Brain Injuries, TraumaticNCT04708561
Therapy of Pragmatic Disorders in Brain-damaged Individuals
A study testing Speech and language therapy in people with Brain Injuries, Traumatic and Right Hemispheric Stroke, run by University of Neuchatel at 1 site in Switzerland.
Trial summary
This study aims to assess speech therapy's effectiveness in understanding other people's thoughts (implied) using written stories. The main objective is to examine whether the therapy improves understanding of the stories worked on in the sessions. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Brain Injuries, Traumatic, Right Hemispheric Stroke
- What is being tested?
- Speech and language therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Jun 2020to 30 Apr 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have been the victim, in adulthood, of a moderate to severe traumatic brain injury (TBI) or a stroke, with at least right frontal lesions (objectified by imaging). The time between the TBI or stroke and participation in this study should be greater than six months.
- Be of French mother tongue or have an excellent mastery of French.
- Be between 20 and 65 years old.
- Be right-handed
- Present problems in the understanding of non-literal language (irony, indirect requests), objectified by a neuropsychological examination.
Who cannot join
- Have a history of psychiatric disorder affecting social cognition (according to DSM-V criteria), and more specifically: autism, schizophrenia, bipolar disorders, major depressive disorders, borderline personality disorders, generalized anxiety disorders, obsessive-compulsive disorders, phobia social and eating disorders (anorexia, bulimia).
- Have chronic symptoms of an alcohol or drug dependence disorder (according to DSM-V criteria).
- Have significant uncorrected vision and/or hearing problems.
- Have aphasia and/or significant reading and comprehension problems.
- Present significant spatial neglect.
- Present an impaired capacity for judgment and discernment, objectified by a neuropsychological evaluation.
- Have been the victim of several TBI or stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapy of Non-literal Language Comprehension Disorders in Brain-damaged Individuals: Case Studies
This study aims to assess speech therapy's effectiveness in understanding other people's thoughts (implied) using written stories. The main objective is to examine whether the therapy improves understanding of the stories worked on in the sessions. We also explore whether the observed progress is maintained one month after the end of treatment and whether it is generalized to neuropsychological tests, video material, and the participants' daily lives.
This therapy will be administered to four individuals with brain lesions, for six weeks, at the rate of two weekly sessions of one hour.
- Being tested
- Speech and language therapy
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech and language therapyBehavioural
The intervention focuses on understanding the thoughts of the characters. Twenty written stories will be used, which end with statements that can be interpreted literally, ironically, as a lie, a request or a faux-pas (maladroitness). At the end of each story, the participant should explain what the characters want to mean by their statement.
To help the participant in his understanding of the character's intention, he will be asked:
- To mention as many intentions as possible that can be associated with the target statement presented out of context (eg: "it's hot here" that can be interpreted literally, ironically, as a lie or a request) and to imagine contexts in connection with interpretation; 2. Analyze the relevant elements of the context (environment, the relationship between the characters, knowledge of the characters); 3. To judge the probability of the possible interpretations (pt 1) by justifying using the elements of the context analyzed previously (pt 2).
| Study group | Role | What they receive |
|---|---|---|
| Brain-injured participants | Experimental | Not described Receives: Behavioral: Speech and language therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from the score on the written task of comprehension of non-literal language 48 hours after the end of the therapy
The non-literal language comprehension task includes written stories ending with a character's utterance that can be interpreted literally (e.g., "I'm mad at you" to signify her nervousness); ironically (e.g. "it was a fantastic play" to mean the play was bad); as an indirect request (e.g., "Caramels look good" to ask for a caramel); like a lie (e.g. "it was very nice"); like a faux-pas (e.g., criticizing a person without knowing that he or she hears everything).
Following these stories, the participant must answer the question: "What does the character mean? ". Each story is scored 0-1-2 depending on the accuracy of the answer. The total score is thus obtained by adding the points received for each of the questions in the task's stories.
The stories will be administered twice before the therapy (baselines) and directly (24-48 hours) after the last session of the therapy to analyze the change of performance.
Measured: Baselines, 24-48 hours after the last session of the therapy
Change from the score on the written task of comprehension of non-literal language 1 month after the end of the therapy
The non-literal language comprehension task includes written stories ending with a character's utterance that can be interpreted literally (e.g., "I'm mad at you" to signify her nervousness); ironically (e.g. "it was a fantastic play" to mean the play was bad); as an indirect request (e.g., "Caramels look good" to ask for a caramel); like a lie (e.g. "it was very nice"); like a faux-pas (e.g., criticizing a person without knowing that he or she hears everything).
Following these stories, the participant must answer the question: "What does the character mean? ". Each story is scored 0-1-2 depending on the accuracy of the answer. The total score is thus obtained by adding the points received for each of the questions in the task's stories.
The stories will be administered twice before the therapy (baselines) and one month after the last session of the therapy to analyze the long-term change of performance.
Measured: Baselines, 1 month-follow-up
Maintenance from the score on the written task of comprehension of non-literal language 1 month after the end of the therapy
The non-literal language comprehension task includes written stories ending with a character's utterance that can be interpreted literally (e.g., "I'm mad at you" to signify her nervousness); ironically (e.g. "it was a fantastic play" to mean the play was bad); as an indirect request (e.g., "Caramels look good" to ask for a caramel); like a lie (e.g. "it was very nice"); like a faux-pas (e.g., criticizing a person without knowing that he or she hears everything).
Following these stories, the participant must answer the question: "What does the character mean? ". Each story is scored 0-1-2 depending on the accuracy of the answer. The total score is thus obtained by adding the points received for each of the questions in the task's stories.
The stories will be administered 24-48 hours and one month after the last session of the therapy to analyze the maintenance of performance.
Measured: 24-48 hours after the last session of the therapy, 1 month-follow-up
Secondary outcomes (24)
Change from a nonverbal test of theory of mind 48 hours after the end of the therapy
The nonverbal test of theory of mind (Sarfati et al., 1997) consists of choosing among 3 images (i.e., 3 intentions) the one that correctly ends the story.
The test will be administered before the therapy (baselines) and directly (24-48 hours) after the last session of the therapy to analyze the change of performance.
Measured: Baselines, 24-48 hours after the last session of the therapy
Change from a nonverbal test of theory of mind 1 month after the end of the therapy
The nonverbal test of theory of mind (Sarfati et al., 1997) consists of choosing among 3 images (i.e., 3 intentions) the one that correctly ends the story.
The test will be administered before the therapy (baselines) and one month after the last session of the therapy to analyze the long-term change of performance.
Measured: Baselines, 1 month-follow-up
Maintenance from a nonverbal test of theory of mind 1 month after the end of the therapy
The nonverbal test of theory of mind (Sarfati et al., 1997) consists of choosing among 3 images (i.e., 3 intentions) the one that correctly ends the story.
The test will be administered 24-48 hours and one month after the last session of the therapy to analyze the maintenance of performance.
Measured: 24-48 hours after the last session of the therapy, 1 month-follow-up
Change from a verbal test of theory of mind 48 hours after the end of the therapy
The verbal test of theory of mind (TOM-15; Desgranges et al., 2012) consists of reading a story and then answering a question about a character's false belief
The test will be administered before the therapy (baselines) and directly (24-48 hours) after the last session of the therapy to analyze the change of performance.
Measured: Baselines, 24-48 hours after the last session of the therapy
Change from a verbal test of theory of mind 1 month after the end of the therapy
The verbal test of theory of mind (TOM-15; Desgranges et al., 2012) consists of reading a story and then answering a question about a character's false belief
The test will be administered before the therapy (baselines) and one month after the last session of the therapy to analyze the long-term change of performance.
Measured: Baselines, 1 month-follow-up
Maintenance from a verbal test of theory of mind 1 month after the end of the therapy
The verbal test of theory of mind (TOM-15; Desgranges et al., 2012) consists of reading a story and then answering a question about a character's false belief
The test will be administered 24-48 hours and one month after the last session of the therapy to analyze the maintenance of performance.
Measured: 24-48 hours after the last session of the therapy, 1 month-follow-up
Change from a test of inhibitory control 48 hours after the end of the therapy
The test of inhibitory control (Hayling, Rouleau, 1998) consists in completing oral sentences with a word that is not semantically related.
The test will be administered before the therapy (baselines) and directly (24-48 hours) after the last session of the therapy to analyze the change of performance.
Measured: Baselines, 24-48 hours after the last session of the therapy
Change from a test of inhibitory control 1 month after the end of the therapy
The test of inhibitory control (Hayling, Rouleau, 1998) consists in completing oral sentences with a word that is not semantically related.
The test will be administered before the therapy (baselines) and one month after the last session of the therapy to analyze the long-term change of performance.
Measured: Baselines, 1 month-follow-up
Maintenance from a test of inhibitory control 1 month after the end of the therapy
The test of inhibitory control (Hayling, Rouleau, 1998) consists in completing oral sentences with a word that is not semantically related.
The test will be administered 24-48 hours and one month after the last session of the therapy to analyze the maintenance of performance.
Measured: 24-48 hours after the last session of the therapy, 1 month-follow-up
Change from a test of cognitive flexibility 48 hours after the end of the therapy
The test of inhibitory control (TrailMaking Test, Reitan \& Wolfson, 1993) consists of connecting by alternating numbers and letters in ascending and alphabetical order.
The test will be administered before the therapy (baselines) and directly (24-48 hours) after the last session of the therapy to analyze the change of performance.
Measured: Baselines, 24-48 hours after the last session of the therapy
Change from a test of cognitive flexibility 1 month after the end of the therapy
The test of inhibitory control (TrailMaking Test, Reitan \& Wolfson, 1993) consists of connecting by alternating numbers and letters in ascending and alphabetical order.
The test will be administered before the therapy (baselines) and one month after the last session of the therapy to analyze the long-term change of performance.
Measured: Baselines, 1 month-follow-up
Maintenance from a test of cognitive flexibility 1 month after the end of the therapy
The test of inhibitory control (TrailMaking Test, Reitan \& Wolfson, 1993) consists of connecting by alternating numbers and letters in ascending and alphabetical order.
The test will be administered 24-48 hours and one month after the last session of the therapy to analyze the maintenance of performance.
Measured: 24-48 hours after the last session of the therapy, 1 month-follow-up
Change from a test of working memory 48 hours after the end of the therapy
In this test (PASAT, Gronwall, 1977), the participant hears numbers and must add each new number heard to the previous one.
The test will be administered before the therapy (baselines) and directly (24-48 hours) after the last session of the therapy to analyze the change of performance.
Measured: Baselines, 24-48 hours after the last session of the therapy
Change from a test of working memory 1 month after the end of the therapy
In this test (PASAT, Gronwall, 1977), the participant hears numbers and must add each new number heard to the previous one.
The test will be administered before the therapy (baselines) and one month after the last session of the therapy to analyze the long-term change of performance.
Measured: Baselines, 1 month-follow-up
Maintenance from a test of working memory 1 month after the end of the therapy
In this test (PASAT, Gronwall, 1977), the participant hears numbers and must add each new number heard to the previous one.
The test will be administered 24-48 hours and one month after the last session of the therapy to analyze the maintenance of performance.
Measured: 24-48 hours after the last session of the therapy, 1 month-follow-up
Change from a video task of non-literal language comprehension 48 hours after the end of the therapy
This task includes 16 videos from TV shows. After each excerpt, the participant must explain what the actor wanted to mean by his statement.
The task will be administered before the therapy (baselines) and directly (24-48 hours) after the last session of the therapy to analyze the change of performance.
Measured: Baselines, 24-48 hours after the last session of the therapy
Change from a video task of non-literal language comprehension 1 month after the end of the therapy
This task includes 16 videos from TV shows. After each excerpt, the participant must explain what the actor wanted to mean by his statement.
The task will be administered before the therapy (baselines) and one month after the last session of the therapy to analyze the long-term change of performance.
Measured: Baselines, 1 month-follow-up
Maintenance from a video task of non-literal language comprehension 1 month after the end of the therapy
This task includes 16 videos from TV shows. After each excerpt, the participant must explain what the actor wanted to mean by his statement.
The test task will be administered 24-48 hours and one month after the last session of the therapy to analyze the maintenance of performance.
Measured: 24-48 hours after the last session of the therapy, 1 month-follow-up
Change from a daily life impact self-questionnaire 48 hours after the end of the therapy
The ERF-CS (Echelle de Répercussion Fonctionnelle des troubles de la Cognition Sociale; Peyroux \& Franck, 2014), administered to the participant, comprises 14 questions assessing four domains of social cognition: theory of mind, emotional processes, attributional style and social knowledge. The score range from 28 to 140 points. The higher the score, the greater the impact of the disorders is considered.
The questionnaire will be administered before the therapy (baselines) and directly (24-48 hours) after the last session of the therapy to analyze the change of performance.
Measured: Baselines, 24-48 hours after the last session of the therapy
Change from a daily life impact self-questionnaire 1 month after the end of the therapy
The ERF-CS (Echelle de Répercussion Fonctionnelle des troubles de la Cognition Sociale; Peyroux \& Franck, 2014), administered to the participant, comprises 14 questions assessing four domains of social cognition: theory of mind, emotional processes, attributional style and social knowledge. The score range from 28 to 140 points. The higher the score, the greater the impact of the disorders is considered.
The questionnaire will be administered before the therapy (baselines) and one month after the last session of the therapy to analyze the long-term change of performance.
Measured: Baselines, 1 month-follow-up
Maintenance from a daily life impact self-questionnaire 1 month after the end of the therapy
The ERF-CS (Echelle de Répercussion Fonctionnelle des troubles de la Cognition Sociale; Peyroux \& Franck, 2014), administered to the participant, comprises 14 questions assessing four domains of social cognition: theory of mind, emotional processes, attributional style and social knowledge. The score range from 28 to 140 points.. The higher the score, the greater the impact of the disorders is considered.
The questionnaire will be administered 24-48 hours and one month after the last session of the therapy to analyze the maintenance of performance.
Measured: 24-48 hours after the last session of the therapy, 1 month-follow-up
Change from a daily life impact hetero-questionnaire 48 hours after the end of the therapy
The questionnaire (Taché, 2014), administered to someone close to the participant, includes 24 questions aimed at evaluating three areas of the theory of mind: social participation, conversation management and perspective taking. The score range from 24 to 96 points. The lower the score, the greater the impact of the disorders is considered.
The questionnaire will be administered before the therapy (baselines) and directly (24-48 hours) after the last session of the therapy to analyze the change of performance.
Measured: Baselines, 24-48 hours after the last session of the therapy
Change from a daily life impact hetero-questionnaire 1 month after the end of the therapy
The questionnaire (Taché, 2014), administered to someone close to the participant, includes 24 questions aimed at evaluating three areas of the theory of mind: social participation, conversation management and perspective taking. The score range from 24 to 96 points. The lower the score, the greater the impact of the disorders is considered.
The questionnaire will be administered before the therapy (baselines) and one month after the last session of the therapy to analyze the long-term change of performance.
Measured: Baselines, 1 month-follow-up
Maintenance from a daily life impact hetero-questionnaire 1 month after the end of the therapy
The questionnaire (Taché, 2014), administered to someone close to the participant, includes 24 questions aimed at evaluating three areas of the theory of mind: social participation, conversation management and perspective taking. The score range from 24 to 96 points. The lower the score, the greater the impact of the disorders is considered.
The questionnaire will be administered 24-48 hours and one month after the last session of the therapy to analyze the maintenance of performance.
Measured: 24-48 hours after the last session of the therapy, 1 month-follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start3 Jun 2020
- Primary completion31 Oct 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Neuchatel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marion Fossard, University of Neuchatel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708561
- Sponsor's protocol ID
- Unine2020-00301
- Status last verified
- May 2022
- First submitted
- 7 Jan 2021
- Last updated
- 18 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapy of Non-literal Language Comprehension Disorders in Brain-damaged Individuals: Case Studies
- ClinicalTrials.gov ID
- NCT04708561
- Acronym / sponsor ID
- Unine2020-00301
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of NeuchatelUniversity, hospital or other
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 14 Jan 2021 (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.
This study aims to assess speech therapy's effectiveness in understanding other people's thoughts (implied) using written stories. The main objective is to examine whether the therapy improves understanding of the stories worked on in the sessions. We also explore whether the observed progress is maintained one month after the end of treatment and whether it is generalized to neuropsychological tests, video material, and the participants' daily lives.
This therapy will be administered to four individuals with brain lesions, for six weeks, at the rate of two weekly sessions of one hour.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain-injured participants | Experimental | Behavioral: Speech and language therapy |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have been the victim, in adulthood, of a moderate to severe traumatic brain injury (TBI) or a stroke, with at least right frontal lesions (objectified by imaging). The time between the TBI or stroke and participation in this study should be greater than six months.
- Be of French mother tongue or have an excellent mastery of French.
- Be between 20 and 65 years old.
- Be right-handed
- Present problems in the understanding of non-literal language (irony, indirect requests), objectified by a neuropsychological examination.
Key exclusion criteria (7 listed)
- Have a history of psychiatric disorder affecting social cognition (according to DSM-V criteria), and more specifically: autism, schizophrenia, bipolar disorders, major depressive disorders, borderline personality disorders, generalized anxiety disorders, obsessive-compulsive disorders, phobia social and eating disorders (anorexia, bulimia).
- Have chronic symptoms of an alcohol or drug dependence disorder (according to DSM-V criteria).
- Have significant uncorrected vision and/or hearing problems.
- Have aphasia and/or significant reading and comprehension problems.
- Present significant spatial neglect.
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 |
|---|---|---|
| Speech and language therapyThe intervention focuses on understanding the thoughts of the characters. Twenty written stories will be used, which end with statements that can be interpreted literally, ironically, as a lie, a request or a faux-pas (maladroitness). At the end of each story, the participant should explain what the characters want to mean by their statement. To help the participant in his understanding of the character's intention, he will be asked: 1) To mention as many intentions as possible that can be associated with the target statement presented out of context (eg: "it's hot here" that can be interpreted literally, ironically, as a lie or a request) and to imagine contexts in connection with interpretation; 2. Analyze the relevant elements of the context (environment, the relationship between the characters, knowledge of the characters); 3. To judge the probability of the possible interpretations (pt 1) by justifying using the elements of the context analyzed previously (pt 2). | Behavioural | Brain-injured participants |
Primary outcome
Change from the score on the written task of comprehension of non-literal language 48 hours after the end of the therapy
Time frame: Baselines, 24-48 hours after the last session of the therapy
The non-literal language comprehension task includes written stories ending with a character's utterance that can be interpreted literally (e.g., "I'm mad at you" to signify her nervousness); ironically (e.g. "it was a fantastic play" to mean the play was bad); as an indirect request (e.g., "Caramels look good" to ask for a caramel); like a lie (e.g. "it was very nice"); like a faux-pas (e.g., criticizing a person without knowing that he or she hears everything). Following these stories, the participant must answer the question: "What does the character mean? ". Each story is scored 0-1-2 depending on the accuracy of the answer. The total score is thus obtained by adding the points received for each of the questions in the task's stories. The stories will be administered twice before the therapy (baselines) and directly (24-48 hours) after the last session of the therapy to analyze the change of performance.
Change from the score on the written task of comprehension of non-literal language 1 month after the end of the therapy
Time frame: Baselines, 1 month-follow-up
The non-literal language comprehension task includes written stories ending with a character's utterance that can be interpreted literally (e.g., "I'm mad at you" to signify her nervousness); ironically (e.g. "it was a fantastic play" to mean the play was bad); as an indirect request (e.g., "Caramels look good" to ask for a caramel); like a lie (e.g. "it was very nice"); like a faux-pas (e.g., criticizing a person without knowing that he or she hears everything). Following these stories, the participant must answer the question: "What does the character mean? ". Each story is scored 0-1-2 depending on the accuracy of the answer. The total score is thus obtained by adding the points received for each of the questions in the task's stories. The stories will be administered twice before the therapy (baselines) and one month after the last session of the therapy to analyze the long-term change of performance.
Maintenance from the score on the written task of comprehension of non-literal language 1 month after the end of the therapy
Time frame: 24-48 hours after the last session of the therapy, 1 month-follow-up
The non-literal language comprehension task includes written stories ending with a character's utterance that can be interpreted literally (e.g., "I'm mad at you" to signify her nervousness); ironically (e.g. "it was a fantastic play" to mean the play was bad); as an indirect request (e.g., "Caramels look good" to ask for a caramel); like a lie (e.g. "it was very nice"); like a faux-pas (e.g., criticizing a person without knowing that he or she hears everything). Following these stories, the participant must answer the question: "What does the character mean? ". Each story is scored 0-1-2 depending on the accuracy of the answer. The total score is thus obtained by adding the points received for each of the questions in the task's stories. The stories will be administered 24-48 hours and one month after the last session of the therapy to analyze the maintenance of performance.
24 secondary outcomes
Change from a nonverbal test of theory of mind 48 hours after the end of the therapy
Time frame: Baselines, 24-48 hours after the last session of the therapy
Change from a nonverbal test of theory of mind 1 month after the end of the therapy
Time frame: Baselines, 1 month-follow-up
Maintenance from a nonverbal test of theory of mind 1 month after the end of the therapy
Time frame: 24-48 hours after the last session of the therapy, 1 month-follow-up
Change from a verbal test of theory of mind 48 hours after the end of the therapy
Time frame: Baselines, 24-48 hours after the last session of the therapy
Change from a verbal test of theory of mind 1 month after the end of the therapy
Time frame: Baselines, 1 month-follow-up
Maintenance from a verbal test of theory of mind 1 month after the end of the therapy
Time frame: 24-48 hours after the last session of the therapy, 1 month-follow-up
Change from a test of inhibitory control 48 hours after the end of the therapy
Time frame: Baselines, 24-48 hours after the last session of the therapy
Change from a test of inhibitory control 1 month after the end of the therapy
Time frame: Baselines, 1 month-follow-up
Maintenance from a test of inhibitory control 1 month after the end of the therapy
Time frame: 24-48 hours after the last session of the therapy, 1 month-follow-up
Change from a test of cognitive flexibility 48 hours after the end of the therapy
Time frame: Baselines, 24-48 hours after the last session of the therapy
Change from a test of cognitive flexibility 1 month after the end of the therapy
Time frame: Baselines, 1 month-follow-up
Maintenance from a test of cognitive flexibility 1 month after the end of the therapy
Time frame: 24-48 hours after the last session of the therapy, 1 month-follow-up
Change from a test of working memory 48 hours after the end of the therapy
Time frame: Baselines, 24-48 hours after the last session of the therapy
Change from a test of working memory 1 month after the end of the therapy
Time frame: Baselines, 1 month-follow-up
Maintenance from a test of working memory 1 month after the end of the therapy
Time frame: 24-48 hours after the last session of the therapy, 1 month-follow-up
Change from a video task of non-literal language comprehension 48 hours after the end of the therapy
Time frame: Baselines, 24-48 hours after the last session of the therapy
Change from a video task of non-literal language comprehension 1 month after the end of the therapy
Time frame: Baselines, 1 month-follow-up
Maintenance from a video task of non-literal language comprehension 1 month after the end of the therapy
Time frame: 24-48 hours after the last session of the therapy, 1 month-follow-up
Change from a daily life impact self-questionnaire 48 hours after the end of the therapy
Time frame: Baselines, 24-48 hours after the last session of the therapy
Change from a daily life impact self-questionnaire 1 month after the end of the therapy
Time frame: Baselines, 1 month-follow-up
Maintenance from a daily life impact self-questionnaire 1 month after the end of the therapy
Time frame: 24-48 hours after the last session of the therapy, 1 month-follow-up
Change from a daily life impact hetero-questionnaire 48 hours after the end of the therapy
Time frame: Baselines, 24-48 hours after the last session of the therapy
Change from a daily life impact hetero-questionnaire 1 month after the end of the therapy
Time frame: Baselines, 1 month-follow-up
Maintenance from a daily life impact hetero-questionnaire 1 month after the end of the therapy
Time frame: 24-48 hours after the last session of the therapy, 1 month-follow-up
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 18 May 2022.
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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?
A study testing Speech and language therapy in people with Brain Injuries, Traumatic and Right Hemispheric Stroke, run by University of Neuchatel at 1 site in Switzerland.
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 5 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: finished, as of the sponsor's last update on 18 May 2022. 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 Switzerland. 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?
Change from the score on the written task of comprehension of non-literal language 48 hours after the end of the therapy (time frame: Baselines, 24-48 hours after the last session of the therapy). The study lists 3 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 18 May 2022.