- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04742894
Neural Bases of Vocal Sensorimotor Impairment in Aphasia
April 22, 2024 updated by: Dr. Roozbeh Behroozmand, The University of Texas at Dallas
Aphasia is the most common type of post-stroke communication disorder characterized by deficits in speech comprehension, production and control.
While recovery can be promoted with speech therapy, improvement remains modest and typically requires a large number of sessions contributing to rising health care costs.
Traditional aphasia therapy focus on enhancing speech motor output; however, recent evidence suggests that the auditory feedback also plays a critical role in fluent speech.
Therefore, a key step toward refining treatment strategies is to develop objective biomarkers that can probe the integrity of sensorimotor mechanisms of speech auditory feedback and identify their impaired function in patients with post-stroke aphasia.
This study aims to examine the behavioral, neurophysiological (EEG), and neuroimaging (fMRI) biomarkers of speech impairment following stroke with focus on understanding the role of auditory feedback for speech production and control.
We plan to test individuals with post-stroke aphasia and a matched neuroptypical control group during different speech production tasks under the altered auditory feedback paradigm.
In addition, we aim to examine the effect of audio-visual feedback training on enhancing communication ability during speech.
These biomarkers will be combined with existing lesion-symptom-mapping data in the aphasic group in order to identify the patterns of brain damage and diminished structural connectivity within the auditory-motor areas of the left hemisphere that predict impaired sensorimotor processing of speech in aphasia.
The long-term goal of this research is to develop a model for identifying the source of sensorimotor deficit and improve diagnosis and targeted treatment of speech disorders in aphasia.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Roozbeh Behroozmand, PhD
- Phone Number: 9728833062
- Email: roozbeh.behroozmand@utdallas.edu
Study Locations
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Texas
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Richardson, Texas, United States, 75080
- The University of Texas at Dallas
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Contact:
- Roozbeh Behroozmand, PhD
- Phone Number: 972-883-3062
- Email: roozbeh.behroozmand@utdallas.edu
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- A total of 50 individuals with aphasia due to chronic left hemisphere stroke (> 6 months post-stroke) and 50 age- and gender-matched healthy control subjects will be recruited in this study. The general inclusion criteria for all subjects include: age range 21-75 years, right-handed, and native speaker of English. The aphasic subjects have previously undergone neuro-psychological speech/language testing and have been diagnosed with one type of aphasia (e.g., Broca's, Wernicke's, conduction or anomic). Subjects in the control group will meet the inclusion criteria with having normal voice, speech, language, and hearing function and no history of neurological and psychiatric disorder. We expect that a significant proportion of aphasic patients will show symptoms associated with Apraxia of Speech (AOS) or dysarthria; however, these patients will not be excluded unless their deficits will preclude them from performing the experimental tasks.
Exclusion Criteria:
- Subjects with moderate to severe hearing, memory, and/or cognitive impairments will be excluded for both groups. In addition, subjects with history of peripheral laryngeal disorders (e.g., paresis or vocal fold paralysis) will be excluded. Subjects will undergo safety screening and will be excluded if there are any factors counter-indicative for EEG and/or MRI scanning.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control Group
|
Participants will be trained to work with a computer setup to control the position of a visual cursor on the screen using their speech while their auditory feedback is altered.
The goal of the training is to help improve speech production and motor control ability.
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Experimental: Aphasia Group
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Participants will be trained to work with a computer setup to control the position of a visual cursor on the screen using their speech while their auditory feedback is altered.
The goal of the training is to help improve speech production and motor control ability.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Speech Production and Motor Control Ability
Time Frame: 2 weeks
|
Participants accuracy in using their speech for controlling the visual cursor will be assessed via measuring their deviation from hitting a pre-defined target on the screen.
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2 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2024
Primary Completion (Estimated)
February 28, 2026
Study Completion (Estimated)
February 28, 2026
Study Registration Dates
First Submitted
February 3, 2021
First Submitted That Met QC Criteria
February 3, 2021
First Posted (Actual)
February 8, 2021
Study Record Updates
Last Update Posted (Estimated)
April 24, 2024
Last Update Submitted That Met QC Criteria
April 22, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-24-325
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Aphasia
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University of South CarolinaNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedStroke | Aphasia | Stroke, Ischemic | Aphasia, Broca | Aphasia, Anomic | Aphasia, Global | Aphasia, Fluent | Aphasia, Mixed | Aphasia, Jargon | Aphasia, Expressive | Aphasia, ConductionUnited States
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University of Texas at AustinUniversity of California, San Francisco; National Institute on Deafness and...Active, not recruitingPrimary Progressive Aphasia | Aphasia | Semantic Dementia | Logopenic Progressive Aphasia | Semantic Memory Disorder | Nonfluent Aphasia, Progressive | Aphasia, ProgressiveUnited States
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Institute for Bioengineering of CataloniaHospital Universitari Joan XXIII de Tarragona.; Universitat Pompeu FabraCompletedAphasia | Aphasia, Broca | Aphasia, Wernicke | Aphasia, Fluent | Aphasia, NonfluentSpain
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Flint Rehabilitation Devices, LLCUniversity of TexasCompleted
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Mayo ClinicNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingPrimary Progressive Aphasia | Apraxia of Speech | PPA | Non-fluent Aphasia | Primary Progressive Non-fluent AphasiaUnited States
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University of California, BerkeleyUniversity of California, San Francisco; California State University, East Bay and other collaboratorsRecruitingAphasia | Aphasia, Acquired | Aphasia Non Fluent | Aphasia, FluentUnited States
-
Mayo ClinicCompletedPrimary Progressive Aphasia | Aphasia | Semantic Dementia | Apraxia of Speech | Primary Progressive Nonfluent Aphasia | PPA | Non-fluent Aphasia | Progressive AphasiaUnited States
-
Montreal Heart InstituteActive, not recruitingNeurodegenerative Diseases | Primary Progressive Aphasia | Semantic Dementia | Logopenic Progressive Aphasia | Non-fluent AphasiaCanada
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Johns Hopkins UniversityNational Institute on Aging (NIA)RecruitingPrimary Progressive Aphasia | Logopenic Progressive Aphasia | Non-Fluent Primary Progressive AphasiaUnited States, Canada
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University of British ColumbiaTerminatedPrimary Progressive Nonfluent AphasiaCanada
Clinical Trials on Visual Feedback Training
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Hugo W. Moser Research Institute at Kennedy Krieger...Eunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruiting
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Shirley Ryan AbilityLabSuspended
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National Yang Ming UniversityNot yet recruitingStroke Syndrome
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Taipei Medical University HospitalCompleted
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Texas Christian UniversityEnrolling by invitation
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Aveiro UniversityCompleted
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Hugo W. Moser Research Institute at Kennedy Krieger...National Institute of Neurological Disorders and Stroke (NINDS); National Institutes...Recruiting
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Riphah International UniversityRecruiting
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University of British ColumbiaNatural Sciences and Engineering Research Council, Canada; Networks of Centres... and other collaboratorsCompleted