- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03416738
Modeling Treated Recovery From Aphasia
(C-STAR) Center for the Study of Aphasia Recovery Modeling Treated Recovery From Aphasia
Stroke is the leading cause of adult disability in the United States, and aphasia is common following a stroke to the left hemisphere of the brain. Aphasia therapy can improve aphasia recover; however, very little is known about how different patients respond to different types of treatments.
The purpose of this study is to understand how the following factors influence an individual's response to aphasia treatment: 1) biographical factors (e.g., age, education, gender), 2) post-stroke cognitive/linguistic abilities and learning potential, and 3) the location and extent of post-stroke brain damage. We are also interested in understanding the kinds of treatment materials that should be emphasized in speech/language treatment.
Overall, the goal of the current research is to inform the clinical management of post-stroke aphasia by identifying factors that can predict how an individual will respond to different treatment methods.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Columbia, South Carolina, United States, 29208
- University of South Carolina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Experienced a left hemisphere ischemic or hemorrhagic stroke At least 12 months post-stroke
- Primarily English speaker for the past 20 years
- Ability to provide informed written or verbal consent MRI-compatible (e.g., no metal implants, not claustrophobic)
Exclusion Criteria:
- History of a right hemisphere stroke (Bilateral stroke)
- Clinically reported history of dementia, alcohol abuse, psychiatric disorder, traumatic brain injury, or extensive visual acuity or visual-spatial problems
- Severely limited speech production and/or auditory comprehension that interferes with adequate participation in the therapy provided
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Semantically focused treatment
This treatment will focus on improving word finding and comprehension of information.
|
Tasks are as follows:
These are tasks used in clinical aphasia rehabilitation. |
|
ACTIVE_COMPARATOR: Phonologically focused treatment
This treatment will focus on training speech sound production, targeting overall production abilities.
|
Tasks are as follows:
These are tasks used in clinical aphasia rehabilitation. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Philadelphia Naming Test
Time Frame: 6 months
|
Assesses the ability to name functional objects
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julius Fridriksson, PhD, CCC-SLP, University of South Carolina
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
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
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Language Disorders
- Communication Disorders
- Speech Disorders
- Stroke
- Ischemic Stroke
- Aphasia
- Anomia
- Aphasia, Broca
- Aphasia, Wernicke
- Aphasia, Conduction
Other Study ID Numbers
- Pro00053559
- P50DC014664 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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