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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04742894
Other study ID # IRB-24-325
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date February 28, 2026

Study information

Verified date April 2024
Source The University of Texas at Dallas
Contact Roozbeh Behroozmand, PhD
Phone 9728833062
Email roozbeh.behroozmand@utdallas.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date February 28, 2026
Est. primary completion date February 28, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Visual Feedback Training
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.

Locations

Country Name City State
United States University of South Carolina Columbia South Carolina
United States University of California Irvine Irvine California
United States The University of Texas at Dallas Richardson Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas at Dallas

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Speech Production and Motor Control Ability 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. 2 weeks
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