NCT05119023

Determining Learning Ability in People With Aphasia

Completed NA Results posted Last updated 10 March 2025

What this trial tests

NA trial testing SRT Observational Learning in Aphasia in 18 participants. Completed in 1 September 2023.

Timeline

6 June 2022

Primary endpoint
1 September 2023

1 September 2023

Quick facts

Lead sponsor	MGH Institute of Health Professions
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	18
Start date	6 June 2022
Primary completion	1 September 2023
Estimated completion	1 September 2023
Sites	1 location across United States

Drugs / interventions tested

• SRT Observational Learning
• AGL Observational Learning
• AGL Rule-based Learning
• Standardized cognitive-linguistic assessment
• Brain imaging

Conditions studied

• Aphasia — all drugs for Aphasia →

Sponsor

MGH Institute of Health Professions

Who can join

Adults 18 to 80, any sex, with Aphasia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

SRT Observational Learning Ability Primary · Study visit 1 or 2, AGL Observational task completed before rule-based AGL task. SRT Observational and AGL Observational task order counterbalanced

For the SRT observational learning task, responses are made via eye gaze into a visual area of interest (AOI). Reaction times (RTs) are recorded as the time between target onset and gaze fixation within the target AOI. A trial is considered incorrect if an eye fixation was made that does not correspond to the target AOI. RTs for correct trials are examined. Outlier RTs three standard deviations above the mean RT of each block are removed. A score of learning is computed by comparing RTs on the last (7th) sequenced block of trials with RTs on the following (8th) pseudorandomized block (Schwarb

Group	Value	95% CI
Characterization of Learning	-0.03	± 0.34

AGL Observational Learning Ability Primary · Study visit 1 or 2, AGL Observational task completed before rule-based AGL task. SRT Observational and AGL Observational task order counterbalanced

For the AGL Observational learning task, a percent accuracy score is computed for the test phase. Higher scores indicate better outcome.

Group	Value	95% CI
Characterization of Learning	50.08	± 12.19

AGL Rule-based Learning Ability Primary · Study visit 1 or 2, AGL Observational task completed before rule-based AGL task. SRT Observational and AGL Observational task order counterbalanced

For the rule-based AGL task, a percent accuracy score is computed for the test phase. Higher scores indicate better outcome.

Group	Value	95% CI
Characterization of Learning	63.1	± 21.6

Standardized Assessment of Cognitive Linguistic Ability - Language Severity Secondary · Study visit 1 or 2

Standardized measure of severity of expressive and receptive language deficits (Western Aphasia Battery \[WAB\] score range 0 - 100 with high scores indicating lower severity)

Group	Value	95% CI
Characterization of Learning	80.5	± 13.8

Standardized Assessment of Cognitive Linguistic Ability - Cognitive Composite : Attention Secondary · Study visit 1 or 2

Composite scores based on standardized assessments of attention, working memory, and executive function were computed. Each score is computed and reported as an percent score. Minimum score is 0, maximum is 100. Higher scores indicate better cognitive ability.

Group	Value	95% CI
Characterization of Learning	88.77	± 21.87

Standardized Assessment of Cognitive Linguistic Ability - Cognitive Composite : Working Memory Secondary · Study visit 1 or 2

Composite scores based on standardized assessments of attention, working memory, and executive function were computed. Each score is computed and reported as an percent score. Minimum score is 0, maximum is 100. Higher scores indicate better cognitive ability.

Group	Value	95% CI
Characterization of Learning	51.06	± 20.67

Standardized Assessment of Cognitive Linguistic Ability - Cognitive Composite : Executive Function Secondary · Study visit 1 or 2

Composite scores based on standardized assessments of attention, working memory, and executive function were computed. Each score is computed and reported as an percent score. Minimum score is 0, maximum is 100. Higher scores indicate better cognitive ability.

Group	Value	95% CI
Characterization of Learning	75.24	± 17.11

Percent Spared Tissue Per ROI Secondary · Study visit 3, between one-month and five months from behavioral testing of learning

Lesion maps, in which the lesioned voxels are assigned a binary value (1 or 0), are normalized from native to the Montreal Neurological Institute (MNI) template (a standard brain template utilized in imaging studies). Individualized lesion maps are subtracted from each brain region of interest (ROI) to yield the volume of spared tissue per ROI. The percentage of spared tissue in each region is calculated by dividing the volume of spared tissue by the total volume of the MNI template atlas ROI. Two ROIs have been selected based on prior research showing differential activation in observational

Prefrontal cortex ROI

Group	Value	95% CI
Characterization of Learning	88.8	± 11.8

Striatum ROI

Group	Value	95% CI
Characterization of Learning	79.37	± 18.84

Sponsor's own description

Aphasia is an impairment in the expression or comprehension of language that results from stroke, traumatic brain injury or progressive neurological disease. Approximately two million people in the United States suffer from aphasia, which has profound impacts on quality of life, the ability to return to work and participation in life activities. Research has shown that speech-language therapy, the treatment for aphasia, can significantly improve people's ability to communicate. However, a major limitation in the field of aphasia rehabilitation is the lack of predictability in patients' response to therapy and the inability to tailor treatment to individuals. Currently, aphasia treatments are selected largely based on patient's language abilities and language deficits with little consideration of learning ability, which this study refers to as learning phenotype. Learning phenotype has been used to inform rehabilitation approaches in other domains but is not currently considered in aphasia. The overarching hypothesis of this work is that poor alignment of learning ability and language therapy limits progress for patients and presents a barrier to individualizing treatment.

The objectives of the proposed study are to (1) determine the learning phenotype of individuals with aphasia, and (2) examine how lesion characteristics (size and location of damage to the brain), language ability and cognitive ability relate to learning ability. To accomplish objectives, investigators propose to measure implicit (observational) and explicit (rule-based) learning ability in people with aphasia via computer-based tasks. Regression models will be used to examine brain and behavioral factors that relate to learning ability.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.