Multimodal Treatment of Phonological Alexia: Behavioral & fMRI Outcomes - Full Text View

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00827268

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 I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Multimodal Treatment of Phonological Alexia: Behavioral & fMRI Outcomes

Resource links provided by NLM:

MedlinePlus related topics: Aphasia

U.S. FDA Resources

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
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Experimental 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

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

Contacts

Contact: Timothy W Conway, PhD

(352) 376-1611 ext 5395

twc@phhp.ufl.edu

Locations

United States, Florida
North Florida/South Georgia Veterans Health System	Recruiting
Gainesville, Florida, United States, 32608
Contact: Ellen Mueller, MA 800-324-8387 ext 6181 brrc@va.gov
Principal Investigator: Timothy W. Conway, PhD
Brooks Center for Rehabilitation Studies	Recruiting
Jacksonville, Florida, United States, 32216
Contact: Ellen Mueller, MA 352-376-1611 ext 5314 ellen.mueller@va.gov

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Timothy W. Conway, PhD

North Florida/South Georgia Veterans Health System

More Information

Additional Information:

Main research facility in which this study is being run. This link exits the ClinicalTrials.gov site

Publications:

Conway TW, Heilman P, Rothi LJ, Alexander AW, Adair J, Crosson BA, Heilman KM. Treatment of a case of phonological alexia with agraphia using the Auditory Discrimination in Depth (ADD) program. J Int Neuropsychol Soc. 1998 Nov;4(6):608-20.

Raymer AM, Beeson P, Holland A, Kendall D, Maher LM, Martin N, Murray L, Rose M, Thompson CK, Turkstra L, Altmann L, Boyle M, Conway T, Hula W, Kearns K, Rapp B, Simmons-Mackie N, Gonzalez Rothi LJ. Translational research in aphasia: from neuroscience to neurorehabilitation. J Speech Lang Hear Res. 2008 Feb;51(1):S259-75.

Kendall DL, Rosenbek JC, Heilman KM, Conway T, Klenberg K, Gonzalez Rothi LJ, Nadeau SE. Phoneme-based rehabilitation of anomia in aphasia. Brain Lang. 2008 Apr;105(1):1-17. Epub 2008 Jan 30.

Kendall DL, Nadeau SE, Conway T, Fuller RH, Riestra A, Gonzalez Rothi LJ. Treatability of different components of aphasia - insights from a case study. J Rehabil Res Dev. 2006 May-Jun;43(3):323-36.

Kendall DL, Rodriguez AD, Rosenbek JC, Conway T, Gonzalez Rothi LJ. Influence of intensive phonomotor rehabilitation on apraxia of speech. J Rehabil Res Dev. 2006 May-Jun;43(3):409-18.

Responsible Party:	Department of Veterans Affairs ( Conway, Timothy - Principal Investigator )
Study ID Numbers:	B6699W, B6698W
Study First Received:	January 20, 2009
Last Updated:	September 1, 2009
ClinicalTrials.gov Identifier:	NCT00827268 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Dyslexia
Reading
Aphasia
Stroke

Study placed in the following topic categories:

Dyslexia, Acquired
Speech Disorders
Cerebral Infarction
Aphasia
Stroke
Vascular Diseases
Central Nervous System Diseases
Dyslexia
Language Disorders
Learning Disorders
Brain Diseases

Cerebrovascular Disorders
Cognition Disorders
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Dementia
Neurobehavioral Manifestations
Delirium
Communication Disorders

Additional relevant MeSH terms:

Dyslexia, Acquired
Speech Disorders
Aphasia
Stroke
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Dyslexia
Language Disorders
Learning Disorders

Brain Diseases
Cerebrovascular Disorders
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Cardiovascular Diseases
Neurobehavioral Manifestations
Communication Disorders

ClinicalTrials.gov processed this record on September 11, 2009