AphasiaNCT02664506
Theory-Driven Treatment of Language and Cognitive Processes in Aphasia
A study testing Word repetition after a time delay. in people with Aphasia, run by Temple University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aphasia
- What is being tested?
- Word repetition after a time delay.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 30 Nov 2025
- 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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
- 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.
Who cannot join
- History of mental illness
- Alcohol/substance abuse
- Pregnant
- Unable to personally give informed consent
- Control participants:
- History of neurological disease or language disability
- Histories for mental illness
- Alcohol/substance abuse.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Aphasia
- Being tested
- Word repetition after a time delay.
- Medical subject headings
- Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Word repetition after a time delay.Behavioural
Also called Repetition after delay
This is a behavioral intervention, Word repetition after a time delay. Individuals listen to words and repeat them after 5 or 10 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Word repetition after a tiem delay | Experimental | 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. Receives: Behavioral: Word repetition after a time delay. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Verbal Short-Term Memory (STM) Span at 6 weeks
It is expected that this treatment will increase verbal STM span (primary)
Measured: Baseline and 6 weeks
Secondary outcomes (2)
Change in proportion of words retrieved in picture naming
More words will be retrieved accurately in picture naming.
Measured: Post treatment, after 6 weeks of treatment
Discourse measures, changes in rates of context information units
Proportion of content information units will increase as a consequence of htis therapy.
Measured: Post treatment, after 6 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startMar 2014
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Nadine Martin, Temple University
- Investigators
- Nadine Martin, Ph.D., Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664506
- Sponsor's protocol ID
- 21987
- Other IDs
- 5R01DC013196
- Status last verified
- Apr 2024
- First submitted
- 15 Jan 2016
- Last updated
- 11 Apr 2024
- 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 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Theory-Driven Treatment of Language and Cognitive Processes in Aphasia
- ClinicalTrials.gov ID
- NCT02664506
- Acronym / sponsor ID
- 21987
- Conditions
- Aphasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- University of Pennsylvania, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Mar 2014 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 27 Jan 2016 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Word repetition after a tiem delay | Experimental | Behavioral: Word repetition after a time 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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Aphasia
- Single left hemisphere lesions
- Right handed
- At least six months post-stroke
- Aged 21 to 80
Key exclusion criteria (8 listed)
- History of mental illness
- Alcohol/substance abuse
- Pregnant
- Unable to personally give informed consent
- History of neurological disease or language disability
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 |
|---|---|---|
| Word repetition after a time delay.Also: Repetition after delayThis is a behavioral intervention, Word repetition after a time delay. Individuals listen to words and repeat them after 5 or 10 seconds. | Behavioural | Word repetition after a tiem delay |
Primary outcome
Change from Baseline Verbal Short-Term Memory (STM) Span at 6 weeks
Time frame: Baseline and 6 weeks
It is expected that this treatment will increase verbal STM span (primary)
2 secondary outcomes
Change in proportion of words retrieved in picture naming
Time frame: Post treatment, after 6 weeks of treatment
Discourse measures, changes in rates of context information units
Time frame: Post treatment, after 6 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Aphasia
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Expressive Aphasia, Aphasia Following Cerebral Infarction
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Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
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Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
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Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
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.
Nadine Martin, Ph.D. principal investigator
Temple 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 Word repetition after a time delay. in people with Aphasia, run by Temple 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 12 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 11 Apr 2024. 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?
Results are not available in the source record.
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?
Change from Baseline Verbal Short-Term Memory (STM) Span at 6 weeks (time frame: Baseline and 6 weeks). 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 11 Apr 2024.