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

Sponsor

Penn State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03550092

Collaborator

(none)

Enrollment

Location

Arm

56.2

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aphasia	Behavioral: Abstract Semantic Association Network Training (AbSANT)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official 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

Actual Study Start Date :

Sep 25, 2018

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aphasia 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) 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

Arm

Intervention/Treatment

Experimental: Aphasia

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)

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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