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

Primary Purpose

Aphasia

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Abstract Semantic Association Network Training (AbSANT)
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Aphasia focused on measuring aphasia, treatment, therapy, anomia, fMRI, neuroimaging, semantics

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hershey Medical Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aphasia

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 11, 2018
Last Updated
September 19, 2023
Sponsor
Penn State University
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1. Study Identification

Unique Protocol Identification Number
NCT03550092
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 25, 2018 (Actual)
Primary Completion Date
September 1, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia
Keywords
aphasia, treatment, therapy, anomia, fMRI, neuroimaging, semantics

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aphasia
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Abstract Semantic Association Network Training (AbSANT)
Other Intervention Name(s)
Semantic word-finding therapy, Semantic Feature Analysis/Verification
Intervention Description
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.
Primary Outcome Measure Information:
Title
Therapy Effect Size: Change in word generation performance from pre- to post-treatment measured using a version of Cohen's d
Description
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.
Time Frame
At baseline and at approximately 10 weeks (i.e., the end of therapy)
Title
Change in fMRI activation patters from pre- to post-treatment
Description
Blood-oxygen-level-dependent MRI signal measured during task and rest and subjected to statistical tests of significant change from pre- to post-treatment.
Time Frame
At baseline and at approximately 10 weeks (i.e., the end of therapy)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chaleece W Sandberg, Ph.D.
Organizational Affiliation
The Pennsylvania State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hershey Medical Campus
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

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

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