Clinical trial NCT03550092: Analysis of Brain Activity to Uncover Brain-behavior Relationships Related to Therapy Outcomes in Aphasia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Keywords: aphasia
treatment
therapy
anomia
fMRI
neuroimaging
semantics
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. 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
2. An active medical condition that could compromise participation (e.g., cancer undergoing acute treatment)
3. Not safe to enter the bore of the magnet (e.g., pacemaker)
4. Taking medications that are known to exert significant effects on cognitive processes
5. Pregnancy or possibility of pregnancy
6. Do not meet the above inclusionary criteria

Primary outcomes:
measure: Therapy Effect Size: Change in word generation performance from pre- to post-treatment measured using a version of Cohen's d
timeFrame: At baseline and at approximately 10 weeks (i.e., the end of therapy)
measure: Change in fMRI activation patters from pre- to post-treatment
timeFrame: At baseline and at approximately 10 weeks (i.e., the end of therapy)
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Hershey Medical Campus
state: Pennsylvania
Study officials:
affiliation: The Pennsylvania State University
name: Chaleece W Sandberg, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: