Therapy for Reading Problems in Adults After Brain Injury | NCT00064805

Studies
Therapy for Reading Problems in Adults After Brain Injury

NCT00064805

Sponsor

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

Status

Completed

Last Update Posted

Aug 15, 2014Estimated

Enrollment

58Estimated

Phase

Not Applicable

Conditions

Dyslexia, Acquired
Brain Injuries
Cerebrovascular Accident

Interventions

Cognitive Therapy to Improve Reading

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2002

Primary Completion Date

Jul 2007Actual

Completion Date

Jul 2007Actual

First Submitted Date

Jul 14, 2003

First Submission Date that Met QC Criteria

Jul 14, 2003

First Posted Date

Jul 15, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2014

Last Update Posted Date

Aug 15, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

Collaborators

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

58Estimated

Name	Type	Description	Arm Group Labels	Other Names
Cognitive Therapy to Improve Reading	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improved accuracy and/or speed of reading individual words aloud.

Secondary Outcomes

Measure	Description	Time Frame
Improved accuracy and/or speed of reading text aloud.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rhonda B. Friedman, Ph.D.	Georgetown University Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Georgetown University Medical Center		Washington D.C.	District of Columbia	20057	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10764518	Background	Friedman RB, Lott SN. Rapid word identification in pure alexia is lexical but not semantic. Brain Lang. 2000 May;72(3):219-37. doi: 10.1006/brln.2000.2286.
10210630	Background	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. doi: 10.1006/brln.1999.2054.

ID	Term
D004411	Dyslexia, Acquired
D001930	Brain Injuries
D020521	Stroke
D004410	Dyslexia
D001927	Brain Diseases

ID	Term
D007806	Language Disorders
D003147	Communication Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations