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Clinical Trials/NCT07739875
NCT07739875RecruitingNot Applicable

Word Retrieval in the Wild: Establishing Preliminary Efficacy of Semantic Feature Ecological Momentary Intervention for Post-Stroke Aphasia

Northeastern University1 site in 1 country24 target enrollmentStarted: May 19, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
24
Locations
1
Primary Endpoint
Accuracy on Trained Items

Study Overview

Brief Summary

Anomia (i.e., impaired word retrieval) is one of the most common and debilitating deficits experienced by stroke survivors with aphasia, an acquired disorder characterized by impaired language. Although many anomia treatments exist, treatment response is modest and inconsistent across studies, and the extent of generalization to everyday contexts-the therapy gold standard-is largely unknown. The critical gap between actual outcomes and the therapeutic potential of naming therapy is tied to problems with current treatment delivery practices (i.e., low/unknown dosage, massed practice delivery, and decontextualized training). In this research, we aim to demonstrate that a novel smartwatch-based ecological momentary intervention (EMI) that delivers high-dosage semantic feature training throughout daily life has the potential for overcoming these issues. Every day for six weeks, 20 PWA will complete 24 trials of semantic feature EMI distributed over the day (from 10am-8pm) and delivered by a smartwatch. The EMI trial flow will include five steps: 1) a prompt alert and audiovisual "Ready to name a picture?" cue, 2) a first naming attempt after a YES response, 3) the repetition of an auditory model, 4) semantic feature verification via yes/no questions, and 5) a second naming attempt. To contextualize training further, trained items will be clustered into location categories (e.g., home, pharmacy), and we will use the mobile device's location detection to match PWA's location and item category for ~50% of trials. In Aim #1, we will establish preliminary efficacy of this EMI by determining the extent to which semantic feature EMI improves naming of trained items and generalizes to untrained, related contexts. We predict that the EMI will significantly improve 1) naming of trained items and semantically related, untrained items relative to semantically unrelated items and 2) subjective and objective measures of functional communication effectiveness. Given the novelty of our EMI, the second two aims will focus on identifying key factors of semantic feature EMI user experience (Aim #2) and trends between therapy response and the treatment delivery factors of dosage, trial spacing, and item-location congruence (Aim #3). The proposed research is innovative because of the novel use of EMI for aphasia, our combined application of distributed practice and context-dependent training, and the future promise of extending our system to other types of evidence-based treatment and to other clinical populations, as well as to in-situ "just-in-time" interventions that can intervene in real time during the moment of communication breakdown. The significance of this research lies in its ability to provide technology that automatically tracks dosage metrics; its potential for increasing knowledge regarding which therapy delivery factors impact outcomes; and its promise for providing PWA alternative paths to receive therapy. Successful completion of this research will lead to an R01 application aimed at establishing the efficacy of this novel therapy compared to gold-standard, clinician-provided treatment and determining which active treatment ingredients contribute to outcomes.

Detailed Description

Anomia (i.e., impaired word retrieval) is one of the most common and debilitating deficits experienced by stroke survivors with aphasia, an acquired language disorder. Although many anomia treatments exist, treatment response is modest and inconsistent across studies, and the extent of generalization to everyday contexts-the ultimate goal of therapy-is largely unknown.

The critical gap between actual patient outcomes and the therapeutic potential of naming therapy is tied to treatment delivery limitations. Clinician-provided therapy requires hours of face time between a provider and patient, which limits the total dosage of therapy that can be delivered. Substantial evidence from cognitive psychology and emerging support from aphasia indicates distributed practice is best for long-term retention of treatment gains, yet standard aphasia therapy does not follow this model. Skill transference benefits from context, but most aphasia treatment remains decontextualized, with people with aphasia (PWA) completing sessions in clinic rooms outside of the real-world settings in which they live and communicate. In the current U.S. healthcare system, high-dosage, distributed and contextualized anomia treatment is infeasible.

In ecological momentary intervention (EMI), therapy is provided repeatedly throughout the day over time via prompts from a mobile device. Thus, EMI has inherent capacity for providing high-dosage, distributed, and contextualized therapy, but it is unused in stroke thus far. Research in PWA in EMI's sister method, ecological momentary assessment, does exist, including work by our team. In our work, 14 PWA and 14 controls completed a three-week smartwatch audio-based protocol in which they overtly named prompted pictures while going about daily life. We established feasibility of this method, including finding similar protocol compliance between PWA (77% response rate), controls (78%), and the extant EMA literature (79%). The objective of this phase 1 trial is to test a novel EMI based on our smartwatch naming protocol and semantic feature analysis therapy but with therapy trials temporally distributed throughout everyday life. We selected semantic feature analysis because it is one of the most effective and widely used anomia therapies, and it can be incorporated into our EMI system.

Twenty PWA will complete six weeks of EMI in their community. The EMI trial flow will include five steps: 1) a prompt alert and "Ready to name a picture?" cue, 2) a first naming attempt after a YES response, 3) the repetition of an auditory model, 4) semantic feature verification questions, and 5) a second naming attempt. To test the effects of contextualized training, trained items will be clustered into location categories (e.g., home, pharmacy), and we will use the smartwatch's location detection to match PWA's location and item category for ~50% of trials. All PWA will be scheduled to receive the same number of prompts (i.e., treatment trials) but typical variability in EMI compliance will induce natural variation between PWA in other treatment delivery factors (i.e., total dosage and trial spacing). With this paradigm, we will pursue the following aims:

Aim #1: Determine the extent to which semantic feature EMI improves naming of trained items and generalizes to untrained, related contexts. EMI efficacy will be determined by measuring a) change in trained item accuracy and b) generalization to untrained, semantically related items and functional communication. Consistent with spreading activation theory, we expect EMI to improve naming of trained items and untrained, semantically related items and result in modest (but significant) gains in functional communication.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 89 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Current/pre-stroke English proficiency
  • Normal/corrected-to-normal vision and hearing
  • Medical stability
  • History of left hemisphere stroke at least six months prior to enrollment.
  • Upon enrollment, additional testing will be required to determine eligibility for receiving the therapy, including 1) presence of aphasia as determined by scores on language tests and the study team's clinical judgment (spearheaded by PI Meier) and 2) at least 48 items eligible for training based on the baseline naming probe, a necessity to ensure PWA who do not require training on the targeted word list are not unnecessarily included in the treatment group.

Exclusion Criteria

  • Diagnosis of neurological disease affecting the brain (besides stroke)
  • Major psychiatric disorders
  • Recent history of falls within six months of enrollment

Outcomes

Primary Outcomes

Accuracy on Trained Items

Time Frame: 7 weeks (from before the intervention to the one-week follow-up)

Each participant will receive semantic feature intervention for 24 trained words. Accuracy will be assessed via naming probes administered before, during (at the end of each week), and after therapy. Accuracy will be coded as 0 for incorrect and 1 for correct on each naming probe. Improvement in accuracy on trained items will be compared to change over time on a set of 24 untrained words that are not semantically related to the trained items.

Secondary Outcomes

  • Accuracy on Semantically Related, Untrained Items(7 weeks (from before the intervention to the one-week follow-up))
  • Change in Functional Communication(7 weeks (from before the intervention to the one-week follow-up))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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