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

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ClinicalTrials.gov Identifier: NCT03550092
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Chaleece Sandberg, Penn State University

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) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 25, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

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




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03550092


Contacts
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Contact: Chaleece W Sandberg, Ph.D. 8148632006 cws18@psu.edu

Locations
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United States, Pennsylvania
Hershey Medical Campus Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Chaleece W Sandberg, Ph.D.    814-263-2006    cws18@psu.edu   
Sponsors and Collaborators
Penn State University
Investigators
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Principal Investigator: Chaleece W Sandberg, Ph.D. The Pennsylvania State University
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Responsible Party: Chaleece Sandberg, Assistant Professor, Penn State University
ClinicalTrials.gov Identifier: NCT03550092    
Other Study ID Numbers: 1R21DC016708-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chaleece Sandberg, Penn State University:
aphasia
treatment
therapy
anomia
fMRI
neuroimaging
semantics
Additional relevant MeSH terms:
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Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases