Adaptive Trial Scheduling in Naming Treatment for Aphasia

Stroke Clinical Trial

Official title:

Integrating Complementary Learning Principles in Aphasia Rehabilitation Via Adaptive Modeling (Sub-study 2: Adaptive Trial Scheduling)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05653466
• Other study ID #: STUDY21120130 (Study 2)
• Secondary ID: 1R01DC019325-01A
• Status: Recruiting
• Phase: Phase 2
• Start date: December 6, 2023
• Est. completion date: January 31, 2028

Study information

• Verified date: February 2024
• Source: University of Pittsburgh
• Contact: Rickea Hudson-Simpson, B.A.
• Phone: 412-648-3274
• Email: rjh172[@]pitt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: January 31, 2028
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aphasia
• Stroke

Intervention

Behavioral:
• Adaptive Spacing Condition
Each of the 200 target words for practice are presented on a schedule determined by an algorithm that relies on the pattern of correct vs. incorrect responses for each item. Items in the "active learning" state need to be answered correctly a certain number of times before being categorized as "learned." Each item must be answered correctly 3 times in a row (immediately, then at one-minute and five-minute intervals) before it is categorized as "learned." Then, it will be scheduled at ever-increasing intervals, until answered incorrectly, at which point the item would be returned to the "active learning" state, requiring three correct responses in a row to return again to the "learned" expanding interval state.
• High-Item Non-Adaptive Spacing Condition
Each of the 200 target words for practice are presented in sequential order randomized within blocks, with each word presented once before the list repeats.
• Low-Item Non-Adaptive Spacing Condition
Each of the 40 target words for practice are presented in sequential order randomized within blocks, with each word presented once before the list repeats.

Locations

Country	Name	City	State
United States	Language Rehab and Cognition Lab, Department of Communication Sciences and Disorders, School of Health and Rehabilitation Sciences, University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Deafness and Other Communication Disorders (NIDCD), University of Massachusetts, Amherst

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in correct responses in Confrontation Naming of Treated and Untreated Pictured Objects	Confrontation naming accuracy pictures targeted for each training condition and corresponding untreated items will serve as a primary outcome. Individualized lists for each participant will be selected from a corpus of pictured objects. Performance will be evaluated twice at each timepoint. Change in performance from initial assessment to the 3-month follow-up timepoint on the treated and untreated items will serve as the primary outcome measure.	Initial assessment (pre-treatment), 3 months post-treatment
Primary	Change in correct responses in Context Generalization of Treated and Untreated Pictured Objects	Production of trained words on the context generalization complex scene description task for each training condition and corresponding untreated items will serve as a primary outcome. Words from complex scenes and wordless picture books will be chosen for each participant. These words will consist of a subset of those selected for confrontation naming. Performance will be evaluated twice at each timepoint. Change in performance from initial assessment to the 3-month follow-up timepoint on the treated and untreated items will serve as the primary outcome measure.	Initial assessment (pre-treatment), 3 months post-treatment
Secondary	Mean score on the Comprehensive Aphasia Test (CAT)	The Comprehensive Aphasia Test (CAT) is a comprehensive aphasia test battery that assesses language function in the following modalities: Comprehension of Spoken Language, Comprehension of Written Language, Repetition, Naming, Reading, and Writing. The CAT will be used for initial eligibility criteria at baseline. Raw scores for each subtest are converted to T-scores (M = 50; SD = 10) based upon 266 administrations to a normative sample of 113 person with aphasia. A modality mean T-score derived from the eight modalities in the language battery is used to estimate the overall severity of aphasic language impairment. The CAT will be used to confirm a diagnosis of aphasia and determine initial eligibility criteria: participants with CAT mean modality T scores <40 will be excluded from this trial due to the severity of their deficits, as we have found this to be an appropriate cutoff for very severe aphasia in previous trials.	Initial assessment (pre-treatment)
Secondary	S-weight and P-weight scores on the Philadelphia Naming Test (PNT)	The PNT is a confrontation naming test composed of 175 high, middle, and low frequency nouns ranging from 1-4 syllables in length. Items are presented in a random order on a computer monitor and participants are asked to respond with a single word. Responses are recorded and scored offline using standardized procedures for determining accuracy of the first complete attempt and coding of errors. S-weight and P-weight are calculated based on PNT scoring. S-weight can be interpreted as a measure of semantic ability including conceptual access and control and lexical semantics. P-weight is a measure of phonological ability including both lexical and post-lexical phonological access.	Initial assessment (pre-treatment)
Secondary	Score on the Temple Assessment of Language and Short-term Memory in Aphasia (TALSA)	The TALSA is a diagnostic test battery that assesses the relationship between language and memory in people with aphasia through 16 subtests in three main areas (phonological processing, semantic processing, short-term memory). Raw scores on subtests are converted to T-scores which are used to estimate the overall severity of impairment.	Initial assessment (pre-treatment)
Secondary	Mean score on the Cactus and Camels Test (CCT)	The Cactus and Camel Test is a sub-test of the Cambridge Semantic Battery that consists of 64 items scored for accuracy of response.	Initial assessment (pre-treatment)
Secondary	Change in core lexicon analysis on the Aphasia Bank Discourse Protocol	The Aphasia Bank Discourse Protocol is a brief, but thorough set of language tasks which will characterize participants' language at the discourse level. The protocol requires participants to generate discourse samples within the contexts of free speech, a picture description, a story narrative, and procedural discourse. Change in performance in core lexicon analysis on discourse samples from initial assessment to each post-treatment follow up timepoint will serve as a secondary outcome measure.	Initial assessment (pre-treatment), multiple timepoints up to 6-months post-treatment.
Secondary	Score on the Adapted Intrinsic Motivation Inventory for Aphasia	The adapted intrinsic motivation Inventory for aphasia is a brief instrument comprised of 7 subscales with a total of 45 items intended to characterize intrinsic motivation in people with aphasia. Each item is scored on a scale of 1-7. Higher total score is associated with higher intrinsic motivation.	Initial assessment (pre-treatment)
Secondary	Change in mean scores on the Aphasia Communication Outcome Measure Short-Form	The Aphasia Communication Outcome Measure (ACOM) is a measure of patient-reported "communication functioning," defined as the ability to effectively convey and receive personally relevant messages in natural environments. Results are provided in T scores (sample mean of 50 with a standard deviations of 10), with higher scores indicating better communication functioning.	Initial assessment (pre-treatment), 1 week post-treatment.