Analysis of Brain Activity to Uncover Brain-behavior Relationships Related to Therapy Outcomes in Aphasia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03550092|
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : December 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|Aphasia||Behavioral: Abstract Semantic Association Network Training (AbSANT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
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
|Contact: Chaleece W Sandberg, Ph.D.||firstname.lastname@example.org|
|United States, Pennsylvania|
|Hershey Medical Campus||Recruiting|
|Hershey, Pennsylvania, United States, 17033|
|Contact: Chaleece W Sandberg, Ph.D. 814-263-2006 email@example.com|
|Principal Investigator:||Chaleece W Sandberg, Ph.D.||The Pennsylvania State University|