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Multimodal Treatment of Phonological Alexia: Behavioral & fMRI Outcomes

Primary Purpose

Aphasia, Stroke, Dyslexia, Acquired

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
One-on-one treatment of reading difficulties
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia focused on measuring Dyslexia, Reading, Aphasia, Stroke

Eligibility Criteria

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

Inclusion Criteria:

  • Adults with post-stroke reading difficulties (phonological alexia)
  • >3 months post-stroke
  • native English speaker
  • can go in MRI scanner (3 to 6 scans),
  • participate in 90 to 120 free treatment sessions
  • return for 3-month post-treatment follow-up assessment & MRI.

Exclusion Criteria:

  • mental illness
  • degenerative disease, visual or auditory acuity impairment
  • drug abuse
  • English is not first language
  • claustrophobia
  • pregnancy

Sites / Locations

  • North Florida/South Georgia Veterans Health System

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm 1

Arm Description

Repeated probes every 8 hours of treatment (1/week)

Outcomes

Primary Outcome Measures

Change in Real World Reading Skills
Real World Reading Skills was tested using the Woodcock Reading Mastery Test-Revised

Secondary Outcome Measures

Full Information

First Posted
January 20, 2009
Last Updated
November 28, 2017
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00827268
Brief Title
Multimodal Treatment of Phonological Alexia: Behavioral & fMRI Outcomes
Official Title
Multimodal Treatment of Phonological Alexia: Behavioral & fMRI Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study offers 90-120 hours of 1:1 training to improve reading skills in adults who have poor reading skills following a stroke. Specifically, this study is designed to improve skill in sounding out words for reading and spelling. The overall time commitment for participation in this study is approximately 11-30 weeks.
Detailed Description
The proposed study is a mixed-effects (single-subject ABA repeated-probe and small group elements) design with 90-120 hours of a modified multi-modal treatment of alexia replicated across up to 18 adults with post-stroke phonological alexia. The short-term goals of this research proposal includes the following: 1) determine if a modified multimodal treatment of phonological alexia can improve pseudoword reading skills (providing a basis from which training will also treat real word reading skills), 2) determine if a modified multimodal treatment of phonological alexia can improve real word reading skills, 3) determine how brain lesion extent and location relate to participants' response to treatment, and 4) identify relationships between changes in functional brain activity in specified regions of interest and participants' response to treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Stroke, Dyslexia, Acquired
Keywords
Dyslexia, Reading, Aphasia, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a repeated probe design study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Arm Description
Repeated probes every 8 hours of treatment (1/week)
Intervention Type
Behavioral
Intervention Name(s)
One-on-one treatment of reading difficulties
Intervention Description
Multimodal behavioral treatment focused on retraining sound to letter associations and skills in sounding out words when reading. Treatment has been pilot-tested in published papers since 1998.
Primary Outcome Measure Information:
Title
Change in Real World Reading Skills
Description
Real World Reading Skills was tested using the Woodcock Reading Mastery Test-Revised
Time Frame
Language testing are conducted two weeks prior to treatment, immediately following end of treatment and 3 months after end of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults with post-stroke reading difficulties (phonological alexia) >3 months post-stroke native English speaker can go in MRI scanner (3 to 6 scans), participate in 90 to 120 free treatment sessions return for 3-month post-treatment follow-up assessment & MRI. Exclusion Criteria: mental illness degenerative disease, visual or auditory acuity impairment drug abuse English is not first language claustrophobia pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy W. Conway, PhD
Organizational Affiliation
North Florida/South Georgia Veterans Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Florida/South Georgia Veterans Health System
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States

12. IPD Sharing Statement

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Multimodal Treatment of Phonological Alexia: Behavioral & fMRI Outcomes

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