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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03931798
Other study ID # IRCCSdongnocchi
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2, 2015
Est. completion date January 9, 2018

Study information

Verified date May 2019
Source Fondazione Don Carlo Gnocchi Onlus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date January 9, 2018
Est. primary completion date January 15, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- healthy subjects of full age.

Exclusion Criteria:

- past or present neurological diseases;

- past or present psychiatric diseases;

- presence of visual disturbances.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Visual Scanning 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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Fondazione Don Carlo Gnocchi Onlus Clinical Center Agoretis, Rehabilitation Istitute Santa Maria Bambina

References & Publications (45)

Appelros 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. — View Citation

Azouvi P, Olivier S, de Montety G, Samuel C, Louis-Dreyfus A, Tesio L. Behavioral assessment of unilateral neglect: study of the psychometric properties of the Catherine Bergego Scale. Arch Phys Med Rehabil. 2003 Jan;84(1):51-7. — View Citation

Barrett AM, Buxbaum LJ, Coslett HB, Edwards E, Heilman KM, Hillis AE, Milberg WP, Robertson IH. Cognitive rehabilitation interventions for neglect and related disorders: moving from bench to bedside in stroke patients. J Cogn Neurosci. 2006 Jul;18(7):1223-36. Review. — View Citation

Bartolomeo P, Chokron S. Left unilateral neglect or right hyperattention? Neurology. 1999 Dec 10;53(9):2023-7. — View Citation

Bartolomeo, P. (2014). The attention systems of the human brain. In Attention Disorders After Right Brain Damage (pp. 1-19). Springer, London.

Berti 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. — View Citation

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. — View Citation

Bjoertomt O, Cowey A, Walsh V. Spatial neglect in near and far space investigated by repetitive transcranial magnetic stimulation. Brain. 2002 Sep;125(Pt 9):2012-22. — View Citation

Bonato M, Deouell LY. Hemispatial neglect: computer-based testing allows more sensitive quantification of attentional disorders and recovery and might lead to better evaluation of rehabilitation. Front Hum Neurosci. 2013 May 1;7:162. doi: 10.3389/fnhum.2013.00162. eCollection 2013. — View Citation

Bonato M, Priftis K, Marenzi R, Umiltà C, Zorzi M. Deficits of contralesional awareness: a case study on what paper-and-pencil tests neglect. Neuropsychology. 2012 Jan;26(1):20-36. doi: 10.1037/a0025306. Epub 2011 Sep 5. — View Citation

Bonato M. Neglect and extinction depend greatly on task demands: a review. Front Hum Neurosci. 2012 Jul 17;6:195. doi: 10.3389/fnhum.2012.00195. eCollection 2012. — View Citation

Bourgeois A, Chica AB, Migliaccio R, Thiebaut de Schotten M, Bartolomeo P. Cortical control of inhibition of return: evidence from patients with inferior parietal damage and visual neglect. Neuropsychologia. 2012 Apr;50(5):800-9. doi: 10.1016/j.neuropsychologia.2012.01.014. Epub 2012 Jan 20. — View Citation

Bowen 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. Review. — View Citation

Butler BC, Eskes GA, Vandorpe RA. Gradients of detection in neglect: comparison of peripersonal and extrapersonal space. Neuropsychologia. 2004;42(3):346-58. — View Citation

Buxbaum 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. — View Citation

Capitani E, Laiacona M. Composite neuropsychological batteries and demographic correction: standardization based on equivalent scores, with a review of published data. The Italian Group for the Neuropsychological Study of Ageing. J Clin Exp Neuropsychol. 1997 Dec;19(6):795-809. — View Citation

Capitani E, Laiacona M. Outer and inner tolerance limits: their usefulness for the construction of norms and the standardization of neuropsychological tests. Clin Neuropsychol. 2017 Aug - Oct;31(6-7):1219-1230. doi: 10.1080/13854046.2017.1334830. Epub 2017 Jun 9. — View Citation

Capitani, E. (1997). Normative data and neuropsychological assessment. Common problems in clinical practice and research. Neuropsychological Rehabilitation, 7(4), 295-310.

Cipresso P, Pedroli E, Serino S, Semonella M, Tuena C, Colombo D, Pallavicini F, Riva G. Assessment of Unilateral Spatial Neglect Using a Free Mobile Application for Italian Clinicians. Front Psychol. 2018 Nov 22;9:2241. doi: 10.3389/fpsyg.2018.02241. eCollection 2018. — View Citation

Cocchini, G., Beschin, N., &Jehkonen, M. (2001). The Fluff Test: A simple task to assess body representation neglect. Neuropsychological Rehabilitation, 11(1), 17-31.

Coslett HB. Apraxia, Neglect, and Agnosia. Continuum (Minneap Minn). 2018 Jun;24(3, BEHAVIORAL NEUROLOGY AND PSYCHIATRY):768-782. doi: 10.1212/CON.0000000000000606. — View Citation

Cunningham LJ, O'Rourke K, Finlay C, Gallagher M. A preliminary investigation into the psychometric properties of the Dublin Extrapersonal Neglect Assessment (DENA): A novel screening tool for extrapersonal neglect. Neuropsychol Rehabil. 2017 Apr;27(3):349-368. doi: 10.1080/09602011.2015.1084334. Epub 2015 Sep 30. — View Citation

Danckert J, Ferber S. Revisiting unilateral neglect. Neuropsychologia. 2006;44(6):987-1006. Epub 2005 Nov 21. Review. — View Citation

Denes 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. — View Citation

Gainotti 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. Review. — View Citation

Gamberini L, Seraglia B, Priftis K. Processing of peripersonal and extrapersonal space using tools: evidence from visual line bisection in real and virtual environments. Neuropsychologia. 2008 Apr;46(5):1298-304. doi: 10.1016/j.neuropsychologia.2007.12.01 — View Citation

Hartmann M, Sommer NR, Diana L, Müri RM, Eberhard-Moscicka AK. Further to the right: Viewing distance modulates attentional asymmetries ('pseudoneglect') during visual exploration. Brain Cogn. 2019 Feb;129:40-48. doi: 10.1016/j.bandc.2018.11.008. Epub 201 — View Citation

Hasegawa C, Hirono N, Yamadori A. Discrepancy in unilateral spatial neglect between daily living and neuropsychological test situations: a single case study. Neurocase. 2011 Dec;17(6):518-26. doi: 10.1080/13554794.2010.547506. Epub 2011 Jun 27. — View Citation

Heilman KM, Van Den Abell T. Right hemisphere dominance for attention: the mechanism underlying hemispheric asymmetries of inattention (neglect). Neurology. 1980 Mar;30(3):327-30. — View Citation

Kerkhoff G, Schenk T. Rehabilitation of neglect: an update. Neuropsychologia. 2012 May;50(6):1072-9. doi: 10.1016/j.neuropsychologia.2012.01.024. Epub 2012 Jan 28. Review. — View Citation

Lindell AB, Jalas MJ, Tenovuo O, Brunila T, Voeten MJ, Hämäläinen H. Clinical assessment of hemispatial neglect: evaluation of different measures and dimensions. Clin Neuropsychol. 2007 May;21(3):479-97. — View Citation

Lupianez J, Klein RM, Bartolomeo P. Inhibition of return: Twenty years after. Cogn Neuropsychol. 2006 Oct 1;23(7):1003-14. doi: 10.1080/02643290600588095. — View Citation

Machner B, Könemund 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. — View Citation

Mesulam MM. Spatial attention and neglect: parietal, frontal and cingulate contributions to the mental representation and attentional targeting of salient extrapersonal events. Philos Trans R Soc Lond B Biol Sci. 1999 Jul 29;354(1387):1325-46. Review. Err — View Citation

Parton A, Malhotra P, Husain M. Hemispatial neglect. J Neurol Neurosurg Psychiatry. 2004 Jan;75(1):13-21. Review. — View Citation

Pedroli E, Serino S, Cipresso P, Pallavicini F, Riva G. Assessment and rehabilitation of neglect using virtual reality: a systematic review. Front Behav Neurosci. 2015 Aug 25;9:226. doi: 10.3389/fnbeh.2015.00226. eCollection 2015. Review. — View Citation

Posner MI, Walker JA, Friedrich FJ, Rafal RD. Effects of parietal injury on covert orienting of attention. J Neurosci. 1984 Jul;4(7):1863-74. — View Citation

Priftis K, Bonato M, Zorzi M, Umiltà C. Spatial and non-spatial aspects of neglect. Front Hum Neurosci. 2013 Feb 5;7:25. doi: 10.3389/fnhum.2013.00025. eCollection 2013. — View Citation

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. — View Citation

Rengachary J, d'Avossa G, Sapir A, Shulman GL, Corbetta M. Is the posner reaction time test more accurate than clinical tests in detecting left neglect in acute and chronic stroke? Arch Phys Med Rehabil. 2009 Dec;90(12):2081-8. doi: 10.1016/j.apmr.2009.07.014. — View Citation

Ten 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. — View Citation

Ten 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. — View Citation

Vallar 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. Review. — View Citation

Vallar, 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..

Wilks, S. S. (1941). Determination of sample sizes for setting tolerance limits. The Annals of Mathematical Statistics, 12(1), 91-96.

* Note: There are 45 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Clinical indexes were obtained after completing th edata collecyion, which lasted two years
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