Therapy of Pragmatic Disorders in Brain-damaged Individuals

Not Applicable

Completed

• Conditions: Brain Injuries, Traumatic; Right Hemispheric Stroke
• Interventions: Behavioral: Speech and language therapy

• Registration Number: NCT04708561
• Lead Sponsor: University of Neuchatel

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-03
• Study First Submitted: 2021-01-07
• Study First Submitted QC: 2021-01-11
• Study First Posted: 2021-01-14
• Primary Completion: 2021-10-31
• Study Completion: 2022-04-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brain-injured participants	Speech and language therapy	-

Primary Outcome Measures

Name	Time	Method
Change from the score on the written task of comprehension of non-literal language 48 hours after the end of the therapy	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Change from a nonverbal test of theory of mind 48 hours after the end of the therapy	Baselines, 24-48 hours after the last session 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.
Change from a nonverbal test of theory of mind 1 month after the end of the therapy	Baselines, 1 month-follow-up	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.
Maintenance from a nonverbal test of theory of mind 1 month after the end of the therapy	24-48 hours after the last session of the therapy, 1 month-follow-up	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.
Change from a verbal test of theory of mind 48 hours after the end of the therapy	Baselines, 24-48 hours after the last session 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.
Change from a verbal test of theory of mind 1 month after the end of the therapy	Baselines, 1 month-follow-up	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.
Maintenance from a verbal test of theory of mind 1 month after the end of the therapy	24-48 hours after the last session of the therapy, 1 month-follow-up	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.
Change from a test of inhibitory control 48 hours after the end of the therapy	Baselines, 24-48 hours after the last session 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.
Change from a test of inhibitory control 1 month after the end of the therapy	Baselines, 1 month-follow-up	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.
Maintenance from a test of inhibitory control 1 month after the end of the therapy	24-48 hours after the last session of the therapy, 1 month-follow-up	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.
Change from a test of cognitive flexibility 48 hours after the end of the therapy	Baselines, 24-48 hours after the last session 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.
Change from a test of cognitive flexibility 1 month after the end of the therapy	Baselines, 1 month-follow-up	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.
Maintenance from a test of cognitive flexibility 1 month after the end of the therapy	24-48 hours after the last session of the therapy, 1 month-follow-up	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.
Change from a test of working memory 48 hours after the end of the therapy	Baselines, 24-48 hours after the last session 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.
Change from a test of working memory 1 month after the end of the therapy	Baselines, 1 month-follow-up	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.
Maintenance from a test of working memory 1 month after the end of the therapy	24-48 hours after the last session of the therapy, 1 month-follow-up	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.
Change from a video task of non-literal language comprehension 48 hours after the end of the therapy	Baselines, 24-48 hours after the last session 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.
Change from a video task of non-literal language comprehension 1 month after the end of the therapy	Baselines, 1 month-follow-up	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.
Maintenance from a video task of non-literal language comprehension 1 month after the end of the therapy	24-48 hours after the last session of the therapy, 1 month-follow-up	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.
Change from a daily life impact self-questionnaire 48 hours after the end of the therapy	Baselines, 24-48 hours after the last session 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.
Change from a daily life impact self-questionnaire 1 month after the end of the therapy	Baselines, 1 month-follow-up	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.
Maintenance from a daily life impact self-questionnaire 1 month after the end of the therapy	24-48 hours after the last session of the therapy, 1 month-follow-up	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.
Change from a daily life impact hetero-questionnaire 48 hours after the end of the therapy	Baselines, 24-48 hours after the last session 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.
Change from a daily life impact hetero-questionnaire 1 month after the end of the therapy	Baselines, 1 month-follow-up	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.
Maintenance from a daily life impact hetero-questionnaire 1 month after the end of the therapy	24-48 hours after the last session of the therapy, 1 month-follow-up	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.

Trial Locations

Locations (1)

Université de Neuchâtel; 🇨🇭 Neuchâtel, Switzerland