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Multimodal Treatment of Phonological Alexia: Behavioral & fMRI Outcomes

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ClinicalTrials.gov Identifier: NCT00827268
Recruitment Status : Completed
First Posted : January 22, 2009
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Aphasia Stroke Dyslexia, Acquired Behavioral: One-on-one treatment of reading difficulties

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is a repeated probe design study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multimodal Treatment of Phonological Alexia: Behavioral & fMRI Outcomes
Study Start Date : June 2009
Primary Completion Date : December 2011
Study Completion Date : July 2012
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Change in Real World Reading Skills [ Time Frame: Language testing are conducted two weeks prior to treatment, immediately following end of treatment and 3 months after end of treatment. ]
    Real World Reading Skills was tested using the Woodcock Reading Mastery Test-Revised


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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): NCT00827268


Locations
United States, Florida
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Timothy W. Conway, PhD North Florida/South Georgia Veterans Health System
More Information

Additional Information:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00827268     History of Changes
Other Study ID Numbers: B6699-W
First Posted: January 22, 2009    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017

Keywords provided by VA Office of Research and Development:
Dyslexia
Reading
Aphasia
Stroke

Additional relevant MeSH terms:
Dyslexia
Dyslexia, Acquired
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Learning Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurocognitive Disorders