Late Effects of Cerebrovascular AccidentstrokeNCT02897791
Main Idea Perception of Written Stories and in Pictures Among Impaired Right Hemisphere Patients
A study testing written evaluations in people with Late Effects of Cerebrovascular Accident, run by Sheba Medical Center.
Trial summary
Main idea perception of written stories and in pictures among impaired right hemisphere patients Abstract The right hemisphere is considered to complement the language processing abilities of the opposite hemisphere; it is responsible for the processing of secondary and unusual characteristics of linguistic… Read more about this study
- Who is it for?
- Ages 20 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Late Effects of Cerebrovascular Accident
- What is being tested?
- written evaluations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Sep 2017
- Phase
- Interventional
- 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 20 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- first stroke without primary diminutive impairment Hebrew as a first language
Who cannot join
- previous neurological illness irritable patient
About this study
Main idea perception of written stories and in pictures among impaired right hemisphere patients Abstract The right hemisphere is considered to complement the language processing abilities of the opposite hemisphere; it is responsible for the processing of secondary and unusual characteristics of linguistic stimulates. This processing enables, among other functions, the comprehension of metaphors and humor. Additionally, it enables the execution of inferring from spoken and written discourse. Studies which deal with common impairments among right-hemisphere-damaged (RHD) individuals, found that inference processing of written stories and narrative sequences presented in pictures was impaired. This impairment could damage the ability to create global coherence, which is an important component of central theme comprehension of different types of narrative. Another important component is superstructures, schemas which aid creating, remembering and producing the main ideas of spoken and written discourse. Other studies consider impairment in creating global coherence, or Theory of Mind impairment, as the source of central theme comprehension impairment among RHD individuals.
Discourse is an integral part of interpersonal communication, and of proper social conduct. The themes chosen for conversation reflect the functional role of discourse from semantic and pragmatic points of view.
Read more
The aim of the current study is to deepen the current knowledge concerning central theme comprehension among RHD individuals following cerebrovascular accident (CVA), in two genres of written discourse (classic stories and stories with a twist), and in situations represented by single pictures. Unlike written stories, the extraction of the central theme out of a single picture requires focusing on a single situation and relying on non-linguistic visual information. Differences concerning central theme comprehension in the different discourse genres and in the pictures might be able to assist in selecting diagnostic and therapeutic tools designed to work on high cognitive-linguistic abilities, which are usually impaired among RHD individuals. In later stage, these tools are meant to help improving RHD individuals' spontaneous narrative skills.
The study will include 20 RHD adults following CVA, and 20 healthy adults without any known damage to the right hemisphere. The two groups will be matched concerning sex, age, educational level and socio-economic status. The subjects will perform the study tests during three sessions, 60 minutes each. The screening tests will include language diagnosis - Western Aphasia Battery (WAB), and reading test no. 37 included in the Psycholinguistic Assessments of Language Processing in Aphasia's battery (PALPA). Patients diagnosed with aphasia will be excluded from research. The research tests will include: central theme comprehension test in stories and pictures, including classic stories, stories with a twist, and pictures of different situations (each will be accompanied by a multiple-choice question concerning the central theme), sub- exanimations taken from "Frigbi" battery designed to evaluate memory and phonological memory capacity, Raven's Progressive Colored Matrices test designed to evaluate pre-morbid abilities (non-linguistic), Theory of Mind (T.O.M) evaluation test, and tests designed to evaluate central coherence impairment: Navon Figures test for evaluation of global visual perception impairment, and Rey-Osterrieth Complex Figure Test (RCFT) - Recall Form test for evaluation of visual-perceptive organizational ability, and non-verbal memory. The performances of the two groups will be compared in each test using statistical tests. In addition, the interaction between all variables will be measured.
- Conditions
- Late Effects of Cerebrovascular Accident
- Being tested
- written evaluations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
written evaluationsBehavioural
answering questions about pictures and stories
| Study group | Role | What they receive |
|---|---|---|
| Impaired Rt. Hemisphere patients | Experimental | 20 first stroke patients Receives: Behavioral: written evaluations |
| control | Experimental | 20 healthy adults without any known damage to the right hemisphere. The two groups will be matched concerning sex, age, educational level and socio-economic status. Receives: Behavioral: written evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Picture and Story Comprehension Interview Score
Patients were administered the Picture and Story Comprehension Interview. This measure includes 12 short story items and 30 picture items. Regarding each item, patients were asked to choose the sentence that best represented the main idea of the picture or story (multiple choice questions). The interview score was computed as the sum of correct answers.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startAug 2015
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late Effects of Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Ofer Keren, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897791
- Sponsor's protocol ID
- SHEBA-14-1529-OK-CTIL
- Acronym
- stroke
- Status last verified
- Nov 2017
- First submitted
- 27 Jul 2016
- Last updated
- 22 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Main Idea Perception of Written Stories and in Pictures Among Impaired Right Hemisphere Patients
- ClinicalTrials.gov ID
- NCT02897791
- Acronym / sponsor ID
- stroke / SHEBA-14-1529-OK-CTIL
- Conditions
- Late Effects of Cerebrovascular Accident
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Aug 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 13 Sep 2016 (estimated)
- 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.
Main idea perception of written stories and in pictures among impaired right hemisphere patients Abstract The right hemisphere is considered to complement the language processing abilities of the opposite hemisphere; it is responsible for the processing of secondary and unusual characteristics of linguistic stimulates. This processing enables, among other functions, the comprehension of metaphors and humor. Additionally, it enables the execution of inferring from spoken and written discourse. Studies which deal with common impairments among right-hemisphere-damaged (RHD) individuals, found that inference processing of written stories and narrative sequences presented in pictures was impaired. This impairment could damage the ability to create global coherence, which is an important component of central theme comprehension of different types of narrative. Another important component is superstructures, schemas which aid creating, remembering and producing the main ideas of spoken and written discourse. Other studies consider impairment in creating global coherence, or Theory of Mind impairment, as the source of central theme comprehension impairment among RHD individuals.
Discourse is an integral part of interpersonal communication, and of proper social conduct. The themes chosen for conversation reflect the functional role of discourse from semantic and pragmatic points of view.
The aim of the current study is to deepen the current knowledge concerning central theme comprehension among RHD individuals following cerebrovascular accident (CVA), in two genres of written discourse (classic stories and stories with a twist), and in situations represented by single pictures. Unlike written stories, the extraction of the central theme out of a single picture requires focusing on a single situation and relying on non-linguistic visual information. Differences concerning central theme comprehension in the different discourse genres and in the pictures might be able to assist in selecting diagnostic and therapeutic tools designed to work on high cognitive-linguistic abilities, which are usually impaired among RHD individuals. In later stage, these tools are meant to help improving RHD individuals' spontaneous narrative skills.
The study will include 20 RHD adults following CVA, and 20 healthy adults without any known damage to the right hemisphere. The two groups will be matched concerning sex, age, educational level and socio-economic status. The subjects will perform the study tests during three sessions, 60 minutes each. The screening tests will include language diagnosis - Western Aphasia Battery (WAB), and reading test no. 37 included in the Psycholinguistic Assessments of Language Processing in Aphasia's battery (PALPA). Patients diagnosed with aphasia will be excluded from research. The research tests will include: central theme comprehension test in stories and pictures, including classic stories, stories with a twist, and pictures of different situations (each will be accompanied by a multiple-choice question concerning the central theme), sub- exanimations taken from "Frigbi" battery designed to evaluate memory and phonological memory capacity, Raven's Progressive Colored Matrices test designed to evaluate pre-morbid abilities (non-linguistic), Theory of Mind (T.O.M) evaluation test, and tests designed to evaluate central coherence impairment: Navon Figures test for evaluation of global visual perception impairment, and Rey-Osterrieth Complex Figure Test (RCFT) - Recall Form test for evaluation of visual-perceptive organizational ability, and non-verbal memory. The performances of the two groups will be compared in each test using statistical tests. In addition, the interaction between all variables will be measured.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Impaired Rt. Hemisphere patients | Experimental | Behavioral: written evaluations20 first stroke patients |
| control | Experimental | Behavioral: written evaluations20 healthy adults without any known damage to the right hemisphere. The two groups will be matched concerning sex, age, educational level and socio-economic status. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- first stroke without primary diminutive impairment Hebrew as a first language
Key exclusion criteria (1 listed)
- previous neurological illness irritable patient
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 |
|---|---|---|
| written evaluationsanswering questions about pictures and stories | Behavioural | Impaired Rt. Hemisphere patients, control |
Primary outcome
Picture and Story Comprehension Interview Score
Time frame: 1 hour
Patients were administered the Picture and Story Comprehension Interview. This measure includes 12 short story items and 30 picture items. Regarding each item, patients were asked to choose the sentence that best represented the main idea of the picture or story (multiple choice questions). The interview score was computed as the sum of correct answers.
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 22 Nov 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing written evaluations in people with Late Effects of Cerebrovascular Accident, run by Sheba Medical Center.
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 1 inclusion and 1 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 22 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Picture and Story Comprehension Interview Score (time frame: 1 hour). 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 22 Nov 2017.