Multimodal Treatment of Phonological Alexia: Behavioral & fMRI Outcomes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00827268
First received: January 20, 2009
Last updated: October 15, 2013
Last verified: October 2013
  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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827268

Locations
United States, Florida
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
Investigators
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: October 15, 2013
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 July 28, 2014