Analysis of Brain Activity to Uncover Brain-behavior Relationships Related to Therapy Outcomes in Aphasia

Aphasia is a loss of language due to stroke or other brain injury. Word-finding in conversation is a universal and persistent difficulty in aphasia. While several techniques exist to improve word-finding in aphasia, it is unclear how the brain changes in response to behavioral therapy. In this study, persons with aphasia will receive behavioral therapy aimed at helping them to be more successful at finding words. Twenty therapy sessions will be provided in a 10-week period. Each therapy session will last about 2 hours and will include a variety of language tasks. Prior to beginning word-finding therapy, each participant will receive two fMRI scans, spaced 10 weeks apart. After finishing therapy, each participant will receive two additional fMRI scans, spaced 10 weeks apart. For a portion of the MRI scan, participants will complete language tasks. The purpose of these fMRI scans is to measure brain changes that may occur due to successful behavioral therapy. The hypotheses are as follows: First, that the behavioral therapy will improve word-finding as it has been shown to do in the past. Second, that the brain will change in a couple of different ways. It is expected that the network of regions that support word-finding will be more connected and work together more efficiently after therapy. It is also expected that the networks of regions that support other aspects of cognitive function, such as attention and executive function, will also be more connected and work together more efficiently.

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Key information

Conditions

Aphasia Anomia Communication Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hershey Medical Campus

Hershey, Pennsylvania, 17033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of aphasia
Sustained stroke more than 6 months prior to consent
Right-handed
Native speakers of English
Completed at least a high school education
Normal or corrected-to-normal vision and hearing
Provide written informed consent
Participants will be medically stable and at least wheelchair ambulatory at the time of participation with uncompromised use of the left hand

Exclusion criteria

History of degenerative neurological disorders (e.g., Alzheimer's disease), acquired neurological disorders other than aphasia from stroke (e.g., traumatic brain injury), developmental neurological disorders (e.g., autism), or psychiatric disorders
An active medical condition that could compromise participation (e.g., cancer undergoing acute treatment)
Not safe to enter the bore of the magnet (e.g., pacemaker)
Taking medications that are known to exert significant effects on cognitive processes
Pregnancy or possibility of pregnancy
Do not meet the above inclusionary criteria

Treatment and study plan

Abstract Semantic Association Network Training (AbSANT)

Behavioral

In each session, the participant will be asked to categorize words, choose/discuss semantic features for each word that accurately describe the word, and generate as many words as possible within a category.

Other names: Semantic word-finding therapy, Semantic Feature Analysis/Verification

Primary outcomes

Therapy Effect Size: Change in word generation performance from pre- to post-treatment measured using a version of Cohen's d

Time frame: At baseline and at approximately 10 weeks (i.e., the end of therapy)

The mean of the baseline scores is subtracted from the mean of the post-treatment scores, and then divided by the standard deviation (SD) of the baseline scores. 6.5-8 is considered a small effect size, 8-9.5 is medium, and above 9.5 is large.
Change in fMRI activation patters from pre- to post-treatment

Time frame: At baseline and at approximately 10 weeks (i.e., the end of therapy)

Blood-oxygen-level-dependent MRI signal measured during task and rest and subjected to statistical tests of significant change from pre- to post-treatment.

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Official study title

Application of Graph Theory to Both Resting-state and Task-based fMRI Data to Uncover Brain-behavior Relationships Related to Therapy Outcomes in Aphasia

Important dates

Study start: 2018
Primary completion: 2023
Study completion: 2023
First posted: Jun 8, 2018
Registry last updated: Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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