Clinical trial NCT04708561: Therapy of Pragmatic Disorders in Brain-damaged Individuals
Official title: Therapy of Non-literal Language Comprehension Disorders in Brain-damaged Individuals: Case Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries, Traumatic
Right Hemispheric Stroke
Lead sponsor: University of Neuchatel
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 2
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from the score on the written task of comprehension of non-literal language 48 hours after the end of the therapy
timeFrame: Baselines, 24-48 hours after the last session of the therapy
measure: Change from the score on the written task of comprehension of non-literal language 1 month after the end of the therapy
timeFrame: Baselines, 1 month-follow-up
measure: Maintenance from the score on the written task of comprehension of non-literal language 1 month after the end of the therapy
timeFrame: 24-48 hours after the last session of the therapy, 1 month-follow-up
Secondary outcomes:
measure: Change from a nonverbal test of theory of mind 48 hours after the end of the therapy
timeFrame: Baselines, 24-48 hours after the last session of the therapy
measure: Change from a nonverbal test of theory of mind 1 month after the end of the therapy
timeFrame: Baselines, 1 month-follow-up
measure: Maintenance from a nonverbal test of theory of mind 1 month after the end of the therapy
timeFrame: 24-48 hours after the last session of the therapy, 1 month-follow-up
measure: Change from a verbal test of theory of mind 48 hours after the end of the therapy
timeFrame: Baselines, 24-48 hours after the last session of the therapy
measure: Change from a verbal test of theory of mind 1 month after the end of the therapy
timeFrame: Baselines, 1 month-follow-up
measure: Maintenance from a verbal test of theory of mind 1 month after the end of the therapy
timeFrame: 24-48 hours after the last session of the therapy, 1 month-follow-up
measure: Change from a test of inhibitory control 48 hours after the end of the therapy
timeFrame: Baselines, 24-48 hours after the last session of the therapy
measure: Change from a test of inhibitory control 1 month after the end of the therapy
timeFrame: Baselines, 1 month-follow-up
measure: Maintenance from a test of inhibitory control 1 month after the end of the therapy
timeFrame: 24-48 hours after the last session of the therapy, 1 month-follow-up
measure: Change from a test of cognitive flexibility 48 hours after the end of the therapy
timeFrame: Baselines, 24-48 hours after the last session of the therapy
measure: Change from a test of cognitive flexibility 1 month after the end of the therapy
timeFrame: Baselines, 1 month-follow-up
measure: Maintenance from a test of cognitive flexibility 1 month after the end of the therapy
timeFrame: 24-48 hours after the last session of the therapy, 1 month-follow-up
measure: Change from a test of working memory 48 hours after the end of the therapy
timeFrame: Baselines, 24-48 hours after the last session of the therapy
measure: Change from a test of working memory 1 month after the end of the therapy
timeFrame: Baselines, 1 month-follow-up
measure: Maintenance from a test of working memory 1 month after the end of the therapy
timeFrame: 24-48 hours after the last session of the therapy, 1 month-follow-up
measure: Change from a video task of non-literal language comprehension 48 hours after the end of the therapy
timeFrame: Baselines, 24-48 hours after the last session of the therapy
measure: Change from a video task of non-literal language comprehension 1 month after the end of the therapy
timeFrame: Baselines, 1 month-follow-up
measure: Maintenance from a video task of non-literal language comprehension 1 month after the end of the therapy
timeFrame: 24-48 hours after the last session of the therapy, 1 month-follow-up
measure: Change from a daily life impact self-questionnaire 48 hours after the end of the therapy
timeFrame: Baselines, 24-48 hours after the last session of the therapy
measure: Change from a daily life impact self-questionnaire 1 month after the end of the therapy
timeFrame: Baselines, 1 month-follow-up
measure: Maintenance from a daily life impact self-questionnaire 1 month after the end of the therapy
timeFrame: 24-48 hours after the last session of the therapy, 1 month-follow-up
measure: Change from a daily life impact hetero-questionnaire 48 hours after the end of the therapy
timeFrame: Baselines, 24-48 hours after the last session of the therapy
measure: Change from a daily life impact hetero-questionnaire 1 month after the end of the therapy
timeFrame: Baselines, 1 month-follow-up
measure: Maintenance from a daily life impact hetero-questionnaire 1 month after the end of the therapy
timeFrame: 24-48 hours after the last session of the therapy, 1 month-follow-up
Other outcomes:
Locations:
city: Neuchâtel
country: Switzerland
facility: Université de Neuchâtel
Study officials:
References: