AnomiaNCT00494520
Cognitive Therapy to Improve Word Finding
A study testing Errorful training condition and Errorless training condition in people with Anomia and Aphasia, run by Georgetown University at 1 site in United States.
Trial summary
Adults who sustain brain damage due to stroke, traumatic injury or surgery may develop difficulty finding words. This study compares the effectiveness of two behavior-based programs to improve picture naming ability in these individuals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anomia, Aphasia, Traumatic Brain Injury
- What is being tested?
- Errorful training condition and Errorless training condition
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Jun 2009
- 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
- Word finding difficulty subsequent to stroke, traumatic brain injury, brain surgery or other brain damage occuring at least 6 month prior to participation
- Ability to attend 2 sessions per week for several months at Georgetown University in Washington, DC
Who cannot join
- History of learning disabilities
- Best corrected vision less than 20/40
- Corrected hearing within functional limits
- Less than 10 years 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: Learning Paradigms in Aphasia Rehabilitation
Adults who sustain brain damage due to stroke, traumatic injury or surgery may develop difficulty finding words. This study compares the effectiveness of two behavior-based programs to improve picture naming ability in these individuals.
Read the detailed description
Difficulty finding words is common in patients with aphasia subsequent to left hemisphere stroke. This study will compare two cognitive therapies for the treatment of acquired word finding difficulties. The therapies use different types of cues. All participants will receive both therapies. Participants in this study will undergo a comprehensive and detailed assessment of language and other cognitive skills. The two treatments will be compared for their efficacy.
- Conditions
- Anomia, Aphasia, Traumatic Brain Injury, Cerebrovascular Accident
- Being tested
- Errorful training condition, Errorless training condition
- Keywords
- Anomia, Aphasia, Traumatic Brain Injury, Cerebrovascular Accident
- Medical subject headings
- Anomia, Aphasia, Brain Injuries, Traumatic, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Errorful training conditionProcedure or surgery
Errorful training condition: Participant saw a picture and named it without any cues. If an error was produced, the cue with the least amount of information was provided (e.g. for "pumpkin", "pu"). Cues with increasing information were provided until the picture was correctly named (e.g. for "pumpkin": "pump", "pumpki", then "pumpkin"). Once the correct name was provided, the trial ended.
Errorless training conditionProcedure or surgery
Errorless learning (EL) condition: Participant saw a picture with its name, and repeated the word. The participant continued to name the picture as the auditory cues provided less and less of the word (e.g. for "banana" she would hear "banan", "bana" then "ba" and finally no cue). If an error was produced at any stage, the whole word was presented, the participant repeated it, and the trial ended.
| Study group | Role | What they receive |
|---|---|---|
| Errorful training condition | Experimental | A type of anomia rehabilitation paradigm which allows for errors. The intervention involves providing minimal auditory cues to allow for errors in picture naming. Receives: Procedure: Errorful training condition |
| Errorless training condition | Experimental | A type of anomia rehabilitation paradigm in which the situation surrounding the performance of the desired task (i.e., picture naming) is controlled to prevent errors. The intervention involves providing maximal auditory cues to prevent errors in picture naming. Receives: Procedure: Errorless training condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved picture naming of trained words.
Overall accuracy of named trained items
Measured: Following conclusion of word treatment.
Secondary outcomes (3)
Improved picture naming of trained words.
Overall accuracy of named trained items
Measured: At 6 months after conclusion of word treatment
Improved picture naming of untrained words.
Overall accuracy of named untrained items
Measured: Following conclusion of word treatment.
Improved picture naming of untrained words.
Overall accuracy of named untrained items
Measured: At 6 months after conclusion of word treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2007 (estimated)
- Study startJul 2004
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnomiaStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rhonda B. Friedman, Ph.D., Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494520
- Sponsor's protocol ID
- R01DC006934-01
- Status last verified
- Apr 2014
- First submitted
- 28 Jun 2007
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Paradigms in Aphasia Rehabilitation
- ClinicalTrials.gov ID
- NCT00494520
- Acronym / sponsor ID
- R01DC006934-01
- Conditions
- Anomia, Aphasia, Traumatic Brain Injury, Cerebrovascular Accident
- Keywords
- Anomia, Aphasia, Traumatic Brain Injury, Cerebrovascular Accident
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- Jul 2004
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 29 Jun 2007 (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, traumatic injury or surgery may develop difficulty finding words. This study compares the effectiveness of two behavior-based programs to improve picture naming ability in these individuals.
Detailed description
Difficulty finding words is common in patients with aphasia subsequent to left hemisphere stroke. This study will compare two cognitive therapies for the treatment of acquired word finding difficulties. The therapies use different types of cues. All participants will receive both therapies. Participants in this study will undergo a comprehensive and detailed assessment of language and other cognitive skills. The two treatments will be compared for their efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Errorful training condition | Experimental | Procedure: Errorful training conditionA type of anomia rehabilitation paradigm which allows for errors. The intervention involves providing minimal auditory cues to allow for errors in picture naming. |
| Errorless training condition | Experimental | Procedure: Errorless training conditionA type of anomia rehabilitation paradigm in which the situation surrounding the performance of the desired task (i.e., picture naming) is controlled to prevent errors. The intervention involves providing maximal auditory cues to prevent errors in picture naming. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Word finding difficulty subsequent to stroke, traumatic brain injury, brain surgery or other brain damage occuring at least 6 month prior to participation
- Ability to attend 2 sessions per week for several months at Georgetown University in Washington, DC
Key exclusion criteria (5 listed)
- History of learning disabilities
- Best corrected vision less than 20/40
- Corrected hearing within functional limits
- Less than 10 years 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 |
|---|---|---|
| Errorful training conditionErrorful training condition: Participant saw a picture and named it without any cues. If an error was produced, the cue with the least amount of information was provided (e.g. for "pumpkin", "pu"). Cues with increasing information were provided until the picture was correctly named (e.g. for "pumpkin": "pump", "pumpki", then "pumpkin"). Once the correct name was provided, the trial ended. | Procedure or surgery | Errorful training condition |
| Errorless training conditionErrorless learning (EL) condition: Participant saw a picture with its name, and repeated the word. The participant continued to name the picture as the auditory cues provided less and less of the word (e.g. for "banana" she would hear "banan", "bana" then "ba" and finally no cue). If an error was produced at any stage, the whole word was presented, the participant repeated it, and the trial ended. | Procedure or surgery | Errorless training condition |
Primary outcome
Improved picture naming of trained words.
Time frame: Following conclusion of word treatment.
Overall accuracy of named trained items
3 secondary outcomes
Improved picture naming of trained words.
Time frame: At 6 months after conclusion of word treatment
Improved picture naming of untrained words.
Time frame: Following conclusion of word treatment.
Improved picture naming of untrained words.
Time frame: At 6 months after conclusion of word treatment
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 19 Sep 2017.
- Cognitive Neuropsychology Lab at Georgetown University Medical CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Semantic Rehabilitation for Patients With Primary Progressive Semantic Aphasia
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Ecological Momentary Intervention for Post-Stroke Anomia
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Criterion-learning Naming Treatment For Addressing Comprehension Deficits in Aphasia
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Errorful training condition and Errorless training condition in people with Anomia and Aphasia, run by Georgetown University 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 5 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 19 Sep 2017. 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 picture naming of trained words. (time frame: Following conclusion of word treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2017.