Treatment of Grammatical Time Marking in Post-Stroke Aphasia

NCT05656638 | Completed

• 1 other identifier: Unine2022-01807
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injury, Vascular; Aphasia; Stroke

Outcome Measures

Primary Outcomes (12)

• Change from the score on an inflected verb production task after the end of the therapy: treated items

  The inflected verb production task evaluates subject's ability to produce an inflected verb form according to time context given by a short sentence. The score is obtained by adding the points (0 or 1) obtained for each item and is calculated per time reference. The task will be administered three times before the therapy (baselines), once in the middle of the therapy (after 2 weeks of treatment) and directly (24-48 hours) after the last session of the therapy (post-treatment) to analyze the change of performance.

  Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy)

• Change from time accuracy on a semantic narration task after the end of the therapy: treated semantic narrations

  The semantic narration task evaluates subject's ability to produce inflected verb forms according to time context. Semantic narrations are based on imagined stories and according to a given temporal frame. This task includes 2 pictorial sequences per temporal reference. The accuracy of time marking in semantic narration task is calculated using ratios. The task will be administered three times before the therapy (baselines), once in the middle of the therapy (after 2 weeks of treatment) and directly (24-48 hours) after the last session of the therapy (post-treatment) to analyze the change of performance.

  Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy)

• Change from the score on an inflected verb production task after the end of the therapy: untreated items

  The inflected verb production task evaluates subject's ability to produce an inflected verb form according to time context given by a short sentence. The score is obtained by adding the points (0 or 1) obtained for each item and is calculated per time reference. The task will be administered three times before the therapy (baselines), once in the middle of the therapy (after 2 weeks of treatment) and directly (24-48 hours) after the last session of the therapy (post-treatment) to analyze the change of performance.

  Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy)

• Change from time accuracy on a semantic narration task after the end of the therapy: untreated semantic narrations

  The semantic narration task evaluates subject's ability to produce inflected verb forms according to time context. Semantic narrations are based on imagined stories and according to a given temporal frame. This task includes 2 pictorial sequences per temporal reference. The accuracy of time marking in semantic narration task is calculated using ratios. The task will be administered three times before the therapy (baselines), once in the middle of the therapy (after 2 weeks of treatment) and directly (24-48 hours) after the last session of the therapy (post-treatment) to analyze the change of performance.

  Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy)

• Change from the score on an inflected verb production task 2 and 4 weeks after the end of the therapy: treated items

  The inflected verb production task evaluates subject's ability to produce an inflected verb form according to time context given by a short sentence. The score is obtained by adding the points (0 or 1) obtained for each item and is calculated per time reference. The task will be administered directly (24-48 hours) after the last session of the therapy (post-treatment) and 2-4 weeks after the treatment (follow-up) to analyze the maintenance of performance.

  Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up

• Change from the score on an inflected verb production task 2 and 4 weeks after the end of the therapy: untreated items

  The inflected verb production task evaluates subject's ability to produce an inflected verb form according to time context given by a short sentence. The score is obtained by adding the points (0 or 1) obtained for each item and is calculated per time reference. The task will be administered directly (24-48 hours) after the last session of the therapy (post-treatment) and 2-4 weeks after the treatment (follow-up) to analyze the maintenance of performance.

  Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up

• Change from time accuracy on a semantic narration task 2 and 4 weeks after the end of the therapy: treated semantic narrations

  The semantic narration task evaluates subject's ability to produce inflected verb forms according to time context. Semantic narrations are based on imagined stories and according to a given temporal frame. This task includes 2 pictorial sequences per temporal reference. The accuracy of time marking in the semantic narration task is calculated using ratios. The task will be administered directly (24-48 hours) after the last session of the therapy (post-treatment) and 2-4 weeks after the treatment (follow-up) to analyze the maintenance of performance.

  Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up

• Change from time accuracy on a semantic narration task 2 and 4 weeks after the end of the therapy: untreated semantic narrations

  The semantic narration task evaluates subject's ability to produce inflected verb forms according to time context. Semantic narrations are based on imagined stories and according to a given temporal frame. This task includes 2 pictorial sequences per temporal reference. The accuracy of time marking in the semantic narration task is calculated using ratios. The task will be administered directly (24-48 hours) after the last session of the therapy (post-treatment) and 2-4 weeks after the treatment (follow-up) to analyze the maintenance of performance.

  Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up

• Change from the score on an inflected verb production task 2 and 4 weeks after the end of the therapy: treated items

  The inflected verb production task evaluates subject's ability to produce an inflected verb form according to time context given by a short sentence. The score is obtained by adding the points (0 or 1) obtained for each item and is calculated per time reference. The task will be administered three times before the therapy (baselines) and 2-4 weeks after the treatment (follow-up) to analyze the long-term change of performance.

  Baselines, 2-4 weeks follow-up

• Change from the score on an inflected verb production task 2 and 4 weeks after the end of the therapy: untreated items

  The inflected verb production task evaluates subject's ability to produce an inflected verb form according to time context given by a short sentence. The score is obtained by adding the points (0 or 1) obtained for each item and is calculated per time reference. The task will be administered three times before the therapy (baselines) and 2-4 weeks after the treatment (follow-up) to analyze the long-term change of performance.

  Baselines, 2-4 weeks follow-up

• Change from time accuracy on a semantic narration task 2 and 4 weeks after the end of the therapy: treated semantic narrations

  The semantic narration task evaluates subject's ability to produce inflected verb forms according to time context. Semantic narrations are based on imagined stories and according to a given temporal frame. This task includes 2 pictorial sequences per temporal reference. The accuracy of time marking in the semantic narration task is calculated using ratios. The task will be administered three times before the therapy (baselines) and 2-4 weeks after the treatment (follow-up) to analyze the long-term change of performance.

  Baselines, 2-4 weeks follow-up

• Change from time accuracy on a semantic narration task 2 and 4 weeks after the end of the therapy: untreated semantic narrations

  The semantic narration task evaluates subject's ability to produce inflected verb forms according to time context. Semantic narrations are based on imagined stories and according to a given temporal frame. This task includes 2 pictorial sequences per temporal reference. The accuracy of time marking in the semantic narration task is calculated using ratios. The task will be administered three times before the therapy (baselines) and 2-4 weeks after the treatment (follow-up) to analyze the long-term change of performance.

  Baselines, 2-4 weeks follow-up

Secondary Outcomes (6)

• Change from time accuracy on an episodic/procedural narration task after the end of the therapy

  Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy)

• Change from time accuracy on an episodic/procedural narration task 2 and 4 weeks after the end of the therapy

  Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up

• Change from time accuracy on an episodic/procedural narration task 2 and 4 weeks after the end of the therapy

  Baselines, 2-4 weeks follow-up

• Change at a control task after the end of the therapy

  Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy)

• Change at a control task 2 and 4 weeks after the end of the therapy

  Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up

Study Arms (1)

Brain-injured participants

EXPERIMENTAL

Participants with post-stroke fluent or non-fluent chronic aphasia

Behavioral: Speech and language therapy

Interventions

Speech and language therapy BEHAVIORAL

The treatment focuses on grammatical time marking. The aim of the treatment is to train underlying grammatical time marking processes, which were identified as deficient during a preliminary evaluation. The intervention is composed of 4 steps inspired by models and hypotheses from the literature on the subject. Step 1: "temporal adverbial selection", subject must identify the tense encoded in sentences and select the correct adverbial among those proposed. Step 2: "selection of inflected verb forms", subject must identify the tense encoded in the sentence and select the correct verb form among those proposed. Step 3: "production of inflected verb forms", subject must identify the tense encoded in the sentence and produce inflected verbs. Step 4: "semantic narration", subject must describe scenes using verbs inflected according to the previously defined reference time.

Brain-injured participants

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Neuchatel: lead

Study Sites (1)

Université de Neuchâtel

Neuchâtel, 2000, Switzerland

Location

MeSH Terms

Conditions

Cerebrovascular Trauma; Aphasia; Stroke

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 19, 2022
• Study Start: December 30, 2022
• Primary Completion: April 16, 2024
• Study Completion: April 16, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

CH (1)