AphasiaNCT02416856
Brain Connectivity Supporting Language Recovery in Aphasia
An observational study of Aphasia and Stroke, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The integrity of structural connectivity supporting cortical regions in the left brain hemisphere is hypothesized to enable treatment-induced naming recovery in persons with language difficulties after a stroke (aphasia). Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Aphasia, Stroke, Speech Disorders
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to May 2017
- Phase
- Observational
- 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: No new patients will be recruited for the current project. We will rely solely on data collection in the tDCS-Trial (U01 DC011739, period 7/1/2012-6/31/2017). All information used in our experiments will be available as a result of the standardized set of tests that patients undergo in the trial.
Who may be able to join
- Patients must be willing and able to give informed consent.
- Patients must be willing and able to comply with study requirements.
- Patients must be between 25- and 80-years of age.
- Patients must be native English speakers.
- Patients must be pre-morbidly right-handed.
- Patients must have sustained a one-time ischemic stroke in the left-hemisphere.
Show all 10Show fewer
- Patients must be greater than 6-months post-stroke.
- Patients must have an aphasia diagnosis as confirmed by the Western Aphasia Battery-Revised.
- Patients must be MRI-compatible (e.g., no metal implants, not claustrophobic, etc.).
- Patients must achieve at least 65% accuracy on naming task during screening -
Who cannot join
- History of brain surgery
- Seizures during the previous 12 months
- Sensitive scalp (per patient report)
- Able to overtly name more than an average of 140 out of 175 items during the pre-treatment picture naming test (Philadelphia Naming Test) during Visits 2 or 3.
- Unable to overtly name at least an average of 5 out of 80 items during the pre-treatment fMRI sessions during Visits 2 or 3.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
The integrity of structural connectivity supporting cortical regions in the left brain hemisphere is hypothesized to enable treatment-induced naming recovery in persons with language difficulties after a stroke (aphasia). The investigators will map whole brain connectivity (i.e., the brain connectome) to investigate the role of cortical connectivity in impairment (Aim 1) and recovery (Aim 2) in patients with aphasia undergoing treatment. This information will be used to construct personalized markers of anomia treatment outcome (Aim 3), which may serve as a guide for speech-language pathologists and neurologists when facing patient management decisions.
Read the detailed description
Aphasia, an impairment of language processing, is one of the most common consequences of strokes affecting the dominant brain hemisphere4. Patients with aphasia are usually incapable of working, and their interactions with family and friends are often severely affected. The hallmark deficit of aphasia is the inability to name objects or people (anomia)12. The severity of anomia is closely related to a poor quality of life.
While many patients with aphasia exhibit some language recovery in the first days to weeks after the stroke, 30-40% persist with long lasting naming impairments4. Fortunately, speech therapy can be very effective to improve naming for some patients with chronic aphasia5-8. However, it is well recognized among clinicians that speech therapy can be ineffective for other patients, making it difficult to predict how and why some patients benefit from naming treatment, while others show little or no improvement.
Here, the investigators propose to evaluate whether naming impairment and naming recovery are related to the extent of structural damage to the cortical language network. Importantly, the investigators will evaluate damage as the combined effect of cortical necrosis and cortical disconnection. The investigators hypothesize that assessing anomia as being either due to gray matter necrosis or due to cortical disconnection constitutes a false dichotomy since most chronic patients exhibit gray and white matter damage. Furthermore, the investigators propose that disconnection of seemingly spared cortical areas has up till now been underappreciated in patients with stroke due to limitations in brain connectivity assessment tools. By examining only areas of cortical necrosis without considering disconnected areas, one may underestimate the magnitude of language network damage. A better understanding of the effects from both cortical damage and disconnection on anomia and its recovery could lead to an improved clinical management of aphasia.
The investigators will employ the innovative concept of the brain connectome, i.e., the individualized map of neural connections in the brain, to evaluate whether naming recovery is supported by preserved gray matter and preserved connectivity involving key language areas in the left hemisphere. The investigators propose that left frontal and left temporal connectivity mapped based on the individual's connectome is an important explanatory variable towards naming impairment and recovery.
The investigators believe that this research is significant for the three main reasons. First, it can have a direct clinical impact by providing a better understanding of which patients can benefit from therapy. Second, it can unveil the neurobiological mechanisms supporting language recovery, improving our understanding of brain plasticity related to language rehabilitation. Finally, if disconnection contributes to language impairment, our methods can be developed to test specific theories of language organization in the brain. The significance of these aspects is explained in detail below.
- Conditions
- Aphasia, Stroke, Speech Disorders, Communications Disorders
- Keywords
- Aphasia, Brain, Stimulation, Communication, Stroke, Speech Disorders, Communications Disorders, Neurobehavioral Manifestations, Neurologic Manifestations, Nervous System Diseases, Signs and Symptoms
- Medical subject headings
- Aphasia, Stroke, Speech Disorders, Communication Disorders, Communication, Neurobehavioral Manifestations, Neurologic Manifestations, Nervous System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in naming performance as assessed by the number of correctly spoken words after therapy
The primary outcome measure of this study is the objective improvement in the number of correctly spoken words after therapy. This study is also aimed at evaluating the neurological mechanisms (i.e., integrity of brain networks after stroke) that enable therapy-induced improvement.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startJun 2014
- Primary completionMay 2017
- Study completionMay 2017
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.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), University of South Carolina
- Responsible party
- Sponsor
- Investigators
- Leonardo F Bonilha, MD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416856
- Sponsor's protocol ID
- R01-Bonilha
- Other IDs
- R01DC014021
- Status last verified
- May 2018
- First submitted
- 7 Apr 2015
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Connectivity Supporting Language Recovery in Aphasia
- ClinicalTrials.gov ID
- NCT02416856
- Acronym / sponsor ID
- R01-Bonilha
- Conditions
- Aphasia, Stroke, Speech Disorders, Communications Disorders
- Keywords
- Aphasia, Brain, Stimulation, Communication, Stroke, Speech Disorders, Communications Disorders, Neurobehavioral Manifestations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), University of South Carolina
- Study start
- Jun 2014
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 15 Apr 2015 (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 integrity of structural connectivity supporting cortical regions in the left brain hemisphere is hypothesized to enable treatment-induced naming recovery in persons with language difficulties after a stroke (aphasia). The investigators will map whole brain connectivity (i.e., the brain connectome) to investigate the role of cortical connectivity in impairment (Aim 1) and recovery (Aim 2) in patients with aphasia undergoing treatment. This information will be used to construct personalized markers of anomia treatment outcome (Aim 3), which may serve as a guide for speech-language pathologists and neurologists when facing patient management decisions.
Detailed description
Aphasia, an impairment of language processing, is one of the most common consequences of strokes affecting the dominant brain hemisphere4. Patients with aphasia are usually incapable of working, and their interactions with family and friends are often severely affected. The hallmark deficit of aphasia is the inability to name objects or people (anomia)12. The severity of anomia is closely related to a poor quality of life.
While many patients with aphasia exhibit some language recovery in the first days to weeks after the stroke, 30-40% persist with long lasting naming impairments4. Fortunately, speech therapy can be very effective to improve naming for some patients with chronic aphasia5-8. However, it is well recognized among clinicians that speech therapy can be ineffective for other patients, making it difficult to predict how and why some patients benefit from naming treatment, while others show little or no improvement.
Here, the investigators propose to evaluate whether naming impairment and naming recovery are related to the extent of structural damage to the cortical language network. Importantly, the investigators will evaluate damage as the combined effect of cortical necrosis and cortical disconnection. The investigators hypothesize that assessing anomia as being either due to gray matter necrosis or due to cortical disconnection constitutes a false dichotomy since most chronic patients exhibit gray and white matter damage. Furthermore, the investigators propose that disconnection of seemingly spared cortical areas has up till now been underappreciated in patients with stroke due to limitations in brain connectivity assessment tools. By examining only areas of cortical necrosis without considering disconnected areas, one may underestimate the magnitude of language network damage. A better understanding of the effects from both cortical damage and disconnection on anomia and its recovery could lead to an improved clinical management of aphasia.
The investigators will employ the innovative concept of the brain connectome, i.e., the individualized map of neural connections in the brain, to evaluate whether naming recovery is supported by preserved gray matter and preserved connectivity involving key language areas in the left hemisphere. The investigators propose that left frontal and left temporal connectivity mapped based on the individual's connectome is an important explanatory variable towards naming impairment and recovery.
The investigators believe that this research is significant for the three main reasons. First, it can have a direct clinical impact by providing a better understanding of which patients can benefit from therapy. Second, it can unveil the neurobiological mechanisms supporting language recovery, improving our understanding of brain plasticity related to language rehabilitation. Finally, if disconnection contributes to language impairment, our methods can be developed to test specific theories of language organization in the brain. The significance of these aspects is explained in detail below.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- No new patients will be recruited for the current project. We will rely solely on data collection in the tDCS-Trial (U01 DC011739, period 7/1/2012-6/31/2017). All information used in our experiments will be available as a result of the standardized set of tests that patients undergo in the trial.
Key inclusion criteria (10 listed)
- Patients must be willing and able to give informed consent.
- Patients must be willing and able to comply with study requirements.
- Patients must be between 25- and 80-years of age.
- Patients must be native English speakers.
- Patients must be pre-morbidly right-handed.
Key exclusion criteria (5 listed)
- History of brain surgery
- Seizures during the previous 12 months
- Sensitive scalp (per patient report)
- Able to overtly name more than an average of 140 out of 175 items during the pre-treatment picture naming test (Philadelphia Naming Test) during Visits 2 or 3.
- Unable to overtly name at least an average of 5 out of 80 items during the pre-treatment fMRI sessions during Visits 2 or 3.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Improvement in naming performance as assessed by the number of correctly spoken words after therapy
Time frame: 5 years
The primary outcome measure of this study is the objective improvement in the number of correctly spoken words after therapy. This study is also aimed at evaluating the neurological mechanisms (i.e., integrity of brain networks after stroke) that enable therapy-induced improvement.
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 14 May 2018.
Related trials for Aphasia
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Personalized Closed-Loop Brain Stimulation for Patients With Primary Progressive Aphasia
PPA
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Speech and Language Interventions for Italian People With PPA
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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.
Leonardo F Bonilha, MD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aphasia and Stroke, run by Medical University of South Carolina 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 10 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 14 May 2018. 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?
Improvement in naming performance as assessed by the number of correctly spoken words after therapy (time frame: 5 years). 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 14 May 2018.