Dyslexia, AcquiredNCT00064805
Therapy for Reading Problems in Adults After Brain Injury
A study testing Cognitive Therapy to Improve Reading in people with Dyslexia, Acquired and Brain Injuries, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslexia, Acquired, Brain Injuries, Cerebrovascular Accident
- What is being tested?
- Cognitive Therapy to Improve Reading
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Jul 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Medical Center
Washington D.C., District of Columbia, 20057
About this study
Official title: Cognitively-based Treatments of Acquired Dyslexias
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.
Read the 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.
- Conditions
- Dyslexia, Acquired, Brain Injuries, Cerebrovascular Accident
- Being tested
- Cognitive Therapy to Improve Reading
- Keywords
- Cognitive therapy, Aphasia therapy, Alexia, Acquired dyslexia, Phonological deficits, Orthographic deficits, Brain disorders, Brain injury, Stroke
- Medical subject headings
- Dyslexia, Acquired, Brain Injuries, Stroke, Dyslexia, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Therapy to Improve ReadingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved accuracy and/or speed of reading individual words aloud.
Secondary outcomes (1)
Improved accuracy and/or speed of reading text aloud.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2003 (estimated)
- Study startAug 2002
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Dyslexia, AcquiredStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Rhonda B. Friedman, Ph.D., Principal investigator, Georgetown University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00064805
- Sponsor's protocol ID
- R01HD036019
- Status last verified
- Apr 2014
- First submitted
- 14 Jul 2003
- Last updated
- 15 Aug 2014
- Results posted
- No
Publications
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.
PubMed 10764518Nitzberg 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.
PubMed 10210630Friedman 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. doi: 10.1016/s0028-3932(01)00098-7.
PubMed 11640944Marchand 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. doi: 10.1016/j.bandl.2004.10.013. Epub 2004 Dec 15.
PubMed 15862852Lott 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.
PubMed 18513760Lott 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. doi: 10.1080/02687030903580333.
PubMed 21170161Lacey 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.
PubMed 20574915Kurland 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. doi: 10.1007/s11682-008-9027-2.
PubMed 20119495
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitively-based Treatments of Acquired Dyslexias
- ClinicalTrials.gov ID
- NCT00064805
- Acronym / sponsor ID
- R01HD036019
- Conditions
- Dyslexia, Acquired, Brain Injuries, Cerebrovascular Accident
- Keywords
- Cognitive therapy, Aphasia therapy, Alexia, Acquired dyslexia, Phonological deficits, Orthographic deficits, Brain disorders, Brain injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Aug 2002
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 15 Jul 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Therapy to Improve Reading | Behavioural | – |
Primary outcome
Improved accuracy and/or speed of reading individual words aloud.
1 secondary outcome
Improved accuracy and/or speed of reading text aloud.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
- Background: PubMed 10764518Friedman 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.
- Background: PubMed 10210630Nitzberg 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.
- Background: PubMed 11640944Friedman 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. doi: 10.1016/s0028-3932(01)00098-7.
- Background: PubMed 15862852Marchand 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. doi: 10.1016/j.bandl.2004.10.013. Epub 2004 Dec 15.
- Background: PubMed 18513760Lott 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.
- Background: PubMed 21170161Lott 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. doi: 10.1080/02687030903580333.
- Background: PubMed 20574915Lacey 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.
- Background: PubMed 20119495Kurland 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. doi: 10.1007/s11682-008-9027-2.
- Cognitive Neuropsychology Lab at Georgetown University Medical CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rhonda B. Friedman, Ph.D. principal investigator
Georgetown University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Therapy to Improve Reading in people with Dyslexia, Acquired and Brain Injuries, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved accuracy and/or speed of reading individual words aloud.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00064805, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2014.