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

NCT06690125 | Completed DMC

• 1 other identifier: 1975CESC
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Neglect, Hemispatial; Stroke Acute

Keywords

neglect; attention; awareness; multisensory integration

Outcome Measures

Primary Outcomes (2)

• Multisensory Computerized Test

  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

  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 Outcomes (7)

• Mini Mental State Examination (MMSE)

  The assessment is conducted within a week of 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.

Study Arms (2)

Patients with right hemisphere stroke (Without USN)

Diagnostic Test: Classical and computerized assessment

Patients with right hemisphere stroke (With USN)

Diagnostic Test: Classical and computerized assessment

Interventions

Classical and computerized assessment DIAGNOSTIC_TEST

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); Patients with right hemisphere stroke (Without USN)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione

Verona, verona, Italy

Location

MeSH Terms

Conditions

Perceptual Disorders; Stroke

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 15, 2024
• Study Start: November 7, 2018
• Primary Completion: September 26, 2020
• Study Completion: September 2, 2021
• Last Updated: November 15, 2024

Record last verified: 2018-11

Locations

IT (1)