Clinical trial NCT05653440: Balancing Effortful and Errorless Learning in Naming Treatment for Aphasia
Official title: Integrating Complementary Learning Principles in Aphasia Rehabilitation Via Adaptive Modeling (sub-study 1: Balancing Effortful and Errorless Learning Via Adaptive Naming Deadlines)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Aphasia
Stroke
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Amherst
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2022-12-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Aphasia is a language disorder caused by stroke and other acquired brain injuries that affects over two million people in the United States and which interferes with life participation and quality of life. Anomia (i.e., word- finding difficulty) is a primary frustration for people with aphasia. Picture-based naming treatments for anomia are widely used in aphasia rehabilitation, but current treatment approaches do not address the long-term retention of naming abilities and do not focus on using these naming abilities in daily life. The current research aims to evaluate novel anomia treatment approaches to improve long-term retention and generalization to everyday life.

This study is one of two that are part of a larger grant. This record is for sub-study 1, which will adaptively balance effort and accuracy using speeded naming deadlines.

Detailed description: Study 1: Evaluate the benefits of balancing effortful and errorless learning via adaptive naming deadlines.

* Study design: The investigators will enroll 30 people with aphasia in a randomized within-subjects crossover design comparing trained words in three retrieval conditions. Stimuli will be balanced across conditions using an established item-response theory algorithm developed by Dr. Hula (consultant). Participants will receive 8 sessions of treatment per condition (2x/ week for 4 weeks), with probes administered at baseline and 1 week, 3 months, and 6 months post-treatment. Condition treatment order will be randomly assigned and counter- balanced across participants. In total, Sub-study 1 includes two initial assessment sessions, 24 treatment sessions and 24 baseline and follow-up probe assessment sessions per participant over a 10-month period. Data collection will take place at the Language Rehabilitation and Cognition Laboratory (LRCL) at the University of Pittsburgh, in participants' homes, or in private rooms in public spaces (e.g. libraries, community centers).
* Participants: The investigators will recruit 30 male and female community-dwelling people with aphasia \>6 months post- onset of aphasia due to unilateral left-hemisphere stroke. Aphasia diagnosis will be confirmed by Comprehensive Aphasia Test (CAT) performance and medical history. Investigators will exclude potential participants with right hemisphere stroke, other neurological disease, significant psychiatric disorder, severe motor speech disorder, or active substance dependence.
* Assessment Procedures: Participants will be tested on a comprehensive initial battery of standardized assessments characterizing their aphasia severity and overall language profile, naming and discourse abilities, semantic processing, verbal short-term and working memory at baseline. Patient-reported measures of treatment motivation and pre-post changes in communication effectiveness will also be measured in response to each treatment condition. These tests will ensure that our participants well-characterized from a behavioral perspective, and measures will be used in secondary analyses and model development exploring predictors of treatment response.
* Treatment description: Each training trial will consist of a fixation cross and picture presentation. A repetition cue (audio recording and written from of the target) will be provided to participants based on the deadlines described above. Participants will be instructed to name the picture and indicate when they have given their final answer via key press, with responses also timed and scored by clinician key press. In the errorless condition, they will be instructed to repeat the target, while in the other conditions they will be asked to try to name the picture independently before they hear the target. Once they have indicated that they have provided their final answer, they will receive accuracy feedback on the computer screen based on clinician scoring. To maximize the clinical relevance of this study, investigators will control total amount of treatment time (8 hours) between conditions, instead of controlling the total number of trials. This is because many more trials can be completed per hour in the errorless or balanced conditions compared to the effort-maximized condition, and investigators want study outcomes to practically inform clinicians on how best to spend limited treatment time.

Eligibility criteria: Inclusion Criteria:

* Existing diagnosis of chronic (\>6 months) aphasia subsequent to left hemisphere stroke.
* Impaired performance on 2/8 sections of the Comprehensive Aphasia Test.

Exclusion Criteria:

* History of other acquired or progressive neurological disease.
* Significant language comprehension impairments (per performance on the CAT - individuals will be excluded if their spoken language comprehension mean modality T- score on the CAT falls below 40).
* Unmanaged drug / alcohol dependence.
* Severe diagnosed mood or behavioral disorders that require specialize mental health interventions.

Primary outcomes:
measure: Change in correct responses in Confrontation Naming of Treated and Untreated Pictured Objects
timeFrame: Initial assessment (pre-treatment), 3 months post-treatment
measure: Change in correct responses in Context Generalization of Treated and Untreated Pictured Objects
timeFrame: Initial assessment (pre-treatment), 3 months post-treatment
Secondary outcomes:
measure: Mean score on the Comprehensive Aphasia Test (CAT)
timeFrame: Initial assessment (pre-treatment)
measure: S-weight and P-weight scores on the Philadelphia Naming Test (PNT)
timeFrame: Initial assessment (pre-treatment)
measure: Score on the Temple Assessment of Language and Short-term Memory in Aphasia (TALSA)
timeFrame: Initial assessment (pre-treatment)
measure: Mean score on the Cactus and Camels Test (CCT)
timeFrame: Initial assessment (pre-treatment)
measure: Change in core lexicon analysis on the Aphasia Bank Discourse Protocol
timeFrame: Initial assessment (pre-treatment), multiple timepoints up to 6-months post-treatment.
measure: Score on the Adapted Intrinsic Motivation Inventory for Aphasia
timeFrame: Initial assessment (pre-treatment)
measure: Change in mean scores on the Aphasia Communication Outcome Measure Short-Form
timeFrame: Initial assessment (pre-treatment), 1 week post-treatment.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Language Rehab and Cognition Lab, Department of Communication Sciences and Disorders, School of Health and Rehabilitation Sciences, University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: William Evans, PhD
role: PRINCIPAL_INVESTIGATOR
References: