CompletedNot Applicable

Therapy of Pragmatic Disorders in Brain-damaged Individuals

Switzerland2 participantsStarted 2020-06-03

Plain-language 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.

Who can participate

Age range

20 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

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

Trial details

NCT IDNCT04708561

SponsorUniversity of Neuchatel

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-31

View on ClinicalTrials.gov More Brain Injuries, Traumatic trials