Right Hemispheric StrokeAPACS_NeuroNCT06297044
Neural and Cognitive Correlates of Pragmatic Abilities
An observational study of Right Hemispheric Stroke and Left Hemispheric Stroke, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
Trial summary
Pragmatics of language refers to the set of abilities that allow one to use and interpret language according to context and, in general, to communicate effectively. Disorders in the pragmatics of language are prevalent in various clinical populations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Right Hemispheric Stroke, Left Hemispheric Stroke, Traumatic Brain Injury
- What is being tested?
- Neuropsychological assessment
- How many people
- 324 participants
- Where
- 1 siteItaly
- Study dates
- 29 Mar 2018to 31 Dec 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Neurological patients and healthy individuals
Who may be able to join
- Presence of objective neuropsychological assessment using standardized tests used in clinical routine.
- Ability to knowingly provide written informed consent and , therefore preserved comprehension skills and good understanding of simple verbal requests (for the experimental phase).
- Being a native speaker of Italian.
Who cannot join
- Presence of disability that impairs participation in research.
- Insufficient knowledge of the Italian language.
- Refusal to participate in the research.
- Other relevant prior neurological or psychiatric conditions (other than those determining membership in the experimental group).
- Comorbidity of multiple conditions that would determine membership in more than one experimental group.
- Comorbidity with other neurological conditions.
- Presence of prior psychiatric conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neural and Cognitive Correlates of Pragmatic Communication Abilities
Pragmatics of language refers to the set of abilities that allow one to use and interpret language according to context and, in general, to communicate effectively. Disorders in the pragmatics of language are prevalent in various clinical populations. They are a cause of social withdrawal and worse quality of life, both for patients directly affected and for their family members. Despite this, this type of disorder is rarely considered in neuropsychological assessment and rehabilitation.
This study's objective is to characterize pragmatic deficits in various neurological populations, allowing for the most accurate diagnosis possible and leading to the planning of personalized and effective Rehabilitation Plans.
Read the detailed description
To delineate the pragmatic deficit profile for each pathology group, eligible participants will undergo a neuropsychological assessment, subdivided into as many sessions as per the participant's availability and tolerance.
Assessment tools will include:
- APACS (A test for the Assessment of Pragmatic Abilities and Cognitive Substrates; Arcara and Bambini, 2016)
- SET (Story-based Empathy Task, Dodich et al., 2015)
- COAST (Communication Outcome After Stroke, Bambini et al., 2016)
- PWB (Psychological Well-Being scales, Sirigatti et al., 2009)
- other neuropsychological assessment tools depending on the participant's pathology and routinely used in the clinical practice within the Institution.
Resulting test scores will be statistically analyze to provide pragmatic and cognitive profiles for each pathology.
- Conditions
- Right Hemispheric Stroke, Left Hemispheric Stroke, Traumatic Brain Injury, Right Hemispheric Brain Tumor, Left Hemispheric Brain Tumor, Mild Cognitive Impairment
- Being tested
- Neuropsychological assessment
- Medical subject headings
- Brain Injuries, Traumatic, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological assessmentOther
- APACS assessing various aspects of pragmatic communication abilities;
- SET assessing cognitive and emotional theory of mind;
- COAST assessing functional communication impairments in daily activities and their impact on the quality of life after the illness onset;
- PWB assessing the individual's perceived quality of life and psychological well-being;
- other neuropsychological assessment tools depending on the participant's pathology and routinely used in the clinical practice within the Institution.
| Study group | Role | What they receive |
|---|---|---|
| Right Hemispheric Stroke | Specific inclusion criteria for this participants' group are:
- unilateral right hemispheric lesion after an ischemic or hemorrhagic stroke.
There are no specific exclusion criteria for this participants' group (see general exclusion criteria).
Participants will undergo a detailed neuropsychological assessment as detailed in the study's detailed description and outcome measures sections. Receives: Other: Neuropsychological assessment | |
| Left Hemispheric Stroke | Specific inclusion criteria for this participants' group are:
- unilateral left hemispheric lesion after an ischemic or hemorrhagic stroke.
There are no specific exclusion criteria for this participants' group (see general exclusion criteria).
Participants will undergo a detailed neuropsychological assessment as detailed in the study's detailed description and outcome measures sections. Receives: Other: Neuropsychological assessment | |
| Traumatic Brain Injury | Specific inclusion criteria for this participants' group are:
* presence of a traumatic brain injury episode
* absence of previous neurological and psychiatric conditions.
There are no specific exclusion criteria for this participants' group (see general exclusion criteria).
Participants will undergo a detailed neuropsychological assessment as detailed in the study's detailed description and outcome measures sections. Receives: Other: Neuropsychological assessment | |
| Right Hemispheric Brain Tumor | Specific inclusion criteria for this participants' group are:
- unilateral right hemispheric brain tumor.
There are no specific exclusion criteria for this participants' group (see general exclusion criteria).
Participants will undergo a detailed neuropsychological assessment as detailed in the study's detailed description and outcome measures sections. Receives: Other: Neuropsychological assessment | |
| Left Hemispheric Brain Tumor | Specific inclusion criteria for this participants' group are:
- unilateral left hemispheric brain tumor.
There are no specific exclusion criteria for this participants' group (see general exclusion criteria).
Participants will undergo a detailed neuropsychological assessment as detailed in the study's detailed description and outcome measures sections. Receives: Other: Neuropsychological assessment | |
| Mild Cognitive Impairment | Specific inclusion criteria for this participants' group are:
* MCI diagnosis according to Petersen et al., 2006 criteria
* absence of previous neurological and psychiatric conditions.
There are no specific exclusion criteria for this participants' group (see general exclusion criteria).
Participants will undergo a detailed neuropsychological assessment as detailed in the study's detailed description and outcome measures sections. Receives: Other: Neuropsychological assessment | |
| Healthy Individuals | Specific inclusion criteria for this participants' group are:
- absence of neurological and psychiatric conditions.
There are no specific exclusion criteria for this participants' group (see general exclusion criteria).
Participants will undergo a detailed neuropsychological assessment as detailed in the study's detailed description and outcome measures sections. Receives: Other: Neuropsychological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pragmatic Profile
results at ASsessemnt of Pragmatics Abilities and Cognitive Substrates (APACS) test
Measured: after enrollmnet (T0)
Secondary outcomes (2)
Theory of Mind
Results at Story Empathy Test (SET) score
Measured: after enrollmnet (T0)
Functional Communication Abilities
Results at Communication Outcome After Stroke (COAST)
Measured: after enrollmnet (T0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start29 Mar 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Right Hemispheric StrokeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giorgio Arcara, Principal investigator, San Camillo IRCCS Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297044
- Sponsor's protocol ID
- 2017.20
- Acronym
- APACS_Neuro
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arcara G, Bambini V. A Test for the Assessment of Pragmatic Abilities and Cognitive Substrates (APACS): Normative Data and Psychometric Properties. Front Psychol. 2016 Feb 12;7:70. doi: 10.3389/fpsyg.2016.00070. eCollection 2016.
PubMed 26903894Bambini, V., Arcara, G., Aiachini, B., Cattani, B., Dichiarante, M. L., Moro, A., ... & Pistarini, C. (2017). Assessing functional communication: validation of the Italian versions of the Communication Outcome after Stroke (COAST) scales for speakers and caregivers. Aphasiology, 31(3), 332-358.
Dodich A, Cerami C, Canessa N, Crespi C, Iannaccone S, Marcone A, Realmuto S, Lettieri G, Perani D, Cappa SF. A novel task assessing intention and emotion attribution: Italian standardization and normative data of the Story-based Empathy Task. Neurol Sci. 2015 Oct;36(10):1907-12. doi: 10.1007/s10072-015-2281-3. Epub 2015 Jun 14.
PubMed 26072203Sirigatti, S., Stefanile, C., Giannetti, E., Iani, L., Penzo, I., & Mazzeschi, A. (2009). Assessment of factor structure of Ryff's Psychological Well-Being Scales in Italian adolescents. Bollettino di Psicologia Applicata, 259(56), 30-50.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural and Cognitive Correlates of Pragmatic Communication Abilities
- ClinicalTrials.gov ID
- NCT06297044
- Acronym / sponsor ID
- APACS_Neuro / 2017.20
- Conditions
- Right Hemispheric Stroke, Left Hemispheric Stroke, Traumatic Brain Injury, Right Hemispheric Brain Tumor, Left Hemispheric Brain Tumor, Mild Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- IRCCS San Camillo, Venezia, ItalyUniversity, hospital or other
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Mar 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.
Pragmatics of language refers to the set of abilities that allow one to use and interpret language according to context and, in general, to communicate effectively. Disorders in the pragmatics of language are prevalent in various clinical populations. They are a cause of social withdrawal and worse quality of life, both for patients directly affected and for their family members. Despite this, this type of disorder is rarely considered in neuropsychological assessment and rehabilitation.
This study's objective is to characterize pragmatic deficits in various neurological populations, allowing for the most accurate diagnosis possible and leading to the planning of personalized and effective Rehabilitation Plans.
Detailed description
To delineate the pragmatic deficit profile for each pathology group, eligible participants will undergo a neuropsychological assessment, subdivided into as many sessions as per the participant's availability and tolerance.
Assessment tools will include:
- APACS (A test for the Assessment of Pragmatic Abilities and Cognitive Substrates; Arcara and Bambini, 2016)
- SET (Story-based Empathy Task, Dodich et al., 2015)
- COAST (Communication Outcome After Stroke, Bambini et al., 2016)
- PWB (Psychological Well-Being scales, Sirigatti et al., 2009)
- other neuropsychological assessment tools depending on the participant's pathology and routinely used in the clinical practice within the Institution.
Resulting test scores will be statistically analyze to provide pragmatic and cognitive profiles for each pathology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Right Hemispheric Stroke | – | Other: Neuropsychological assessmentSpecific inclusion criteria for this participants' group are: - unilateral right hemispheric lesion after an ischemic or hemorrhagic stroke. There are no specific exclusion criteria for this participants' group (see general exclusion criteria). Participants will undergo a detailed neuropsychological assessment as detailed in the study's detailed description and outcome measures sections. |
| Left Hemispheric Stroke | – | Other: Neuropsychological assessmentSpecific inclusion criteria for this participants' group are: - unilateral left hemispheric lesion after an ischemic or hemorrhagic stroke. There are no specific exclusion criteria for this participants' group (see general exclusion criteria). Participants will undergo a detailed neuropsychological assessment as detailed in the study's detailed description and outcome measures sections. |
| Traumatic Brain Injury | – | Other: Neuropsychological assessmentSpecific inclusion criteria for this participants' group are: * presence of a traumatic brain injury episode * absence of previous neurological and psychiatric conditions. There are no specific exclusion criteria for this participants' group (see general exclusion criteria). Participants will undergo a detailed neuropsychological assessment as detailed in the study's detailed description and outcome measures sections. |
| Right Hemispheric Brain Tumor | – | Other: Neuropsychological assessmentSpecific inclusion criteria for this participants' group are: - unilateral right hemispheric brain tumor. There are no specific exclusion criteria for this participants' group (see general exclusion criteria). Participants will undergo a detailed neuropsychological assessment as detailed in the study's detailed description and outcome measures sections. |
| Left Hemispheric Brain Tumor | – | Other: Neuropsychological assessmentSpecific inclusion criteria for this participants' group are: - unilateral left hemispheric brain tumor. There are no specific exclusion criteria for this participants' group (see general exclusion criteria). Participants will undergo a detailed neuropsychological assessment as detailed in the study's detailed description and outcome measures sections. |
| Mild Cognitive Impairment | – | Other: Neuropsychological assessmentSpecific inclusion criteria for this participants' group are: * MCI diagnosis according to Petersen et al., 2006 criteria * absence of previous neurological and psychiatric conditions. There are no specific exclusion criteria for this participants' group (see general exclusion criteria). Participants will undergo a detailed neuropsychological assessment as detailed in the study's detailed description and outcome measures sections. |
| Healthy Individuals | – | Other: Neuropsychological assessmentSpecific inclusion criteria for this participants' group are: - absence of neurological and psychiatric conditions. There are no specific exclusion criteria for this participants' group (see general exclusion criteria). Participants will undergo a detailed neuropsychological assessment as detailed in the study's detailed description and outcome measures sections. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Neurological patients and healthy individuals
Key inclusion criteria (3 listed)
- Presence of objective neuropsychological assessment using standardized tests used in clinical routine.
- Ability to knowingly provide written informed consent and , therefore preserved comprehension skills and good understanding of simple verbal requests (for the experimental phase).
- Being a native speaker of Italian.
Key exclusion criteria (7 listed)
- Presence of disability that impairs participation in research.
- Insufficient knowledge of the Italian language.
- Refusal to participate in the research.
- Other relevant prior neurological or psychiatric conditions (other than those determining membership in the experimental group).
- Comorbidity of multiple conditions that would determine membership in more than one experimental group.
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 |
|---|---|---|
| Neuropsychological assessment* APACS assessing various aspects of pragmatic communication abilities; * SET assessing cognitive and emotional theory of mind; * COAST assessing functional communication impairments in daily activities and their impact on the quality of life after the illness onset; * PWB assessing the individual's perceived quality of life and psychological well-being; * other neuropsychological assessment tools depending on the participant's pathology and routinely used in the clinical practice within the Institution. | Other | Healthy Individuals, Left Hemispheric Brain Tumor, Left Hemispheric Stroke, Mild Cognitive Impairment, Right Hemispheric Brain Tumor, Right Hemispheric Stroke, Traumatic Brain Injury |
Primary outcome
Pragmatic Profile
Time frame: after enrollmnet (T0)
results at ASsessemnt of Pragmatics Abilities and Cognitive Substrates (APACS) test
2 secondary outcomes
Theory of Mind
Time frame: after enrollmnet (T0)
Functional Communication Abilities
Time frame: after enrollmnet (T0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Background: PubMed 26903894Arcara G, Bambini V. A Test for the Assessment of Pragmatic Abilities and Cognitive Substrates (APACS): Normative Data and Psychometric Properties. Front Psychol. 2016 Feb 12;7:70. doi: 10.3389/fpsyg.2016.00070. eCollection 2016.
- BackgroundBambini, V., Arcara, G., Aiachini, B., Cattani, B., Dichiarante, M. L., Moro, A., ... & Pistarini, C. (2017). Assessing functional communication: validation of the Italian versions of the Communication Outcome after Stroke (COAST) scales for speakers and caregivers. Aphasiology, 31(3), 332-358.
- Background: PubMed 26072203Dodich A, Cerami C, Canessa N, Crespi C, Iannaccone S, Marcone A, Realmuto S, Lettieri G, Perani D, Cappa SF. A novel task assessing intention and emotion attribution: Italian standardization and normative data of the Story-based Empathy Task. Neurol Sci. 2015 Oct;36(10):1907-12. doi: 10.1007/s10072-015-2281-3. Epub 2015 Jun 14.
- BackgroundSirigatti, S., Stefanile, C., Giannetti, E., Iani, L., Penzo, I., & Mazzeschi, A. (2009). Assessment of factor structure of Ryff's Psychological Well-Being Scales in Italian adolescents. Bollettino di Psicologia Applicata, 259(56), 30-50.
- Individual participant dataSharing planned: No
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.
Giorgio Arcara principal investigator
San Camillo IRCCS Hospital
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 Right Hemispheric Stroke and Left Hemispheric Stroke, run by IRCCS San Camillo, Venezia, Italy 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 6 Mar 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?
Results are not available in the source record.
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?
Pragmatic Profile (time frame: after enrollmnet (T0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06297044, which also lists 4 linked publications.
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 6 Mar 2024.