Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04708561
Other study ID # Unine2020-00301
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT04111549 - GOALS Cognitive Training Delivered to Aging Veterans in Person or Via Telehealth N/A
Recruiting NCT05097261 - Ketamine in Acute Brain Injury Patients. Phase 4
Completed NCT03504709 - REsting and Stimulus-based Paradigms to Detect Organized NetworkS and Predict Emergence of Consciousness
Recruiting NCT03899532 - Remote Ischemic Conditioning in Traumatic Brain Injury N/A
Completed NCT05057377 - Estimating Highest Capacity Performance During Evaluation of Walking for Individuals With Traumatic Brain Injury
Withdrawn NCT02776488 - Exogenous Sodium Lactate Infusion in Traumatic Brain Injury (ELI-TBI) Phase 2
Completed NCT02426749 - Treatment and Recovery Monitoring of Post TBI Symptoms N/A
Completed NCT01339702 - The EPIC Project: Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines
Recruiting NCT05977270 - The Effects of Lifebloom One on Physical Activity After Acquired Brain Injury N/A
Recruiting NCT04666766 - Detecting Traumatic Intracranial Hemorrhage With Microwaves and Biomarkers N/A
Active, not recruiting NCT04559724 - Gait Training Through a Novel Over-ground Wearable Robotic System in People With Pyramidal Hemisyndromes N/A
Not yet recruiting NCT04515420 - The Influence of Noradrenaline on Coagulation and Fibrinolysis in Severe Isolated Brain Injury
Not yet recruiting NCT05569993 - Glutamine and Traumatic Brain Injury Early Phase 1
Recruiting NCT04331392 - Online Memory Intervention for Individuals With Traumatic Brain Injury N/A
Completed NCT03727737 - Efficacy of Repetitive Transcranial Magnetic Stimulation for Improvement of Memory in Older Adults With TBI N/A
Completed NCT03153397 - Effect of Prebiotic Fiber- Enriched (scFOS) Enteral Feeding on the Microbiome in Neurological Injury Trauma Patients (PreFEED Microbiome Trial) N/A
Completed NCT02004080 - CREACTIVE - Collaborative REsearch on ACute Traumatic Brain Injury in intensiVe Care Medicine in Europe
Completed NCT01336413 - Neuroactive Steroids and Traumatic Brain Injury (TBI) in OEF/OIF Veterans Phase 2
Completed NCT04957563 - Clinical Utility of Olfactory Rehabilitation: Treatment for Pacients With Neurosensorial Anosmia N/A
Completed NCT05179330 - Visual Feedback in Lower Limb Rehabilitation N/A