Clinical trial NCT06690125: Multisensory Integration and Cognitive Awareness in Post-Stroke Unilateral Spatial Neglect
Official title: Attention, Awareness, and Multisensory Integration in Patients with Unilateral Spatial Neglect Following Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neglect, Hemispatial
Stroke Acute
Keywords: neglect
attention
awareness
multisensory integration
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stroke who have right hemisphere lesions and showed USN.

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.


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
* 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.

Primary outcomes:
measure: Multisensory Computerized Test
timeFrame: The assessment is conducted within a week of admission to the ward.
measure: Multisensory Computerized Test
timeFrame: 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:
measure: Mini Mental State Examination (MMSE)
timeFrame: The assessment is conducted within a week of admission to the ward.
measure: Apple Cancellation Test
timeFrame: The assessment is conducted within a week of admission to the ward.
measure: Line Bisection Test
timeFrame: The assessment is conducted within a week of admission to the ward.
measure: Catherine Bergego Scale (CBS)
timeFrame: The assessment is conducted within a week of admission to the ward.
measure: Visual neglect test
timeFrame: The assessment is conducted within a week of admission to the ward.
measure: Mini Mental State Examination (MMSE)
timeFrame: During the assessment required for the neuropsychological evaluation of the patient, conducted as per standard clinical practice upon admission to the ward.
measure: Tactile neglect test
timeFrame: The assessment is conducted within a week of admission to the ward.
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione
Study officials:
References: