Neural Bases of Vocal Sensorimotor Impairment in Aphasia
Primary Purpose
Aphasia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Visual Feedback Training
Sponsored by
About this trial
This is an interventional basic science trial for Aphasia
Eligibility Criteria
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.
Sites / Locations
- University of South CarolinaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Aphasia Group
Control Group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04742894
First Posted
February 3, 2021
Last Updated
May 8, 2023
Sponsor
University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT04742894
Brief Title
Neural Bases of Vocal Sensorimotor Impairment in Aphasia
Official Title
Neural Bases of Vocal Sensorimotor Impairment in Aphasia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2021 (Actual)
Primary Completion Date
February 28, 2026 (Anticipated)
Study Completion Date
February 28, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aphasia Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Visual Feedback Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Speech Production and Motor Control Ability
Description
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.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roozbeh Behroozmand, PhD
Phone
8037775055
Email
r-behroozmand@sc.edu
Facility Information:
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roozbeh Behroozmand, PhD
Phone
803-777-5055
Email
r-behroozmand@sc.edu
12. IPD Sharing Statement
Learn more about this trial
Neural Bases of Vocal Sensorimotor Impairment in Aphasia
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