Neurologic SignsHIERARCHYNCT03905616
HIERARCHY OF VISION
A study testing functional Magnetic Resonance Imaging in people with Neurologic Signs, run by Hospices Civils de Lyon.
Trial summary
Little is known about the exact role of feedback in cortical processing. Hypotheses on its function range from attentional control to the transmission of Bayesian priors in the interpretation of sensory events, such as in the theory of Predictive Coding. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurologic Signs
- What is being tested?
- functional Magnetic Resonance Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 22 Jul 2019to 17 Feb 2021
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18 and 40 years old
- Affiliated to a social security scheme
- Be right-handed
- Have signed the informed consent
Who cannot join
- Subjects with a neurological or psychiatric history
- Subjects with visual disturbances not corrected
- Pregnant, lactating or childbearing women without contraception.
- Persons under guardianship, trusteeship or any other administrative or judicial measure of deprivation of rights or liberty, as well as adults protected by law.
- Participants refusing to be informed of the results of the medical examination.
- Participants refusing to be informed of the possible detection of an anomaly.
- Volunteers with contraindications to the MRI examination: people using a pacemaker or an insulin pump, persons wearing a metal prosthesis or an intracerebral clip as well as claustrophobic subjects, neurosensory stimulator or implantable defibrillator, cochlear implants, ferromagnetic foreign body ocular or cerebral close to the nerve structures, agitation of the subject (non-cooperating or agitated subjects), ventriculoperitoneal neurosurgical bypass valves, dental apparatus.
About this study
Official title: Hierarchical Processing of Visual Movement
Little is known about the exact role of feedback in cortical processing. Hypotheses on its function range from attentional control to the transmission of Bayesian priors in the interpretation of sensory events, such as in the theory of Predictive Coding. Recent advances in identification of functional signatures of feedback and feedforward signal, as well as additional techniques based on causal relations in signal processing open a unique methodology for probing such processes in awake and behaving organisms and testing these theories and more generally the hierarchical processing between cortical areas.
The objective of this project is to study feedback and feedforward relations and localization in the well established pathways between cortical areas V1 and Medial Temporal (MT) that have been implicated in early integration processes in motion perception.
- Conditions
- Neurologic Signs
- Being tested
- functional Magnetic Resonance Imaging
- Keywords
- Vision, perception, BOLD activity
- Medical subject headings
- Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional Magnetic Resonance ImagingDevice
In a 2-hour session, the subject we be shown different control and experimental conditions (all being visual stimuli) in perceptive tasks.
| Study group | Role | What they receive |
|---|---|---|
| healthy subjects | Experimental | 25 healthy subjects with a normal/corrected vision fitting to all of the inclusion/exclusion criteria. All the subjects will be tested on the same visual stimuli, leading to intrasubject comparison analyses of functional magnetic resonance imaging (fMRI) activity between conditions. Receives: Device: functional Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-invasive Blood oxygenation level dependent (BOLD) fMRI activity
Blood oxygenation level dependent (BOLD) imaging is the standard technique used to generate images in fMRI studies, and relies on regional differences in cerebral blood flow to delineate regional activity. This non-invasive technic is not inducing any particular risk. The non invasive BOLD fMRI activity will be recorded in healthy subjects during a task of visual perception.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start22 Jul 2019
- Primary completion17 Feb 2021
- Study completion17 Feb 2021
Why it stopped: abandonment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic SignsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905616
- Sponsor's protocol ID
- 69HCL18_0933
- Other IDs
- 2019-A00465-52
- Acronym
- HIERARCHY
- Status last verified
- Feb 2021
- First submitted
- 4 Apr 2019
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hierarchical Processing of Visual Movement
- ClinicalTrials.gov ID
- NCT03905616
- Acronym / sponsor ID
- HIERARCHY / 69HCL18_0933
- Conditions
- Neurologic Signs
- Keywords
- Vision, perception, BOLD activity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: abandonment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 17 Feb 2021 (actual)
- Study completion
- 17 Feb 2021 (actual)
- First posted
- 5 Apr 2019 (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.
Little is known about the exact role of feedback in cortical processing. Hypotheses on its function range from attentional control to the transmission of Bayesian priors in the interpretation of sensory events, such as in the theory of Predictive Coding. Recent advances in identification of functional signatures of feedback and feedforward signal, as well as additional techniques based on causal relations in signal processing open a unique methodology for probing such processes in awake and behaving organisms and testing these theories and more generally the hierarchical processing between cortical areas.
The objective of this project is to study feedback and feedforward relations and localization in the well established pathways between cortical areas V1 and Medial Temporal (MT) that have been implicated in early integration processes in motion perception.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy subjects | Experimental | Device: functional Magnetic Resonance Imaging25 healthy subjects with a normal/corrected vision fitting to all of the inclusion/exclusion criteria. All the subjects will be tested on the same visual stimuli, leading to intrasubject comparison analyses of functional magnetic resonance imaging (fMRI) activity between conditions. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged between 18 and 40 years old
- Affiliated to a social security scheme
- Be right-handed
- Have signed the informed consent
Key exclusion criteria (7 listed)
- Subjects with a neurological or psychiatric history
- Subjects with visual disturbances not corrected
- Pregnant, lactating or childbearing women without contraception.
- Persons under guardianship, trusteeship or any other administrative or judicial measure of deprivation of rights or liberty, as well as adults protected by law.
- Participants refusing to be informed of the results of the medical examination.
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 |
|---|---|---|
| functional Magnetic Resonance ImagingIn a 2-hour session, the subject we be shown different control and experimental conditions (all being visual stimuli) in perceptive tasks. | Device | healthy subjects |
Primary outcome
Non-invasive Blood oxygenation level dependent (BOLD) fMRI activity
Time frame: At inclusion
Blood oxygenation level dependent (BOLD) imaging is the standard technique used to generate images in fMRI studies, and relies on regional differences in cerebral blood flow to delineate regional activity. This non-invasive technic is not inducing any particular risk. The non invasive BOLD fMRI activity will be recorded in healthy subjects during a task of visual perception.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing functional Magnetic Resonance Imaging in people with Neurologic Signs, run by Hospices Civils de Lyon.
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 7 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: withdrawn, as of the sponsor's last update on 25 Feb 2021. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Non-invasive Blood oxygenation level dependent (BOLD) fMRI activity (time frame: At inclusion). 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 25 Feb 2021.