Clinical trial NCT05653466: Adaptive Trial Scheduling in Naming Treatment for Aphasia
Official title: Integrating Complementary Learning Principles in Aphasia Rehabilitation Via Adaptive Modeling (sub-study 2: Adaptive Trial Scheduling)
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: 32
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 2, which will evaluate the benefits of adaptive trial spacing.

Detailed description: Study 2: Evaluate the benefits of adaptive trial scheduling.

Study design: Investigators will enroll 32 people with aphasia in a randomized within-subjects crossover design comparing an adaptive scheduling condition to two non-adaptive conditions. Conditions will be matched for total treatment hours in a synchronous/asynchronous telehealth format designed to approximate real-world clinical practice. Participants will receive 10 weeks of computer-based training per condition, with probes administered at baseline and at 1 week, 3 months, and 6 months post-treatment. Condition order will be randomly assigned and counter-balanced across participants. In total, Study 2 will include two initial assessment sessions, 30 one-on-one treatment sessions, 96 independent practice sessions, and 24 baseline and follow-up probe sessions per participant over a 1-year period. All assessment, treatment, and probe sessions will take place via telehealth.

Treatment description: For each condition, all treatment procedures will be matched except for the number of treated words and the trial spacing manipulation. The treatment phase will consist of two weeks of one-on-one treatment twice per week in which the treating clinician will ensure participants know how to use the treatment web app and complete each step of flashcard practice with complete independence, followed by 8 weeks of combined synchronous/asynchronous telepractice, in which the participant will work with the treating clinician once per week and practice an additional 4 days a week for 30 minutes a day between sessions. To carefully control dosage between treatment conditions, all independent practice sessions will be logged and proctored by a student research assistant. In-person treatment sessions will each last 45 minutes to approximate realistic treatment dosage in outpatient or home health practice settings. Treatment will consist of effortful retrieval practice: on each trial, participants will see a picture of the target and attempt to name it, then press "show answer" to see and hear the target in verbal and written form. They will then rate their naming accuracy by button press. If they are unable to name the word correctly, they will be trained to replay the answer and repeat it 3 times prior to moving on to the next trial, per Conroy et al.

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.
* Must have access to a high-speed internet connection and be able to participate in telehealth.

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: