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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00064805
Other study ID # R01HD036019
Secondary ID
Status Completed
Phase N/A
First received July 14, 2003
Last updated August 13, 2014
Start date August 2002
Est. completion date July 2007

Study information

Verified date April 2014
Source Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

Adults who sustain brain damage due to stroke, head injury, or traumatic surgery may develop difficulty reading. This study examines the effectiveness of behavior-based programs to improve reading ability in these individuals.


Description:

Acquired disorders of reading (acquired dyslexia) are common in patients with aphasia subsequent to left hemisphere stroke. Even when language functions recover sufficiently to enable the patient to return to work, continuing dyslexia often interferes significantly with job performance. This study will evaluate cognitive therapies for the treatment of acquired dyslexia.

Each therapy is based upon a cognitive neuropsychological model of reading; the therapies target specific types of reading deficit and stem from the question of re-learning versus re-organization of function. The therapies focus on dyslexic disorders stemming from the following underlying deficits: 1) impaired access to the orthographic word form from the visual modality (pure alexia); 2) impaired orthographic/phonologic connections (phonologic/deep dyslexia); and 3) decreased ability to hold phonologic codes in memory (phonologic text alexia).

Participants in this study will undergo a comprehensive and detailed battery of reading and reading-related tests to determine the underlying impairment causing the reading deficit. Based upon the results of these tests, the patient's dyslexic disorder will be characterized and, if appropriate, the patient will be assigned to one of the treatment programs devised specifically for that type of deficit. Treatment programs are evaluated for efficacy by comparing the accuracy and speed of reading pre- and post-treatment.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date July 2007
Est. primary completion date July 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria

- Reading deficit subsequent to stroke, traumatic brain injury, brain surgery, or other brain damage

- Ability to attend 2-3 sessions per week for several months at Georgetown University in Washington, DC

Exclusion Criteria

- History of developmental dyslexia or learning disabilities

- Best corrected vision less than 20/40

- Less than 10 years of formal education

- Significant memory or comprehension problems

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
Cognitive Therapy to Improve Reading


Locations

Country Name City State
United States Georgetown University Medical Center Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (8)

Friedman RB, Lott SN. Rapid word identification in pure alexia is lexical but not semantic. Brain Lang. 2000 May;72(3):219-37. — View Citation

Friedman RB, Sample DM, Lott SN. The role of level of representation in the use of paired associate learning for rehabilitation of alexia. Neuropsychologia. 2002;40(2):223-34. — View Citation

Kurland J, Cortes CR, Wilke M, Sperling AJ, Lott SN, Tagamets MA, Vanmeter J, Friedman RB. Neural Mechanisms Underlying Learning following Semantic Mediation Treatment in a case of Phonologic Alexia. Brain Imaging Behav. 2008 Sep;2(3):147. — View Citation

Lacey EH, Lott SN, Snider SF, Sperling A, Friedman RB. Multiple Oral Re-reading treatment for alexia: The parts may be greater than the whole. Neuropsychol Rehabil. 2010 Aug;20(4):601-23. doi: 10.1080/09602011003710993. Epub 2010 Jul 6. Erratum in: Neuropsychol Rehabil. 2010 Dec;20(6):940. — View Citation

Lott SN, Carney AS, Glezer LS, Friedman RB. Overt use of a tactile-kinesthetic strategy shifts to covert processing in rehabilitation of letter-by-letter reading. Aphasiology. 2010 Nov;24(11):1424-1442. — View Citation

Lott SN, Sample DM, Oliver RT, Lacey EH, Friedman RB. A patient with phonologic alexia can learn to read "much" from "mud pies". Neuropsychologia. 2008 Aug;46(10):2515-23. doi: 10.1016/j.neuropsychologia.2008.04.004. Epub 2008 Apr 16. — View Citation

Marchand Y, Friedman RB. Impaired oral reading in two atypical dyslexics: a comparison with a computational lexical-analogy model. Brain Lang. 2005 Jun;93(3):255-66. Epub 2004 Dec 15. — View Citation

Nitzberg Lott S, Friedman RB. Can treatment for pure alexia improve letter-by-letter reading speed without sacrificing accuracy? Brain Lang. 1999 May;67(3):188-201. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Improved accuracy and/or speed of reading individual words aloud.
Secondary Improved accuracy and/or speed of reading text aloud.
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