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临床试验/NCT04708561
NCT04708561已完成不适用

Therapy of Non-literal Language Comprehension Disorders in Brain-damaged Individuals: Case Studies

University of Neuchatel1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2020年6月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2
试验地点
1
主要终点
Change from the score on the written task of comprehension of non-literal language 48 hours after the end of the therapy

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

Brain-injured participants

Experimental

干预措施: Speech and language therapy (Behavioral)

结局指标

主要结局

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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Change from a daily life impact hetero-questionnaire 1 month after the end of the therapy(Baselines, 1 month-follow-up)
  • 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)
  • 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)
  • 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)
  • 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)
  • Change from a test of inhibitory control 1 month after the end of the therapy(Baselines, 1 month-follow-up)
  • 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)
  • 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)
  • Change from a test of cognitive flexibility 1 month after the end of the therapy(Baselines, 1 month-follow-up)
  • 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)
  • 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)
  • Change from a test of working memory 1 month after the end of the therapy(Baselines, 1 month-follow-up)
  • 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)
  • 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)
  • Change from a video task of non-literal language comprehension 1 month after the end of the therapy(Baselines, 1 month-follow-up)
  • 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)
  • 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)
  • Change from a daily life impact self-questionnaire 1 month after the end of the therapy(Baselines, 1 month-follow-up)
  • 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)
  • 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)

研究者

发起方
University of Neuchatel
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marion Fossard

Professor

University of Neuchatel

研究点 (1)

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