Clinical trial NCT05656638: Treatment of Grammatical Time Marking in Post-Stroke Aphasia
Official title: Treatment of Grammatical Time Marking in Post-Stroke Aphasia: a Study of French-Speaking Subjects With Chronic Fluent and Non-fluent Aphasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injury, Vascular
Aphasia
Stroke
Lead sponsor: University of Neuchatel
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study aims to assess an individual or self-administered computer therapy's effectiveness in grammatical time marking. The main objective is to examine whether the therapy improves grammatical time marking of inflected verbs treated on the sessions. We also explore whether the observed progress can be transferred to untrained items, more ecological contexts and if is maintained two and four weeks after the end of treatment.

This therapy will be administered to six individuals with brain lesions after stroke. Four individuals will take part of the individual therapy and two individuals will take part of the self-administered computer therapy. The therapy will last one month, at the rate of three weekly sessions of approximately one hour.


Eligibility criteria: Inclusion Criteria:

* Have had an imaging-objectified stroke in adulthood that resulted in aphasia (fluent or non-fluent). The time between the stroke and participation in this study must be greater than 6 months.
* Be a native French speaker or have excellent mastery of French.
* Be between 18 and 75 years old.
* Present grammatical tense marking disorders objectified by language evaluation (deficit scores on the "Batterie d'Évaluation de la Production Syntaxique" (BEPS) verb flexion task, Monetta et al., 2018; and/or on the "Test d'expression morpho-syntaxique fine" (T.E.M.F.) active sentence production subtask, Bernaert-Paul and Simonin, 2011).

Exclusion Criteria:

* Present chronic symptoms of a substance use disorder as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria.
* Have significant uncorrected vision and/or hearing impairment.
* Have significant impairments in oral/written comprehension.
* Present apraxia of speech or a severe arthritic disorder
* Present hemineglect
* Present impaired judgment and discernment, objectified by a neuropsychological evaluation

Primary outcomes:
measure: Change from the score on an inflected verb production task after the end of the therapy: treated items
timeFrame: Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy)
measure: Change from time accuracy on a semantic narration task after the end of the therapy: treated semantic narrations
timeFrame: Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy)
measure: Change from the score on an inflected verb production task after the end of the therapy: untreated items
timeFrame: Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy)
measure: Change from time accuracy on a semantic narration task after the end of the therapy: untreated semantic narrations
timeFrame: Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy)
measure: Change from the score on an inflected verb production task 2 and 4 weeks after the end of the therapy: treated items
timeFrame: Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up
measure: Change from the score on an inflected verb production task 2 and 4 weeks after the end of the therapy: untreated items
timeFrame: Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up
measure: Change from time accuracy on a semantic narration task 2 and 4 weeks after the end of the therapy: treated semantic narrations
timeFrame: Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up
measure: Change from time accuracy on a semantic narration task 2 and 4 weeks after the end of the therapy: untreated semantic narrations
timeFrame: Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up
measure: Change from the score on an inflected verb production task 2 and 4 weeks after the end of the therapy: treated items
timeFrame: Baselines, 2-4 weeks follow-up
measure: Change from the score on an inflected verb production task 2 and 4 weeks after the end of the therapy: untreated items
timeFrame: Baselines, 2-4 weeks follow-up
measure: Change from time accuracy on a semantic narration task 2 and 4 weeks after the end of the therapy: treated semantic narrations
timeFrame: Baselines, 2-4 weeks follow-up
measure: Change from time accuracy on a semantic narration task 2 and 4 weeks after the end of the therapy: untreated semantic narrations
timeFrame: Baselines, 2-4 weeks follow-up
Secondary outcomes:
measure: Change from time accuracy on an episodic/procedural narration task after the end of the therapy
timeFrame: Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy)
measure: Change from time accuracy on an episodic/procedural narration task 2 and 4 weeks after the end of the therapy
timeFrame: Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up
measure: Change from time accuracy on an episodic/procedural narration task 2 and 4 weeks after the end of the therapy
timeFrame: Baselines, 2-4 weeks follow-up
measure: Change at a control task after the end of the therapy
timeFrame: Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy)
measure: Change at a control task 2 and 4 weeks after the end of the therapy
timeFrame: Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up
measure: Change at a control task 2 and 4 weeks after the end of the therapy
timeFrame: Baselines, 2-4 weeks follow-up
Other outcomes:
Locations:
city: Neuchâtel
country: Switzerland
facility: Université de Neuchâtel
Study officials:
References: