Therapy of Pragmatic Disorders in Brain-damaged Individuals

NCT04708561 | Completed

• 1 other identifier: Unine2020-00301
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries, Traumatic; Right Hemispheric Stroke

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (24)

• 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

• Change from a nonverbal test of theory of mind 1 month after the end of the therapy

  Baselines, 1 month-follow-up

• 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

• 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

• Change from a verbal test of theory of mind 1 month after the end of the therapy

  Baselines, 1 month-follow-up

Study Arms (1)

Brain-injured participants

EXPERIMENTAL

Behavioral: Speech and language therapy

Interventions

Speech and language therapy BEHAVIORAL

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).

Brain-injured participants

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Neuchatel: lead

Study Sites (1)

Université de Neuchâtel

Neuchâtel, Switzerland

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 14, 2021
• Study Start: June 3, 2020
• Primary Completion: October 31, 2021
• Study Completion: April 30, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

CH (1)