Multisensory Integration and Cognitive Awareness in Post-Stroke Unilateral Spatial Neglect

November 12, 2024 updated by: Valentina Varalta, Universita di Verona

Attention, Awareness, and Multisensory Integration in Patients with Unilateral Spatial Neglect Following Stroke

The primary aim of this study is to investigate whether multisensory integration (MSI) mechanisms observed in patients with right hemisphere lesions without neglect remain intact compared to patients with Unilateral Spatial Neglect (USN).

This study also allows for a direct comparison between results from paper-based tests and computerized tests, as well as between patients with right hemisphere lesions without neglect and USN patients. The secondary objectives are:

To compare these results in order to obtain a more refined definition of USN at both the unisensory level (as computerized tests are rarely used in hospital settings but have proven effective in diagnosing USN) and the multisensory level (since USN is not generally tested in the auditory modality).

To measure eye movements in all patients in the study, as this can provide useful information for characterizing patient deficits.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Verona, Italy
        • Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with stroke who have right hemisphere lesions and showed USN.

Description

Inclusion Criteria:

  • Patients will be included in the study if they have:
  • Right hemisphere stroke
  • Presence of USN assessed through the Apple Cancellation
  • Age between 18 and 85 years
  • Signed informed consent
  • Both male and female participants

As a control group, patients will also be included if they have:

  • Right hemisphere stroke
  • Absence of USN assessed through the Apple Cancellation
  • Age between 18 and 85 years
  • Signed informed consent
  • Both male and female participants.

Exclusion Criteria:

  • Both patients with USN and control patients will be excluded if they:
  • Are minors
  • Are unable to give their consent to participate in the study
  • Have significant language deficits (production and comprehension) (e.g., unable to give a verbal response or understand instructions)
  • Have hemianopia
  • Have severe hearing impairments that cannot be corrected (e.g., with hearing aids)
  • Have severe uncorrected visual impairments (e.g., glaucoma)
  • Have a history of psychiatric disorders or substance abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with right hemisphere stroke (Without USN)
Diagnostic test: Classical and computerized assessment

Patients with right hemisphere stroke will undergo a battery of standardized paper-based tests, as part of routine clinical practice, including cognitive assessments.

Additionally, they will complete computerized tests involving the presentation of unisensory (Auditory or Visual Stimuli) and multisensory stimuli (visual and auditory stimuli)
Patients with right hemisphere stroke (With USN)
Diagnostic test: Classical and computerized assessment

Patients with right hemisphere stroke will undergo a battery of standardized paper-based tests, as part of routine clinical practice, including cognitive assessments.

Additionally, they will complete computerized tests involving the presentation of unisensory (Auditory or Visual Stimuli) and multisensory stimuli (visual and auditory stimuli)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multisensory Computerized Test
Time Frame: The assessment is conducted within a week of admission to the ward.

The test is structured into three tasks that characterize the patient's deficits through visual and auditory stimuli.

In Task 1, 100 light items are presented in two blocks of 50, while in Task 2, the patient interacts with 36 sound items in a single block. During these tasks, the patient, seated in front of the computer, must localize the sources of light and sound. The lights are generated on the screen using software like MATLAB, while sounds come from speakers mounted on the screen. The patient's responses are recorded via a microphone and noted by the experimenter using the keyboard.
The assessment is conducted within a week of admission to the ward.
Multisensory Computerized Test
Time Frame: Is conducted over a total of three different days, during which the patient will complete Task 3 in three separate sessions, one for each day.
In Task 3, the presentation occurs simultaneously, with 360 items distributed across 12 blocks of 30 items each, repeated over three days. In this case as well, the patient must localize the sources of light and sound. This integrated approach allows for a thorough evaluation of sensory localization abilities and analyzes the interaction between visual and auditory stimuli in the patient.
Is conducted over a total of three different days, during which the patient will complete Task 3 in three separate sessions, one for each day.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini Mental State Examination (MMSE)
Time Frame: The assessment is conducted within a week of admission to the ward.
(Range: 0-30; higher score=best performance).
The assessment is conducted within a week of admission to the ward.
Apple Cancellation Test
Time Frame: The assessment is conducted within a week of admission to the ward.

The Apple Cancellation Test is a neuropsychological assessment that evaluates visual attention and neglect, both egocentric and allocentric, particularly in patients with brain injuries. During the test, participants are presented with a sheet containing a grid with 15 apples per cell: three large (one without an opening, one with an opening on the left, and one with an opening on the right) and 12 small apples (four without openings, four with openings on the left, and four with openings on the right). Participants must cancel the target apples within a set time frame.

The total score is based on the number of targets canceled, with a maximum of 50 apples. Additionally, an asymmetry score for egocentric neglect is calculated, representing the difference between the number of targets selected on the right side (boxes 1-4) and the number of targets selected on the left side (boxes 7-10). Higher scores indicate better performance, while lower scores may suggest difficulties in attentio
The assessment is conducted within a week of admission to the ward.
Line Bisection Test
Time Frame: The assessment is conducted within a week of admission to the ward.
In the Line Bisection Test, the patient is asked to mark the midpoint on a series of lines. For each line, a score is assigned that ranges from 0 to 3: a score of 0 indicates an inaccurate indication, while higher scores (up to 3) indicate greater accuracy. The scores are summed to obtain an overall total that ranges from 0 to 9. Higher scores indicate the absence of asymmetry and greater precision in performance.
The assessment is conducted within a week of admission to the ward.
Catherine Bergego Scale (CBS)
Time Frame: The assessment is conducted within a week of admission to the ward.
The Catherine Bergego Scale (CBS) is a clinical tool for measuring unilateral spatial neglect in patients with brain injuries, assessing how it impacts daily activities. The scale includes 10 activities (e.g., body orientation, mobility, personal care), each rated on a score from 0 to 3, where 0 indicates no neglect and 3 indicates severe neglect. The total score ranges from 0 to 30: higher scores indicate greater severity of neglect.
The assessment is conducted within a week of admission to the ward.
Visual neglect test
Time Frame: The assessment is conducted within a week of admission to the ward.
Visual Field Testing: Assessing the ability to perceive visual stimuli in different quadrants can help identify neglect. Patients may be asked to report stimuli presented in specific visual fields, with significant omissions indicating neglect.
The assessment is conducted within a week of admission to the ward.
Mini Mental State Examination (MMSE)
Time Frame: During the assessment required for the neuropsychological evaluation of the patient, conducted as per standard clinical practice upon admission to the ward.
(Range: 0-30; higher score=best performance).
During the assessment required for the neuropsychological evaluation of the patient, conducted as per standard clinical practice upon admission to the ward.
Tactile neglect test
Time Frame: The assessment is conducted within a week of admission to the ward.
Tactile Extinction Test: Patients are touched on both sides of the body simultaneously and must report where they feel the touch. If they can only report touch on one side when both sides are stimulated, it indicates tactile extinction and suggests neglect.
The assessment is conducted within a week of admission to the ward.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universita di Verona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2018

Primary Completion (Actual)

September 26, 2020

Study Completion (Actual)

September 2, 2021

Study Registration Dates

First Submitted

October 30, 2024

First Submitted That Met QC Criteria

November 12, 2024

First Posted (Actual)

November 15, 2024

Study Record Updates

Last Update Posted (Actual)

November 15, 2024

Last Update Submitted That Met QC Criteria

November 12, 2024

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1975CESC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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