Spatial NeglectVSTNCT03931798
The Visual Scanning Test: a Neuropsychological Tool to Assess Extrapersonal Visual Unilateral Spatial Neglect
A study testing Visual Scanning Test in people with Spatial Neglect, run by Fondazione Don Carlo Gnocchi ETS.
Trial summary
Presentation and standardization on a normative sample of a new neuropsychological tool to provide a quantitative assessment of visual unilateral spatial neglect in the extrapersonal portion of space. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spatial Neglect
- What is being tested?
- Visual Scanning Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2015to 9 Jan 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy subjects of full age.
Who cannot join
- past or present neurological diseases;
- past or present psychiatric diseases;
- presence of visual disturbances.
About this study
Presentation and standardization on a normative sample of a new neuropsychological tool to provide a quantitative assessment of visual unilateral spatial neglect in the extrapersonal portion of space.
Read the detailed description
Unilateral spatial neglect (USN) represents one of the most frequent and disabling neuropsychological consequences of acute brain damage. Patients with USN show an impaired ability to perceive sensory events and to perform actions in the contralesional side of the space, in absence of a lower-level sensory or motor deficit. Several studies found that controlesional USN is more frequent and more severe in right than left parietal damage and due to its prominent impairment, USN has broadly been studied in the visual modality (VUSN). VUSN can affect patient's own contralesional body (personal neglect), into the near space within reaching distance (peripersonal) or space beyond reaching distance (far extrapersonal space). Those portions of space may dissociate and patient may show extrapersonal VUSN without alterations on the other portions of space (i.e. personal and peripersonal). Traditional paper-and-pencil neuropsychological tests are useful and widely used to evaluate VUSN, even if several of them can provide an assessment of peripersonal VUSN. In fact, this portion of space can be assessed through line bisection, cancellation, or copy tasks which are normally completed within reaching distance. Instead, personal and extrapersonal neglect are less easily evaluated: this lack of assessment tools may lead to lower detection rates for USN in patients in clinical setting and lead to relevant clinical implications. Finally, paper-and-pencil tests can detect only a moderate or even severe deficit due to VUSN but not a mild impairment and they are not informative about patients' disability in natural setting. According to this limitations of traditional paper-and-pencil tests, several studies have shown that computerized reaction time tasks are more sensitive in the detection of lateralized spatial attention deficits in patients with mild or remitted VUSN. The primary aim of this study was to present and standardize a new neuropsychological tool to provide a quantitative assessment of VUSN in the extrapersonal portion of space.
The Visual Scanning Test (VST) involved a visual search for a target between similar visual distractors, projected in the far space, so as to simulate the search within a visual field. It is overall composed by four trials, each trial contained 20 cases and made up by 20 stimuli. On about the 80% of cases, the test provided the presence of target in the left, center or in right hemispace. In the remaining 20% of cases, the test provided the presence of a catch trial (absence of the target), to assess the presence of frontal disturbances or malingering. The test is constructed according to an increasing attentional load for the target on the left-hemispace. Participants, sitting in front a blank wall, were required to actively and free explore the projected visual field to search for the visual target, naming its identification (saying YES or NO). During the task, the examiner annotated the reaction times and the errors. From these data it was possible to get some informative indexes regarding the reaction times, the accuracy and the implicit learning of the progressive shift to the left of the target and the possible presence of asymmetry in the visual exploration.
- Conditions
- Spatial Neglect
- Being tested
- Visual Scanning Test
- Keywords
- Unilateral spatial neglect, Extrapersonal space, Neuropsychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Scanning TestDiagnostic test
The Visual Scanning Test (VST) involved a visual search for a target between similar visual distractors, projected in the far space, so as to simulate the search within a visual field. It is overall composed by four trials, each trial contained 20 cases and made up by 20 stimuli. On about the 80% of cases, the test provided the presence of target in the left, center or in right hemispace. In the remaining 20% of cases, the test provided the presence of a catch trial (absence of the target), to assess the presence of frontal disturbances or malingering. The test is constructed according to an increasing attentional load for the target on the left-hemispace. Participants, sitting in front a blank wall, were required to actively and free explore the projected visual field to search for the visual target, naming its identification (saying YES or NO). During the task, the examiner annotated the reaction times and the errors.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Healthy participants were administered the Visual Scanning Test Receives: Diagnostic Test: Visual Scanning Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores of clinical indexes due to the accuracy and the reaction times
From the obtained data it was possible to get some informative indexes regarding the reaction times, the accuracy and the implicit learning of the progressive shift to the left of the target and the possible presence of asymmetry in the visual exploration.
Measured: Clinical indexes were obtained after completing th edata collecyion, which lasted two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start2 Nov 2015
- Primary completion15 Jan 2017
- Study completion9 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (46)Papers the sponsor has linked to this study.
- Other trials for Spatial NeglectStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Rehabilitation Istitute Santa Maria Bambina, Clinical Center Agoretis
- Responsible party
- Principal investigator, Francesca Cecchi, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931798
- Sponsor's protocol ID
- IRCCSdongnocchi
- Acronym
- VST
- Status last verified
- May 2019
- First submitted
- 26 Apr 2019
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We didn't plan to share these data
Publications
Priftis K, Passarini L, Pilosio C, Meneghello F, Pitteri M. Visual Scanning Training, Limb Activation Treatment, and Prism Adaptation for Rehabilitating Left Neglect: Who is the Winner? Front Hum Neurosci. 2013 Jul 8;7:360. doi: 10.3389/fnhum.2013.00360. eCollection 2013.
PubMed 23847520Vallar G, Calzolari E. Unilateral spatial neglect after posterior parietal damage. Handb Clin Neurol. 2018;151:287-312. doi: 10.1016/B978-0-444-63622-5.00014-0.
PubMed 29519463Vallar, G., & Bolognini, N. (2014). Unilateral spatial neglect. In A. C. Nobre & S. Kastner (Eds.), Oxford library of psychology. The Oxford handbook of attention (pp. 972-1027). New York, NY, US: Oxford University Press..
Bisiach E, Vallar G, Perani D, Papagno C, Berti A. Unawareness of disease following lesions of the right hemisphere: anosognosia for hemiplegia and anosognosia for hemianopia. Neuropsychologia. 1986;24(4):471-82. doi: 10.1016/0028-3932(86)90092-8.
PubMed 3774133Ten Brink AF, Verwer JH, Biesbroek JM, Visser-Meily JMA, Nijboer TCW. Differences between left- and right-sided neglect revisited: A large cohort study across multiple domains. J Clin Exp Neuropsychol. 2017 Sep;39(7):707-723. doi: 10.1080/13803395.2016.1262333. Epub 2016 Dec 12.
PubMed 27951747Ten Brink AF, Biesbroek JM, Oort Q, Visser-Meily JMA, Nijboer TCW. Peripersonal and extrapersonal visuospatial neglect in different frames of reference: A brain lesion-symptom mapping study. Behav Brain Res. 2019 Jan 1;356:504-515. doi: 10.1016/j.bbr.2018.06.010. Epub 2018 Jun 22.
PubMed 29940260Bowen A, McKenna K, Tallis RC. Reasons for variability in the reported rate of occurrence of unilateral spatial neglect after stroke. Stroke. 1999 Jun;30(6):1196-202. doi: 10.1161/01.str.30.6.1196.
PubMed 10356099Denes G, Semenza C, Stoppa E, Lis A. Unilateral spatial neglect and recovery from hemiplegia: a follow-up study. Brain. 1982 Sep;105 (Pt 3):543-52. doi: 10.1093/brain/105.3.543.
PubMed 7104665Machner B, Konemund I, von der Gablentz J, Bays PM, Sprenger A. The ipsilesional attention bias in right-hemisphere stroke patients as revealed by a realistic visual search task: Neuroanatomical correlates and functional relevance. Neuropsychology. 2018 Oct;32(7):850-865. doi: 10.1037/neu0000493.
PubMed 30321035Gainotti G. The role of automatic orienting of attention towards ipsilesional stimuli in non-visual (tactile and auditory) neglect: a critical review. Cortex. 2010 Feb;46(2):150-60. doi: 10.1016/j.cortex.2009.04.006. Epub 2009 May 14.
PubMed 19501350Appelros P, Nydevik I, Karlsson GM, Thorwalls A, Seiger A. Assessing unilateral neglect: shortcomings of standard test methods. Disabil Rehabil. 2003 May 6;25(9):473-9. doi: 10.1080/0963828031000071714.
PubMed 12745942Buxbaum LJ, Ferraro MK, Veramonti T, Farne A, Whyte J, Ladavas E, Frassinetti F, Coslett HB. Hemispatial neglect: Subtypes, neuroanatomy, and disability. Neurology. 2004 Mar 9;62(5):749-56. doi: 10.1212/01.wnl.0000113730.73031.f4.
PubMed 15007125Danckert J, Ferber S. Revisiting unilateral neglect. Neuropsychologia. 2006;44(6):987-1006. doi: 10.1016/j.neuropsychologia.2005.09.004. Epub 2005 Nov 21.
PubMed 16300805Berti A, Smania N, Rabuffetti M, Ferrarin M, Spinazzola L, D'Amico A, Ongaro E, Allport A. Coding of far and near space during walking in neglect patients. Neuropsychology. 2002 Jul;16(3):390-9. doi: 10.1037//0894-4105.16.3.390.
PubMed 12146686Lindell AB, Jalas MJ, Tenovuo O, Brunila T, Voeten MJ, Hamalainen H. Clinical assessment of hemispatial neglect: evaluation of different measures and dimensions. Clin Neuropsychol. 2007 May;21(3):479-97. doi: 10.1080/13854040600630061.
PubMed 17455032
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Visual Scanning Test: a Neuropsychological Tool to Assess Extrapersonal Visual Unilateral Spatial Neglect
- ClinicalTrials.gov ID
- NCT03931798
- Acronym / sponsor ID
- VST / IRCCSdongnocchi
- Conditions
- Spatial Neglect
- Keywords
- Unilateral spatial neglect, Extrapersonal space, Neuropsychology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Rehabilitation Istitute Santa Maria Bambina, Clinical Center Agoretis
- Study start
- 2 Nov 2015 (actual)
- Primary completion
- 15 Jan 2017 (actual)
- Study completion
- 9 Jan 2018 (actual)
- First posted
- 30 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.
Presentation and standardization on a normative sample of a new neuropsychological tool to provide a quantitative assessment of visual unilateral spatial neglect in the extrapersonal portion of space.
Detailed description
Unilateral spatial neglect (USN) represents one of the most frequent and disabling neuropsychological consequences of acute brain damage. Patients with USN show an impaired ability to perceive sensory events and to perform actions in the contralesional side of the space, in absence of a lower-level sensory or motor deficit. Several studies found that controlesional USN is more frequent and more severe in right than left parietal damage and due to its prominent impairment, USN has broadly been studied in the visual modality (VUSN). VUSN can affect patient's own contralesional body (personal neglect), into the near space within reaching distance (peripersonal) or space beyond reaching distance (far extrapersonal space). Those portions of space may dissociate and patient may show extrapersonal VUSN without alterations on the other portions of space (i.e. personal and peripersonal). Traditional paper-and-pencil neuropsychological tests are useful and widely used to evaluate VUSN, even if several of them can provide an assessment of peripersonal VUSN. In fact, this portion of space can be assessed through line bisection, cancellation, or copy tasks which are normally completed within reaching distance. Instead, personal and extrapersonal neglect are less easily evaluated: this lack of assessment tools may lead to lower detection rates for USN in patients in clinical setting and lead to relevant clinical implications. Finally, paper-and-pencil tests can detect only a moderate or even severe deficit due to VUSN but not a mild impairment and they are not informative about patients' disability in natural setting. According to this limitations of traditional paper-and-pencil tests, several studies have shown that computerized reaction time tasks are more sensitive in the detection of lateralized spatial attention deficits in patients with mild or remitted VUSN. The primary aim of this study was to present and standardize a new neuropsychological tool to provide a quantitative assessment of VUSN in the extrapersonal portion of space.
The Visual Scanning Test (VST) involved a visual search for a target between similar visual distractors, projected in the far space, so as to simulate the search within a visual field. It is overall composed by four trials, each trial contained 20 cases and made up by 20 stimuli. On about the 80% of cases, the test provided the presence of target in the left, center or in right hemispace. In the remaining 20% of cases, the test provided the presence of a catch trial (absence of the target), to assess the presence of frontal disturbances or malingering. The test is constructed according to an increasing attentional load for the target on the left-hemispace. Participants, sitting in front a blank wall, were required to actively and free explore the projected visual field to search for the visual target, naming its identification (saying YES or NO). During the task, the examiner annotated the reaction times and the errors. From these data it was possible to get some informative indexes regarding the reaction times, the accuracy and the implicit learning of the progressive shift to the left of the target and the possible presence of asymmetry in the visual exploration.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Diagnostic Test: Visual Scanning TestHealthy participants were administered the Visual Scanning Test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy subjects of full age.
Key exclusion criteria (3 listed)
- past or present neurological diseases;
- past or present psychiatric diseases;
- presence of visual disturbances.
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 |
|---|---|---|
| Visual Scanning TestThe Visual Scanning Test (VST) involved a visual search for a target between similar visual distractors, projected in the far space, so as to simulate the search within a visual field. It is overall composed by four trials, each trial contained 20 cases and made up by 20 stimuli. On about the 80% of cases, the test provided the presence of target in the left, center or in right hemispace. In the remaining 20% of cases, the test provided the presence of a catch trial (absence of the target), to assess the presence of frontal disturbances or malingering. The test is constructed according to an increasing attentional load for the target on the left-hemispace. Participants, sitting in front a blank wall, were required to actively and free explore the projected visual field to search for the visual target, naming its identification (saying YES or NO). During the task, the examiner annotated the reaction times and the errors. | Diagnostic test | Treatment |
Primary outcome
Scores of clinical indexes due to the accuracy and the reaction times
Time frame: Clinical indexes were obtained after completing th edata collecyion, which lasted two years
From the obtained data it was possible to get some informative indexes regarding the reaction times, the accuracy and the implicit learning of the progressive shift to the left of the target and the possible presence of asymmetry in the visual exploration.
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 7 May 2019.
- Background: PubMed 23847520Priftis K, Passarini L, Pilosio C, Meneghello F, Pitteri M. Visual Scanning Training, Limb Activation Treatment, and Prism Adaptation for Rehabilitating Left Neglect: Who is the Winner? Front Hum Neurosci. 2013 Jul 8;7:360. doi: 10.3389/fnhum.2013.00360. eCollection 2013.
- Background: PubMed 29519463Vallar G, Calzolari E. Unilateral spatial neglect after posterior parietal damage. Handb Clin Neurol. 2018;151:287-312. doi: 10.1016/B978-0-444-63622-5.00014-0.
- BackgroundVallar, G., & Bolognini, N. (2014). Unilateral spatial neglect. In A. C. Nobre & S. Kastner (Eds.), Oxford library of psychology. The Oxford handbook of attention (pp. 972-1027). New York, NY, US: Oxford University Press..
- Background: PubMed 3774133Bisiach E, Vallar G, Perani D, Papagno C, Berti A. Unawareness of disease following lesions of the right hemisphere: anosognosia for hemiplegia and anosognosia for hemianopia. Neuropsychologia. 1986;24(4):471-82. doi: 10.1016/0028-3932(86)90092-8.
- Background: PubMed 27951747Ten Brink AF, Verwer JH, Biesbroek JM, Visser-Meily JMA, Nijboer TCW. Differences between left- and right-sided neglect revisited: A large cohort study across multiple domains. J Clin Exp Neuropsychol. 2017 Sep;39(7):707-723. doi: 10.1080/13803395.2016.1262333. Epub 2016 Dec 12.
- Background: PubMed 29940260Ten Brink AF, Biesbroek JM, Oort Q, Visser-Meily JMA, Nijboer TCW. Peripersonal and extrapersonal visuospatial neglect in different frames of reference: A brain lesion-symptom mapping study. Behav Brain Res. 2019 Jan 1;356:504-515. doi: 10.1016/j.bbr.2018.06.010. Epub 2018 Jun 22.
- Background: PubMed 10356099Bowen A, McKenna K, Tallis RC. Reasons for variability in the reported rate of occurrence of unilateral spatial neglect after stroke. Stroke. 1999 Jun;30(6):1196-202. doi: 10.1161/01.str.30.6.1196.
- Background: PubMed 7104665Denes G, Semenza C, Stoppa E, Lis A. Unilateral spatial neglect and recovery from hemiplegia: a follow-up study. Brain. 1982 Sep;105 (Pt 3):543-52. doi: 10.1093/brain/105.3.543.
- Background: PubMed 30321035Machner B, Konemund I, von der Gablentz J, Bays PM, Sprenger A. The ipsilesional attention bias in right-hemisphere stroke patients as revealed by a realistic visual search task: Neuroanatomical correlates and functional relevance. Neuropsychology. 2018 Oct;32(7):850-865. doi: 10.1037/neu0000493.
- Background: PubMed 19501350Gainotti G. The role of automatic orienting of attention towards ipsilesional stimuli in non-visual (tactile and auditory) neglect: a critical review. Cortex. 2010 Feb;46(2):150-60. doi: 10.1016/j.cortex.2009.04.006. Epub 2009 May 14.
- Background: PubMed 12745942Appelros P, Nydevik I, Karlsson GM, Thorwalls A, Seiger A. Assessing unilateral neglect: shortcomings of standard test methods. Disabil Rehabil. 2003 May 6;25(9):473-9. doi: 10.1080/0963828031000071714.
- Background: PubMed 15007125Buxbaum LJ, Ferraro MK, Veramonti T, Farne A, Whyte J, Ladavas E, Frassinetti F, Coslett HB. Hemispatial neglect: Subtypes, neuroanatomy, and disability. Neurology. 2004 Mar 9;62(5):749-56. doi: 10.1212/01.wnl.0000113730.73031.f4.
- Individual participant dataSharing planned: No. We didn't plan to share these data
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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 Visual Scanning Test in people with Spatial Neglect, run by Fondazione Don Carlo Gnocchi ETS.
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 1 inclusion and 3 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 7 May 2019. 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 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?
Scores of clinical indexes due to the accuracy and the reaction times (time frame: Clinical indexes were obtained after completing th edata collecyion, which lasted two years). 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 NCT03931798, which also lists 46 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 7 May 2019.