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

NCT03550092 | Completed

• 1 other identifier: 1R21DC016708-01A1
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aphasia

Keywords

aphasia; treatment; therapy; anomia; fMRI; neuroimaging; semantics

Outcome Measures

Primary Outcomes (2)

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

  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.

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

• Change in fMRI activation patters from pre- to post-treatment

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

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

Study Arms (1)

Aphasia

EXPERIMENTAL

Abstract Semantic Association Network Training (AbSANT) Each session will be 2 hours long and will occur twice each week for a total of 20 sessions.

Behavioral: Abstract Semantic Association Network Training (AbSANT)

Interventions

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.

Also known as: Semantic word-finding therapy, Semantic Feature Analysis/Verification

Aphasia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

Hershey Medical Campus

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Aphasia; Anomia

Condition Hierarchy (Ancestors)

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

Study Officials

• Chaleece W Sandberg, Ph.D.

  The Pennsylvania State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: June 8, 2018
• Study Start: September 25, 2018
• Primary Completion: September 1, 2023
• Study Completion: December 31, 2023
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

US (1)