healthy participants aged from 1 to 75 years old. All experiments conducted in this study will make use of the electroencephalogram (EEG) recording technique. Healthy participants cannot participate if they suffer from dermatosis on the scalp. There is no other contraindication to the practice of an EEG, which simply consists of recording the electrical activity of the brain on a trace, after application of a conductive gel on the scalp where sensors connected to a recording device are placed.
We will collect the cerebral electrical response by the technique of steady state visual evoked potentials (SSVEP) which consists of presenting a visual stimulus periodically to interpret the EEG signal according to those variations. Receives: Other: 68-electrode electroencephalography with steady state visual evoked potentials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Threshold of visual recognition of low and high grade visual stimuli
Fast periodic visual stimulation using stimuli such as gratings, checkerboards, words and faces
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start1 Dec 2022
- Primary completionJan 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual NeurosciencesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675852
- Sponsor's protocol ID
- 2017%244
- Status last verified
- Jan 2023
- First submitted
- 3 Jan 2023
- Last updated
- 9 Jan 2023
- Results posted
- 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 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Visual Parameters in Healthy and Visually Impaired Adults Using the Sweep and Oddball Technique Associated With Visual Evoked Potentials Captured by EEG
- ClinicalTrials.gov ID
- NCT05675852
- Acronym / sponsor ID
- 2017%244
- Conditions
- Visual Neurosciences
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 9 Jan 2023 (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 will be based on an approach that has already proven itself in the field of the development of low-level visual functions such as visual acuity, vernier acuity and contrast sensitivity (Norcia \& Tyler, 1985): scanning visual evoked potentials" (sVEP), a special case of steady-state visual evoked potentials (SSVEP). While SSVEPs consist of presenting a visual stimulus periodically, sVEPs are SSVEPs where the value of a parameter (e.g. the contrast of the stimulus) varies. This variation ("scanning") makes it possible to determine the threshold value where an electroencephalographic (EEG) response is perceived, and thus to evaluate visual parameters such as visual acuity, vernier acuity and contrast sensitivity. In this study we therefore record the amplitude of the EEG electrical signal during the presentation of low-level stimuli such as spatial frequency gratings or increasing or decreasing contrast.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | – | Other: 68-electrode electroencephalography with steady state visual evoked potentialsHealthy participants aged from 1 to 75 years old. All experiments conducted in this study will make use of the electroencephalogram (EEG) recording technique. Healthy participants cannot participate if they suffer from dermatosis on the scalp. There is no other contraindication to the practice of an EEG, which simply consists of recording the electrical activity of the brain on a trace, after application of a conductive gel on the scalp where sensors connected to a recording device are placed. We will collect the cerebral electrical response by the technique of steady state visual evoked potentials (SSVEP) which consists of presenting a visual stimulus periodically to interpret the EEG signal according to those variations. |
Who may qualify
- Ages
- 1 year to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy participants to better understand visual neurosciences.
Key inclusion criteria (2 listed)
- Absence of ocular pathologies except for refractive errors
- Absence of neurologic conditions
Key exclusion criteria (2 listed)
- Participants using neurologic or psychiatric drugs
- Scalp pathology
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 |
|---|---|---|
| 68-electrode electroencephalography with steady state visual evoked potentialsElectroencephalography is registered through a 68-electrode electroencephalography while stimuli will be presented at the centre of the screen at a distance of 150cm. The pattern of visual stimulation is based on the technique of steady state visual evoked potentials. These potentials consist of the presentation of a visual stimulus at a (relatively fast) periodic rate to produce an EEG signal over the occipital cortex exactly at the frequency of stimulation. By varying the value of a parameter of the stimulation (e.g. the contrast of the stimulus) varies. This variation makes it possible to determine the threshold value where an EEG response is perceived, and thus to evaluate visual parameters such as visual acuity, contrast sensitivity or recognition of more complex shapes. | Other | Healthy participants |
Primary outcome
Threshold of visual recognition of low and high grade visual stimuli
Time frame: 4 months
Fast periodic visual stimulation using stimuli such as gratings, checkerboards, words and faces
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- 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.
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 Visual Neurosciences, run by Université Catholique de Louvain at 1 site in Belgium.
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 2 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 9 Jan 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 Belgium. 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 Demet Yuksel (+32 (2) 764 21 48, demet.yuksel@saintluc.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Threshold of visual recognition of low and high grade visual stimuli (time frame: 4 months). 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 9 Jan 2023.