NCT03931798

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2017

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2019

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

1.2 years

First QC Date

April 26, 2019

Last Update Submit

May 6, 2019

Conditions

Keywords

Unilateral spatial neglectExtrapersonal spaceNeuropsychology

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Treatment

EXPERIMENTAL

Healthy participants were administered the Visual Scanning Test

Diagnostic Test: Visual Scanning Test

Interventions

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.

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- healthy subjects of full age.

You may not qualify if:

  • past or present neurological diseases;
  • past or present psychiatric diseases;
  • presence of visual disturbances.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (46)

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  • Borsotti M, Mosca IE, Di Lauro F, Pancani S, Bracali C, Dore T, Macchi C, Cecchi F; IRCCS Don Gnocchi Stroke Group. The Visual Scanning Test: a newly developed neuropsychological tool to assess and target rehabilitation of extrapersonal visual unilateral spatial neglect. Neurol Sci. 2020 May;41(5):1145-1152. doi: 10.1007/s10072-019-04218-2. Epub 2020 Jan 2.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 26, 2019

First Posted

April 30, 2019

Study Start

November 2, 2015

Primary Completion

January 15, 2017

Study Completion

January 9, 2018

Last Updated

May 7, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

We didn't plan to share these data