Multimodal Treatment of Phonological Alexia: Behavioral & fMRI Outcomes

Stroke Clinical Trial

Official title:

Multimodal Treatment of Phonological Alexia: Behavioral & fMRI Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00827268
• Other study ID #: B6699-W
• Status: Completed
• Phase: N/A
• First received: January 20, 2009
• Last updated: November 28, 2017
• Start date: June 2009
• Est. completion date: July 2012

Study information

• Verified date: November 2017
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: July 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Dyslexia
• Dyslexia, Acquired
• Stroke

Intervention

Behavioral:
• One-on-one treatment of reading difficulties
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.

Locations

Country	Name	City	State
United States	North Florida/South Georgia Veterans Health System	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Real World Reading Skills	Real World Reading Skills was tested using the Woodcock Reading Mastery Test-Revised	Language testing are conducted two weeks prior to treatment, immediately following end of treatment and 3 months after end of treatment.

External Links

•   Dr. Conway's homepage