Word Retrieval in the Wild in People With Post-Stroke Aphasia

NCT05338216 | Completed Results

• 1 other identifier: UL1TR002544
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

People with post-stroke aphasia (PWA) suffer from anomia, a condition where they know what they want to say but cannot retrieve the words. For PWA, word retrieval changes moment-to-moment, leading to diminished motivation to participate in conversations and disengagement from social interactions. In the real world, anomia variability and severity are compounded by contextual factors of communication exchanges (noise, dual-tasking). Ecological momentary assessment (EMA) involves in-situ measurement of a behavior over time during everyday life. EMA has promise for capturing real-world anomia, yet EMA methods have not been tested in PWA. Therefore, the aims of this pilot study are to (1) determine the relative feasibility of two types of smartwatch-delivered EMA (traditional-EMA and micro-EMA) in PWA and (2) determine the extent to which patient-specific factors relate to feasibility. Twenty PWA will be recruited and randomly assigned to either traditional-EMA or micro-EMA conditions. To target in-situ anomia, PWA will complete 36 picture-naming trials/day for three weeks, delivered either as a single trial 36 times per day (micro-EMA) or in four sets of nine trials/set per day (traditional-EMA). Due to the "at-a-glance" single trial delivery of micro-EMA, the investigators hypothesize that PWA in the micro-EMA condition will demonstrate better protocol adherence than PWA in the traditional-EMA condition. Older age, more severe cognitive-linguistic deficits, and greater discomfort with technology will be related to poorer compliance, lower completion, greater perceived burden, and lower intelligibility of naming audio recordings. This bench-to-bedside research will begin a translational path to implement EMA/micro-EMA into routine assessment of aphasia.

Conditions

Aphasia, Acquired

Keywords

Aphasia; Stroke; Ecological Momentary Assessment; Experience Sampling

Outcome Measures

Primary Outcomes (3)

• Change in Protocol Compliance

  Compliance will be determined by considering the total number of YES button responses to the "Ready?" screen over the total number of scheduled prompts. This measure will include trials that are missed due to the watch being uncharged or turned off, an important aspect of protocol adherence.

  Every day over the three-week at-home smartwatch naming protocol

• Change in Protocol Completion

  Completion will reflect participants' ability to adhere to each step of the smartwatch prompt, including pressing the YES button to the "Ready?", looking at the pictured object(s), and attempting to name the picture(s) aloud. Completion will be determined by considering the total number of naming attempts (indexed by the number of trials for which the participants' voice is audible on the audio recording, disregarding intelligibility of the response) over the total number of prompts delivered to the watch; this measure will exclude trials that are missed due to the watch being uncharged or off.

  Every day over the three-week at-home smartwatch naming protocol

• Change in Audio Intelligibility

  An objective measure of speech intelligibility of audio recordings will be obtained by SLP graduate student RAs manually coding each picture naming audio clip. While the task is a single-word naming task, PWA often produce more than one word in their attempt to name a picture (e.g., "uh asparagus no um green…um bean!" to a picture of bean). It is possible that only part of a multi-word response will be intelligible. Audio clips will be coded as being either completely intelligible (1) or partially/completely unintelligible (0). For each participant, the percentage of intelligible responses will be calculated using the following formula: (\[sum of intelligible responses\] / \[sum of all responses\])\*100.

  Every day over the three-week at-home smartwatch naming protocol

Secondary Outcomes (1)

• Change in Perceived Burden

  Once per week over the three-week at-home smartwatch naming protocol

Study Arms (2)

Traditional Ecological Momentary Assessment (Traditional EMA)

EXPERIMENTAL

People with aphasia (PWA) in the traditional EMA arm will receive four prompts per day to complete a set of nine picture naming trials per prompt for a total of n = 36 prompts/day for three weeks.

Behavioral: Traditional EMA

Micro-Interaction Ecological Momentary Assessment (µEMA)

EXPERIMENTAL

People with aphasia (PWA) in the µEMA condition will complete a single naming trial at a time, 36 times per day for three weeks.

Behavioral: Micro-Interaction EMA

Interventions

Traditional EMA BEHAVIORAL

Participants will wear a smartwatch for three weeks. Throughout the day (10am-8pm), the watch will vibrate and a written alert will appear on the screen asking participants if they are ready to name some/a picture(s). Once the picture appears, the participant will attempt to name the picture aloud while the watch records audio. The participants will have up to five seconds to name the picture before a "Thank You!" screen appears. In this arm, participants will name 9 pictures back-to-back four times/day.

Traditional Ecological Momentary Assessment (Traditional EMA)

Micro-Interaction EMA BEHAVIORAL

Participants will wear a smartwatch for three weeks. Throughout the day (10am-8pm), the watch will vibrate and a written alert will appear on the screen asking participants if they are ready to name some/a picture(s). Once the picture appears, the participant will attempt to name the picture aloud while the watch records audio. The participants will have up to five seconds to name the picture before a "Thank You!" screen appears. In this arm, participants will name one picture at a time, 36 times/day.

Micro-Interaction Ecological Momentary Assessment (µEMA)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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, and
• Presence of aphasia

You may not qualify if:

• History of neurological disease affecting the brain other than stroke

Sponsors & Collaborators

• Northeastern University: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Northeastern University

Boston, Massachusetts, 02115, United States

Location

Related Publications (19)

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  PMID: 38549687 RESULT

MeSH Terms

Conditions

Aphasia; Stroke

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

The main limitation of this pilot study was the small number of participants. Note that this study evaluated the utility of assessments, not an intervention.

Results Point of Contact

• Title: Dr. Erin Meier
• Organization: Northeastern University

e.meier@northeastern.edu

1 (617) 373-7438

Study Officials

• Erin L Meier, PhD

  Northeastern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will not be told explicitly that there are two arms or which arm they are in.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Twenty PWA will participate in this pilot study, randomly assigned to the µEMA condition (n = 10) or traditional EMA condition (n = 10). In both the µEMA and traditional EMA protocols, the smartwatch will vibrate to alert the participant to a prompt to complete either a single picture naming trial (in the µEMA condition) or a set of picture naming trials (in the traditional EMA condition). The only difference between conditions will be the trial delivery schedule: PWA in the µEMA condition will complete a single naming trial at a time, 36 times per day whereas PWA in the traditional EMA condition will receive four prompts per day to complete a set of nine picture naming trials per prompt.

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: April 21, 2022
• Study Start: December 19, 2022
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: July 8, 2025
• Results First Posted: July 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The data will be available in April 2024.
• Access Criteria: The data will be available either by contacting the first author on respective publications and/or through a data-sharing platform (e.g., OSF).

Locations

US (1)