NCT07739875

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
May 2026Aug 2027

Study Start

First participant enrolled

May 19, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

July 31, 2026

Status Verified

May 1, 2026

Enrollment Period

1.2 years

First QC Date

July 28, 2026

Last Update Submit

July 28, 2026

Conditions

Keywords

AnomiaSemantic Feature AnalysisEcological Momentary Intervention

Outcome Measures

Primary Outcomes (1)

  • Accuracy on Trained Items

    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.

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

Secondary Outcomes (2)

  • 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)

Study Arms (1)

Semantic Feature Ecological Momentary Intervention

EXPERIMENTAL

Participants will wear a smartwatch every day for 6 weeks. Between 10am and 8pm, prompts will be delivered from the watch that correspond to a semantic feature training trial. This intervention is similar to semantic feature verification treatment but delivered via the watch through the day rather than by a clinician in a single session.

Behavioral: Semantic Feature Ecological Momentary Intervention

Interventions

If answered, each prompt will correspond to a single picture naming training trial. The trial flow will include five steps: (1) an initial vibration/chime prompt and audiovisual "Ready to name a picture?" question, (2) a first naming attempt upon a button YES response to the "Ready?" question, (3) an audiovisual model of the target word, (4) an audiovisual cue of "Get ready to answer some questions!" followed by a series of six yes/no semantic feature questions, and (5) a second and final naming attempt upon a YES response to the audiovisual "Ready to name a picture?" question. If the participant taps NO to any "Ready?" question or ignores the prompt, the trial flow will end, and they will be re-prompted once more 10 minutes later. If they ignore or respond NO to the re-prompt, that trial will be skipped. PWA will have 10 seconds to respond to Steps #2, #3, and #5.

Semantic Feature Ecological Momentary Intervention

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northeastern University

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Anomia

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Erin L Meier, PhD

    Northeastern University

    PRINCIPAL INVESTIGATOR
  • Stephen S. Intille, PhD

    Northeastern University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin L Meier, PhD

CONTACT

The Aphasia Network Lab

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2026

First Posted

July 31, 2026

Study Start

May 19, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

July 31, 2026

Record last verified: 2026-05

Locations