Multimodal Treatment of Phonological Alexia: Behavioral & fMRI Outcomes
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Aphasia Stroke Dyslexia, Acquired |
Behavioral: One-on-one treatment of reading difficulties Radiation: Functional Magnetic Resonance Imaging (fMRI) |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multimodal Treatment of Phonological Alexia: Behavioral & fMRI Outcomes |
- Behavioral testing and fMRI [ Time Frame: Language testing and fMRI sessions are conducted two weeks prior to treatment, immediately following end of treatment and 3 months after end of treatment. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 18 |
| Study Start Date: | June 2009 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Adults with post-stroke reading difficulties (phonological alexia), >3 months post-stroke, native English speakers, able to undergo an MRI scan.
|
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.
|
|
Experimental: Arm 2
fMRI during reading pseudowords and during repeating pseudowords, as well as finger tapping (non-language task)
|
Radiation: Functional Magnetic Resonance Imaging (fMRI)
fMRI during reading pseudowords and during repeating pseudowords, as well as finger tapping (non-language task).
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| United States, Florida | |
| North Florida/South Georgia Veterans Health System | |
| Gainesville, Florida, United States, 32608 | |
| Principal Investigator: | Timothy W. Conway, PhD | North Florida/South Georgia Veterans Health System |
More Information
Additional Information:
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00827268 History of Changes |
| Other Study ID Numbers: | B6699-W |
| Study First Received: | January 20, 2009 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Dyslexia Reading Aphasia Stroke |
Additional relevant MeSH terms:
|
Dyslexia, Acquired Dyslexia Aphasia Stroke Speech Disorders Language Disorders Communication Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Learning Disorders Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Mental Disorders Diagnosed in Childhood Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013