Trial Outcomes & Findings for Determining Learning Ability in People With Aphasia (NCT NCT05119023)

Results Overview

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 \& Schumacher, 2012). A Cohen's d effect size (ES) of observational learning is calculated for each individual participant that compares mean RTs on the final sequenced block (S7) and the pseudorandom block (PS8) using pooled standard deviations. Mean Cohen's d is reported. Negative values indicate better learning.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

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

Results posted on

2025-03-10

Participant Flow

Individuals with aphasia were recruited by referral from physicians, speech-language pathologists, neuropsychologists. Individuals with aphasia were also recruited from the MGH-Institute of Health Professions Aphasia Center. Participants were recruited via word of mouth, flyers/presentations and through Rally at Mass General Brigham, an online portal advertising research studies being carried out within the Mass General Brigham Network. The recruitment period lasted from 5/15/22 - 7/15/23

Participant milestones

Participant milestones
Measure	Characterization of Learning All participants complete behavioral (computer-based) learning tasks that measure their ability to learn observationally (observational learning ability: SRT Observational learning and AGL observational learning) and via rules (rule-based AGL learning ability, \[RB AGL\]). Participants additionally complete standardized cognitive-linguistic tests. Learning tasks and cognitive linguistic tests are completed over the course of 2 to 3 sessions, each lasting around 2 hours each. The AGL Observational task was always completed before the rule-based AGL task. SRT Observational and AGL Observational task order was counterbalanced. Enrolled participants who were safe to scan via magnetic resonance imaging (MRI) completed a structural MRI scan between one-month and five months from behavioral testing of learning.
Characterization of Learning-visits 1&2 STARTED	18
Characterization of Learning-visits 1&2 COMPLETED	14
Characterization of Learning-visits 1&2 NOT COMPLETED	4
Brain Imaging - Session 3 STARTED	8
Brain Imaging - Session 3 COMPLETED	8
Brain Imaging - Session 3 NOT COMPLETED	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Characterization of Learning All participants complete behavioral (computer-based) learning tasks that measure their ability to learn observationally (observational learning ability: SRT Observational learning and AGL observational learning) and via rules (rule-based AGL learning ability, \[RB AGL\]). Participants additionally complete standardized cognitive-linguistic tests. Learning tasks and cognitive linguistic tests are completed over the course of 2 to 3 sessions, each lasting around 2 hours each. The AGL Observational task was always completed before the rule-based AGL task. SRT Observational and AGL Observational task order was counterbalanced. Enrolled participants who were safe to scan via magnetic resonance imaging (MRI) completed a structural MRI scan between one-month and five months from behavioral testing of learning.
Characterization of Learning-visits 1&2 Withdrawal by Subject	1
Characterization of Learning-visits 1&2 Change in health status unrelated to study rendered unable to participate	2
Characterization of Learning-visits 1&2 Lost to Follow-up	1

Baseline Characteristics

Determining Learning Ability in People With Aphasia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Characterization of Learning n=18 Participants All participants are assigned to complete behavioral (computer-based) learning tasks that measure their ability to learn observationally (observational learning ability) and via rules (rule-based learning ability). Observational Learning: All participants will complete a computer-based serial response time task intended to measure observational (implicit) learning ability. In this task, participants look at a dot move from one of 4 positions on a computer screen. Unbeknownst to participants, dot movement followed a 12-movement pattern for most experimental blocks. Eye-tracking data is collected and eye fixations within regions of interest trigger trial advancement. Learning ability is evaluated as a comparison of saccadic response times during sequenced trials relative to pseudorandomized trials. Rule-based Learning: All participants will complete a computer-based rule-based learning task intended to measure rule-based (explicit) learning ability. In this task, participants look at sequences of geometric shapes on a computer screen. Through visuals and verbal instruction, they are taught 5 rules that govern sequences. After learning rules, participants are asked to judge via button press whether novel sequences adhere to rules or not.
Age, Continuous	61.89 Years STANDARD_DEVIATION 10.22 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants
Months post stroke	106 Months STANDARD_DEVIATION 96.2 • n=5 Participants

PRIMARY outcome

Timeframe: 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 \& Schumacher, 2012). A Cohen's d effect size (ES) of observational learning is calculated for each individual participant that compares mean RTs on the final sequenced block (S7) and the pseudorandom block (PS8) using pooled standard deviations. Mean Cohen's d is reported. Negative values indicate better learning.

Outcome measures

Outcome measures
Measure	Characterization of Learning n=14 Participants All participants complete behavioral (computer-based) learning tasks that measure their ability to learn observationally (observational learning ability: SRT Observational learning and AGL observational learning) and via rules (rule-based AGL learning ability, \[RB AGL\]). Participants additionally complete standardized cognitive-linguistic tests. Learning tasks and cognitive linguistic tests are completed over the course of 2 to 3 sessions, each lasting around 2 hours each. The AGL Observational task was always completed before the rule-based AGL task. SRT Observational and AGL Observational task order was counterbalanced. Enrolled participants who were safe to scan via magnetic resonance imaging (MRI) completed a structural MRI scan between one-month and five months from behavioral testing of learning.
SRT Observational Learning Ability	-0.03 Cohen's d Standard Deviation 0.34

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Characterization of Learning n=14 Participants All participants complete behavioral (computer-based) learning tasks that measure their ability to learn observationally (observational learning ability: SRT Observational learning and AGL observational learning) and via rules (rule-based AGL learning ability, \[RB AGL\]). Participants additionally complete standardized cognitive-linguistic tests. Learning tasks and cognitive linguistic tests are completed over the course of 2 to 3 sessions, each lasting around 2 hours each. The AGL Observational task was always completed before the rule-based AGL task. SRT Observational and AGL Observational task order was counterbalanced. Enrolled participants who were safe to scan via magnetic resonance imaging (MRI) completed a structural MRI scan between one-month and five months from behavioral testing of learning.
AGL Observational Learning Ability	50.08 Percent accuracy Standard Deviation 12.19

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Characterization of Learning n=14 Participants All participants complete behavioral (computer-based) learning tasks that measure their ability to learn observationally (observational learning ability: SRT Observational learning and AGL observational learning) and via rules (rule-based AGL learning ability, \[RB AGL\]). Participants additionally complete standardized cognitive-linguistic tests. Learning tasks and cognitive linguistic tests are completed over the course of 2 to 3 sessions, each lasting around 2 hours each. The AGL Observational task was always completed before the rule-based AGL task. SRT Observational and AGL Observational task order was counterbalanced. Enrolled participants who were safe to scan via magnetic resonance imaging (MRI) completed a structural MRI scan between one-month and five months from behavioral testing of learning.
AGL Rule-based Learning Ability	63.1 Percent accuracy Standard Deviation 21.6

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Characterization of Learning n=14 Participants All participants complete behavioral (computer-based) learning tasks that measure their ability to learn observationally (observational learning ability: SRT Observational learning and AGL observational learning) and via rules (rule-based AGL learning ability, \[RB AGL\]). Participants additionally complete standardized cognitive-linguistic tests. Learning tasks and cognitive linguistic tests are completed over the course of 2 to 3 sessions, each lasting around 2 hours each. The AGL Observational task was always completed before the rule-based AGL task. SRT Observational and AGL Observational task order was counterbalanced. Enrolled participants who were safe to scan via magnetic resonance imaging (MRI) completed a structural MRI scan between one-month and five months from behavioral testing of learning.
Standardized Assessment of Cognitive Linguistic Ability - Language Severity	80.5 units on a scale of 100 Standard Deviation 13.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Characterization of Learning n=14 Participants All participants complete behavioral (computer-based) learning tasks that measure their ability to learn observationally (observational learning ability: SRT Observational learning and AGL observational learning) and via rules (rule-based AGL learning ability, \[RB AGL\]). Participants additionally complete standardized cognitive-linguistic tests. Learning tasks and cognitive linguistic tests are completed over the course of 2 to 3 sessions, each lasting around 2 hours each. The AGL Observational task was always completed before the rule-based AGL task. SRT Observational and AGL Observational task order was counterbalanced. Enrolled participants who were safe to scan via magnetic resonance imaging (MRI) completed a structural MRI scan between one-month and five months from behavioral testing of learning.
Standardized Assessment of Cognitive Linguistic Ability - Cognitive Composite : Attention	88.77 percent score Standard Deviation 21.87

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Characterization of Learning n=14 Participants All participants complete behavioral (computer-based) learning tasks that measure their ability to learn observationally (observational learning ability: SRT Observational learning and AGL observational learning) and via rules (rule-based AGL learning ability, \[RB AGL\]). Participants additionally complete standardized cognitive-linguistic tests. Learning tasks and cognitive linguistic tests are completed over the course of 2 to 3 sessions, each lasting around 2 hours each. The AGL Observational task was always completed before the rule-based AGL task. SRT Observational and AGL Observational task order was counterbalanced. Enrolled participants who were safe to scan via magnetic resonance imaging (MRI) completed a structural MRI scan between one-month and five months from behavioral testing of learning.
Standardized Assessment of Cognitive Linguistic Ability - Cognitive Composite : Working Memory	51.06 percent score Standard Deviation 20.67

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Characterization of Learning n=14 Participants All participants complete behavioral (computer-based) learning tasks that measure their ability to learn observationally (observational learning ability: SRT Observational learning and AGL observational learning) and via rules (rule-based AGL learning ability, \[RB AGL\]). Participants additionally complete standardized cognitive-linguistic tests. Learning tasks and cognitive linguistic tests are completed over the course of 2 to 3 sessions, each lasting around 2 hours each. The AGL Observational task was always completed before the rule-based AGL task. SRT Observational and AGL Observational task order was counterbalanced. Enrolled participants who were safe to scan via magnetic resonance imaging (MRI) completed a structural MRI scan between one-month and five months from behavioral testing of learning.
Standardized Assessment of Cognitive Linguistic Ability - Cognitive Composite : Executive Function	75.24 percent score Standard Deviation 17.11

SECONDARY outcome

Timeframe: 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 versus rule-based learning: the prefrontal cortex and the striatum.

Outcome measures

Outcome measures
Measure	Characterization of Learning n=8 Participants All participants complete behavioral (computer-based) learning tasks that measure their ability to learn observationally (observational learning ability: SRT Observational learning and AGL observational learning) and via rules (rule-based AGL learning ability, \[RB AGL\]). Participants additionally complete standardized cognitive-linguistic tests. Learning tasks and cognitive linguistic tests are completed over the course of 2 to 3 sessions, each lasting around 2 hours each. The AGL Observational task was always completed before the rule-based AGL task. SRT Observational and AGL Observational task order was counterbalanced. Enrolled participants who were safe to scan via magnetic resonance imaging (MRI) completed a structural MRI scan between one-month and five months from behavioral testing of learning.
Percent Spared Tissue Per ROI Prefrontal cortex ROI	88.8 Percent Spared Tissue within the ROI Standard Deviation 11.8
Percent Spared Tissue Per ROI Striatum ROI	79.37 Percent Spared Tissue within the ROI Standard Deviation 18.84

Adverse Events

Characterization of Learning

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sofia Vallila Rohter, Project Principle Investigator

MGH-Institute of Health Professions

Phone: 617-724-3824

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place