- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02664506
Theory-Driven Treatment of Language and Cognitive Processes in Aphasia
The aim of this research is to translate a theory of the cognitive relationship between verbal short--term memory (STM) and word processing impairments in aphasia to treatment approaches for language impairment in aphasia. It has been proposed that the co-occurrence of these impairments is due to a disruption of cognitive processes that support both abilities: maintenance of activated semantic and phonological representations of words, hereafter the 'activation--maintenance hypothesis'.
This hypothesis will be tested in the context of a treatment approach that aims to improve word processing and verbal STM abilities. The grant supporting this work has ended. therefore, participants are entered into the study by invitation only.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Based on research of word processing and verbal STM impairments in aphasia, it has been proposed that the co-occurrence of these impairments is due to a disruption of cognitive processes that support both abilities: maintenance of activated semantic and phonological representations of words, hereafter the 'activation--maintenance hypothesis'.
This hypothesis will be tested in the context of a treatment approach that aims to improve word processing and verbal STM abilities. Recently, the importance of treatment research has been emphasized as a critical testing ground for theories of language processing. Although it has been demonstrated that associations between impairments of word processing and reduced verbal STM capacity support the 'activation-maintenance hypothesis', direct treatments to improve the ability to maintain activation of word representations will serve as a stronger test of this hypothesis. First, empirical support will be established for the hypothesis that impairment to short-term maintenance of activated semantic and phonological representations of words impairs language and verbal STM abilities in aphasia and that direct treatment of this deficit will improve both abilities (Specific Aim 1). Second, the effects of this treatment will be compared under two administration conditions, high and low intensity (Specific aim 2). Finally, the neural regions associated with semantic STM and phonological STM will be investigated using voxel--based lesion--symptom mapping (Bates et al., 2003) (Specific Aim 3).
This research represents a unique attempt to apply more recent processing theories of aphasia to treatment of the disorder.The outcomes will have important implications for aphasia rehabilitation research.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19121
- Temple University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Experimental participants:
Inclusion Criteria:
- Aphasia
- Single left hemisphere lesions
- Right handed
- At least six months post-stroke
- Aged 21 to 80
- High-school educated with English as their primary language
- Passed an audiometric pure tone, air conduction screening at 25 dB HL at 1K, 2K and 4K Hz for at least one ear (with or without correction)
- Demonstrate adequate vision with or without correction.
- Will not exclude individuals with a mild apraxia of speech or mild dysarthria of speech.
Exclusion Criteria:
- History of mental illness
- Alcohol/substance abuse
- Pregnant
- Unable to personally give informed consent
Control participants:
Inclusion Criteria:
- Aged 21 to 80
- High school educated or above
- Pass an audiometric pure tone, air conduction screening at 25 dB HL at 1K, 2K and 4K Hz for at least one ear.
Exclusion Criteria:
- History of neurological disease or language disability
- Histories for mental illness
- Alcohol/substance abuse.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Word repetition after a tiem delay
People with Aphasia and Short-Term Memory impairment will receive a behavioral treatment: Word repetition after a time delay.
This is the intervention: repetition of words after a 5 or 10 second delay.
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This is a behavioral intervention, Word repetition after a time delay.
Individuals listen to words and repeat them after 5 or 10 seconds.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline Verbal Short-Term Memory (STM) Span at 6 weeks
Time Frame: Baseline and 6 weeks
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It is expected that this treatment will increase verbal STM span (primary)
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Baseline and 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in proportion of words retrieved in picture naming
Time Frame: Post treatment, after 6 weeks of treatment
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More words will be retrieved accurately in picture naming.
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Post treatment, after 6 weeks of treatment
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Discourse measures, changes in rates of context information units
Time Frame: Post treatment, after 6 weeks of treatment
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Proportion of content information units will increase as a consequence of htis therapy.
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Post treatment, after 6 weeks of treatment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nadine Martin, Ph.D., Temple University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21987
- 5R01DC013196 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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