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

NCT ID: NCT06690125

Last Updated: 2024-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-07

Study Completion Date

2021-09-02

Brief Summary

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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.

Detailed Description

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Conditions

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Neglect, Hemispatial Stroke Acute

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with right hemisphere stroke (Without USN)

Classical and computerized assessment

Intervention Type 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)

Classical and computerized assessment

Intervention Type 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)

Interventions

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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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universita di Verona

OTHER

Sponsor Role lead

Responsible Party

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Valentina Varalta

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione

Verona, verona, Italy

Site Status

Countries

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Italy

Other Identifiers

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1975CESC

Identifier Type: -

Identifier Source: org_study_id

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