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Clinical Trials/NCT06690125
NCT06690125
Completed
Not Applicable

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

Universita di Verona1 site in 1 country36 target enrollmentNovember 7, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neglect, Hemispatial
Sponsor
Universita di Verona
Enrollment
36
Locations
1
Primary Endpoint
Multisensory Computerized Test
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 7, 2018
End Date
September 2, 2021
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Universita di Verona
Responsible Party
Principal Investigator
Principal Investigator

Valentina Varalta

Doctor

Universita di Verona

Eligibility Criteria

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

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Mini Mental State Examination (MMSE)(During the assessment required for the neuropsychological evaluation of the patient, conducted as per standard clinical practice upon admission to the ward.)
  • Apple Cancellation Test(The assessment is conducted within a week of admission to the ward.)
  • Line Bisection Test(The assessment is conducted within a week of admission to the ward.)
  • Catherine Bergego Scale (CBS)(The assessment is conducted within a week of admission to the ward.)
  • Visual neglect test(The assessment is conducted within a week of admission to the ward.)
  • Tactile neglect test(The assessment is conducted within a week of admission to the ward.)

Study Sites (1)

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