Neglect, HemispatialNCT06690125
Multisensory Integration and Cognitive Awareness in Post-Stroke Unilateral Spatial Neglect
An observational study of Neglect, Hemispatial and Stroke Acute, run by Universita di Verona at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neglect, Hemispatial, Stroke Acute
- What is being tested?
- Classical and computerized assessment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 7 Nov 2018to 2 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stroke who have right hemisphere lesions and showed USN.
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione
Verona, verona
About this study
Official title: 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:
Read more
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
- Being tested
- Classical and computerized assessment
- Keywords
- neglect, attention, awareness, multisensory integration
- Medical subject headings
- Perceptual Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classical and computerized assessmentDiagnostic 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)
| Study group | Role | What they receive |
|---|---|---|
| Patients with right hemisphere stroke (Without USN) | Not described Receives: Diagnostic Test: Classical and computerized assessment | |
| Patients with right hemisphere stroke (With USN) | Not described Receives: Diagnostic Test: Classical and computerized assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
(Range: 0-30; higher score=best performance).
Measured: The assessment is conducted within a week of admission to the ward.
Apple Cancellation Test
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
Measured: The assessment is conducted within a week of admission to the ward.
Line Bisection Test
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.
Measured: The assessment is conducted within a week of admission to the ward.
Catherine Bergego Scale (CBS)
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.
Measured: The assessment is conducted within a week of admission to the ward.
Visual neglect test
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.
Measured: The assessment is conducted within a week of admission to the ward.
Mini Mental State Examination (MMSE)
(Range: 0-30; higher score=best performance).
Measured: 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
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.
Measured: The assessment is conducted within a week of admission to the ward.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start7 Nov 2018
- Primary completion26 Sep 2020
- Study completion2 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neglect, HemispatialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentina Varalta, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690125
- Sponsor's protocol ID
- 1975CESC
- Status last verified
- Nov 2018
- First submitted
- 30 Oct 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attention, Awareness, and Multisensory Integration in Patients with Unilateral Spatial Neglect Following Stroke
- ClinicalTrials.gov ID
- NCT06690125
- Acronym / sponsor ID
- 1975CESC
- Conditions
- Neglect, Hemispatial, Stroke Acute
- Keywords
- neglect, attention, awareness, multisensory integration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 26 Sep 2020 (actual)
- Study completion
- 2 Sep 2021 (actual)
- First posted
- 15 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stroke who have right hemisphere lesions and showed USN.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Classical and computerized assessmentPatients 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) | Diagnostic test | Patients with right hemisphere stroke (With USN), Patients with right hemisphere stroke (Without USN) |
Primary outcome
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.
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.
7 secondary outcomes
Mini Mental State Examination (MMSE)
Time frame: 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.
Line Bisection Test
Time frame: 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.
Visual neglect test
Time frame: 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.
Tactile neglect test
Time frame: The assessment is conducted within a week of admission to the ward.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neglect, Hemispatial and Stroke Acute, run by Universita di Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multisensory Computerized Test (time frame: The assessment is conducted within a week of admission to the ward.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.