Aphasia, AcquiredNCT05443633
Enhancing Language Function in Aphasia
A study testing individualized speech-language training and standard language intervention in people with Aphasia, Acquired and Language Disorders, run by University of Arizona at 1 site in United States.
Trial summary
Aphasia is an acquired impairment of language, that commonly results from damage to language areas in the brain (typically the left side of the brain). This impairment is seen in many aspects of language, including understanding, speaking, reading and writing. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aphasia, Acquired, Language Disorders, Primary Progressive Aphasia
- What is being tested?
- individualized speech-language training and standard language intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2022to 15 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Present with speech-language impairment (aphasia) caused by stroke or dementia
- A medical diagnosis of primary progressive aphasia (PPA) by a neurologist or physician
- Are native speakers of English
- Present with no contraindications for MRI
- Have adequate (normal or corrected to normal) vision and hearing
Who cannot join
- Individuals diagnosed with mood, anxiety, psychotic or substance abuse disorders.
- Individuals with highly magnetizable metallic implants, including certain dental work, may be excluded due to image quality in MRI.
- Individuals with other neurological disorders besides the ones of interest for the study (e.g., epilepsy, Multiple Sclerosis, Parkinson's Disease)
- Individuals with contraindications for MRI. This includes but is not limited to pacemakers, metallic cardiac pumps, valves, magnetic materials such as surgical clips, implanted electronic perfusion pumps, or any other condition that would preclude proximity to a strong magnetic field.
- Individuals suffering from clinically significant claustrophobia
- Severe systemic disease (e.g., renal failure)
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- Poor overall health
- Individuals who are pregnant
- Individuals with a history of epileptic activity in the past 12 months
- Individuals with a personal or family history of epilepsy or other seizure disorders will not be included in the study.
- Individuals who have had a brain surgery in the past
- Individuals with implanted metallic skull plates or intracranial implants
- Individuals with skin lesions or skull damage
- Individuals who have a history of excessive use of alcohol or drugs
- Individuals with premorbid psychiatric disease affecting communication
- Individuals with severe non-linguistic cognitive disturbances impeding language therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Fatima Jebahi, MS contact
United States1 site, 1 recruiting
- Recruiting
University of Arizona
Tucson, Arizona, 85721-0071
Aneta Kielar, PHD, 520-488-3791, akielar@email.arizona.edu
Fatima Jebahi, MS, fjebahi@email.arizona.edu
About this study
Official title: Enhancing Language Function in Aphasia Using Behavioral Language Intervention
Aphasia is an acquired impairment of language, that commonly results from damage to language areas in the brain (typically the left side of the brain). This impairment is seen in many aspects of language, including understanding, speaking, reading and writing. It is estimated that about 2 million individuals are currently living with aphasia in the United States. Further, about 200,000 Americans acquire aphasia every year (National Aphasia Association, 2020). Aphasia poses significant impact on the affected individuals and their families. Behavioral treatments that target language deficits have been shown to enhance overall communication skills and life satisfaction among individuals with aphasia. Although there is evidence that suggests that treatment is efficacious for individuals with aphasia, the extent of improvement long-term coupled with the neural patterns among those individuals are largely unknown. The current study aims to investigate the efficacy of language-based treatment and its corresponding neural patterns.
Read the detailed description
The purpose of this study is to develop semantic-based treatment to address language deficits in individuals with acquired language disorders. We propose to develop an individually optimized semantic-based protocol for strategy implementation and word finding facilitation among individuals with language disorders.
Phase 1: Following screening, participants who fulfill the inclusion criteria and have consented to participate in the study will undergo baseline cognitive and language assessment, electroencephalography (EEG) recording and the magnetic resonance imaging (MRI) scan. Participants with language disorders will proceed to the following phases.
Phase 2: After baseline assessment, participants will undergo individualized language treatment in which they will learn semantically- or phonologically based strategies to facilitate word finding difficulties, sentence formulation, or challenges in their narration and discourse. The level at which the treatment will be administered will depend on the participants' level of performance determined by the results of the language and cognitive testing done at baseline. Treatment will be administered twice a week for 10 weeks.
Phase 3: Directly following treatment, patients will undergo cognitive and language assessment, EEG recording, and an MRI scan. This is done to test for short-term changes in behavioral abilities and neural patterns.
Phase 4: After 2 months after the treatment, participants will undergo cognitive and language assessment, EEG recording, and an MRI scan. This final phase of testing is done to test for long-term changes in behavioral abilities and neural responses.
- Conditions
- Aphasia, Acquired, Language Disorders, Primary Progressive Aphasia, Stroke, Cerebrovascular
- Being tested
- individualized speech-language training, standard language intervention
- Medical subject headings
- Aphasia, Language Disorders, Aphasia, Primary Progressive, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individualized speech-language trainingBehavioural
Also called active
Language treatment might include lexical, semantic, and interactive treatment. During treatment, patients may be trained to name words by attempting to self-cue lexical retrieval. The therapy moves incrementally through semantic cuing. The semantic treatment will be implemented using the methods described in (Edmonds et al., 2009, 2014).
standard language interventionBehavioural
Also called control
Participants will undergo standard speech-language naming therapy
| Study group | Role | What they receive |
|---|---|---|
| Active therapy group | Experimental | Participants will undergo individualized language treatment in which they will learn semantically- or phonologically based strategies to facilitate word finding difficulties, sentence formulation difficulties, or challenges in their narration and discourse. The level at which the treatment will be administered will depend on the participants' level of performance determined by the results of the language and cognitive testing done at baseline. Treatment will be administered twice a week for 10 weeks. Receives: Behavioral: individualized speech-language training |
| control group | Active comparator | control group will undergo standard speech-language intervention Receives: Behavioral: standard language intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline scores on the naming task
Mean change from baseline scores on the Boston Naming Test: Min score = 0; Max = 60; higher scores indicate better outcome
Measured: through study completion, an average of 1 year
Mean change from baseline scores in aphasia severity
Mean change from baseline scores on the Western Aphasia Battery: Min score = 0; Max = 100; higher scores indicate better outcome
Measured: through study completion, an average of 1 year
Mean change from baseline scores on the language probe task before and after each session
change on on the probe task from before the session; Min =0; Max = 100%; higher scores indicate better outcome
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start30 Oct 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion15 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphasia, 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
- Randomised
- Intervention model
- Factorial
- Model description
- individuals will be randomized to the active intervention or control group (standard care)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aneta Kielar, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443633
- Sponsor's protocol ID
- STUDY00001134
- Status last verified
- Nov 2024
- First submitted
- 29 Jun 2022
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Language Function in Aphasia Using Behavioral Language Intervention
- ClinicalTrials.gov ID
- NCT05443633
- Acronym / sponsor ID
- STUDY00001134
- Conditions
- Aphasia, Acquired, Language Disorders, Primary Progressive Aphasia, Stroke, Cerebrovascular
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 30 Oct 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 5 Jul 2022 (actual)
- 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.
Aphasia is an acquired impairment of language, that commonly results from damage to language areas in the brain (typically the left side of the brain). This impairment is seen in many aspects of language, including understanding, speaking, reading and writing. It is estimated that about 2 million individuals are currently living with aphasia in the United States. Further, about 200,000 Americans acquire aphasia every year (National Aphasia Association, 2020). Aphasia poses significant impact on the affected individuals and their families. Behavioral treatments that target language deficits have been shown to enhance overall communication skills and life satisfaction among individuals with aphasia. Although there is evidence that suggests that treatment is efficacious for individuals with aphasia, the extent of improvement long-term coupled with the neural patterns among those individuals are largely unknown. The current study aims to investigate the efficacy of language-based treatment and its corresponding neural patterns.
Detailed description
The purpose of this study is to develop semantic-based treatment to address language deficits in individuals with acquired language disorders. We propose to develop an individually optimized semantic-based protocol for strategy implementation and word finding facilitation among individuals with language disorders.
Phase 1: Following screening, participants who fulfill the inclusion criteria and have consented to participate in the study will undergo baseline cognitive and language assessment, electroencephalography (EEG) recording and the magnetic resonance imaging (MRI) scan. Participants with language disorders will proceed to the following phases.
Phase 2: After baseline assessment, participants will undergo individualized language treatment in which they will learn semantically- or phonologically based strategies to facilitate word finding difficulties, sentence formulation, or challenges in their narration and discourse. The level at which the treatment will be administered will depend on the participants' level of performance determined by the results of the language and cognitive testing done at baseline. Treatment will be administered twice a week for 10 weeks.
Phase 3: Directly following treatment, patients will undergo cognitive and language assessment, EEG recording, and an MRI scan. This is done to test for short-term changes in behavioral abilities and neural patterns.
Phase 4: After 2 months after the treatment, participants will undergo cognitive and language assessment, EEG recording, and an MRI scan. This final phase of testing is done to test for long-term changes in behavioral abilities and neural responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- individuals will be randomized to the active intervention or control group (standard care)
| Arm | Type | Receives |
|---|---|---|
| Active therapy group | Experimental | Behavioral: individualized speech-language trainingParticipants will undergo individualized language treatment in which they will learn semantically- or phonologically based strategies to facilitate word finding difficulties, sentence formulation difficulties, or challenges in their narration and discourse. The level at which the treatment will be administered will depend on the participants' level of performance determined by the results of the language and cognitive testing done at baseline. Treatment will be administered twice a week for 10 weeks. |
| control group | Active comparator | Behavioral: standard language interventioncontrol group will undergo standard speech-language intervention |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Present with speech-language impairment (aphasia) caused by stroke or dementia
- A medical diagnosis of primary progressive aphasia (PPA) by a neurologist or physician
- Are native speakers of English
- Present with no contraindications for MRI
- Have adequate (normal or corrected to normal) vision and hearing
Key exclusion criteria (16 listed)
- Individuals diagnosed with mood, anxiety, psychotic or substance abuse disorders.
- Individuals with highly magnetizable metallic implants, including certain dental work, may be excluded due to image quality in MRI.
- Individuals with other neurological disorders besides the ones of interest for the study (e.g., epilepsy, Multiple Sclerosis, Parkinson's Disease)
- Individuals with contraindications for MRI. This includes but is not limited to pacemakers, metallic cardiac pumps, valves, magnetic materials such as surgical clips, implanted electronic perfusion pumps, or any other condition that would preclude proximity to a strong magnetic field.
- Individuals suffering from clinically significant claustrophobia
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 |
|---|---|---|
| individualized speech-language trainingAlso: activeLanguage treatment might include lexical, semantic, and interactive treatment. During treatment, patients may be trained to name words by attempting to self-cue lexical retrieval. The therapy moves incrementally through semantic cuing. The semantic treatment will be implemented using the methods described in (Edmonds et al., 2009, 2014). | Behavioural | Active therapy group |
| standard language interventionAlso: controlParticipants will undergo standard speech-language naming therapy | Behavioural | control group |
Primary outcome
Mean change from baseline scores on the naming task
Time frame: through study completion, an average of 1 year
Mean change from baseline scores on the Boston Naming Test: Min score = 0; Max = 60; higher scores indicate better outcome
Mean change from baseline scores in aphasia severity
Time frame: through study completion, an average of 1 year
Mean change from baseline scores on the Western Aphasia Battery: Min score = 0; Max = 100; higher scores indicate better outcome
Mean change from baseline scores on the language probe task before and after each session
Time frame: through study completion, an average of 1 year
change on on the probe task from before the session; Min =0; Max = 100%; higher scores indicate better outcome
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Fatima Jebahi, MS contact
Aneta Kielar, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing individualized speech-language training and standard language intervention in people with Aphasia, Acquired and Language Disorders, run by University of Arizona 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 5 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 9 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aneta Kielar, PhD (15204883791, akielar@email.arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline scores on the naming task (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. 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 9 Dec 2024.