Therapy of Pragmatic Disorders in Brain-damaged Individuals

Brain Injuries, Traumatic Clinical Trial

Official title:

Therapy of Non-literal Language Comprehension Disorders in Brain-damaged Individuals: Case Studies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04708561
• Other study ID #: Unine2020-00301
• Status: Completed
• Phase: N/A
• Start date: June 3, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2022
• Source: University of Neuchatel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: April 30, 2022
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Right Hemispheric Stroke

Intervention

Behavioral:
• Speech and language therapy
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: 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).

Locations

Country	Name	City	State
Switzerland	Université de Neuchâtel	Neuchâtel

Sponsors (1)

Lead Sponsor	Collaborator
University of Neuchatel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baselines, 24-48 hours after the last session of the therapy
Primary	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.	Baselines, 1 month-follow-up
Primary	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.	24-48 hours after the last session of the therapy, 1 month-follow-up
Secondary	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.	Baselines, 24-48 hours after the last session of the therapy
Secondary	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.	Baselines, 1 month-follow-up
Secondary	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.	24-48 hours after the last session of the therapy, 1 month-follow-up
Secondary	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.	Baselines, 24-48 hours after the last session of the therapy
Secondary	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.	Baselines, 1 month-follow-up
Secondary	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.	24-48 hours after the last session of the therapy, 1 month-follow-up
Secondary	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.	Baselines, 24-48 hours after the last session of the therapy
Secondary	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.	Baselines, 1 month-follow-up
Secondary	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.	24-48 hours after the last session of the therapy, 1 month-follow-up
Secondary	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.	Baselines, 24-48 hours after the last session of the therapy
Secondary	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.	Baselines, 1 month-follow-up
Secondary	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.	24-48 hours after the last session of the therapy, 1 month-follow-up
Secondary	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.	Baselines, 24-48 hours after the last session of the therapy
Secondary	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.	Baselines, 1 month-follow-up
Secondary	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.	24-48 hours after the last session of the therapy, 1 month-follow-up
Secondary	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.	Baselines, 24-48 hours after the last session of the therapy
Secondary	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.	Baselines, 1 month-follow-up
Secondary	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.	24-48 hours after the last session of the therapy, 1 month-follow-up
Secondary	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.	Baselines, 24-48 hours after the last session of the therapy
Secondary	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.	Baselines, 1 month-follow-up
Secondary	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.	24-48 hours after the last session of the therapy, 1 month-follow-up
Secondary	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.	Baselines, 24-48 hours after the last session of the therapy
Secondary	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.	Baselines, 1 month-follow-up
Secondary	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.	24-48 hours after the last session of the therapy, 1 month-follow-up