- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05876910
Neural Mechanisms for Stopping Ongoing Speech Production
October 3, 2024 updated by: University of California, San Francisco
Speech and communication disorders often result in aberrant control of the timing of speech production, such as making improper stops at places where they should not be.
During normal speech, the ability to stop when necessary is important for maintaining turn-taking in a smooth conversation.
Existing studies have largely investigated neural circuits that support the preparation and generation of speech sounds.
It is believed that activity in the prefrontal and premotor cortical areas facilitates high-level speech control and activity in the ventral part of the sensorimotor cortex controls the articulator (e.g.
lip, jaw, tongue) movements.
However, little is known about the neural mechanism controlling a sudden and voluntary stop of speech.
Traditional view attributes this to a disengagement of motor signals while recent evidence suggested there may be an inhibitory control mechanism.
This gap in knowledge limits our understanding of disorders like stuttering and aphasia, where deficits in speech timing control are among the common symptoms.
The overall goal of this study is to determine how the brain controls the stopping of ongoing speech production to deepen our understanding of speech and communication in normal and impaired conditions.
Study Overview
Status
Enrolling by invitation
Intervention / Treatment
Detailed Description
High-density electrocorticography (ECoG) is a state-of-the-art technique with fine spatial and temporal resolutions that are well suited for studying the neural dynamics of speech.
This study proposes to assess speech production in patients who are undergoing high-density ECoG recording to carry out clinical procedures for indications related to their medical condition.
The research study team will investigate neural signals correlated with speech stopping using speech production and stopping tasks with visual cues.
Electrical stimulation routinely used for language mapping will also be applied to test the causal effect on speech behavior in brain areas found to be activated during the speech tasks.
The research study team will compare effects on neural activity and behavior within each individual subject and identify common patterns of activity across subjects.
The aims of this study seek to define the premotor signal for the control of speech stopping (Aim 1), determine the effect of stop activity on articulatory control during stopping (Aim 2), and determine the role of the premotor network for stopping in conversation contexts (Aim 3).
These aims will provide basic knowledge for the precise control of speech stopping and the control of speech timing in general, bridging the current speech production studies to real-world communication conditions, and help inspire new theories of speech motor control.
Study Type
Interventional
Enrollment (Estimated)
30
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 Locations
-
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California
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San Francisco, California, United States, 94143
- University of California, San Francisco
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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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Participants with medication refractory epilepsy at UCSF undergoing surgical electrode implantation of subdural electrode arrays to define their seizure focus and
- Participants with electrodes implanted who are willing and able to cooperate with study tasks.
Exclusion Criteria:
- Participants who lack capacity,
- Participants who decline to provide informed consent or
- Participants with cognitive deficits that preclude reliable completion of study tasks.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Voice and Electrocorticography (ECoG) recording during Speech Production Tasks
Participants produce speech following visual cues on a computer while ECoG signals for neural activity and voice was recorded during their inpatient hospitalization at the University of California, San Francisco (UCSF).
|
View visual cues and undergo speech production for 30 minutes.
Electrical stimulation of speech related brain regions in the middle of speech production.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Change in Neural Activity
Time Frame: During inpatient hospitalization, up to 14 days after surgical electrode implantation
|
The mean change in neural activity is calculated as the average change in neural activity across trials between a time period (~1 second) after the visual cue and a time period (~1 second) before the visual cue.
Included neural activity is within the 30-minute period of cue viewing and speech production tasks.
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During inpatient hospitalization, up to 14 days after surgical electrode implantation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of sites with stimulation induced speech termination
Time Frame: During inpatient hospitalization, up to 14 days after surgical electrode implantation
|
The sites with stimulation induced speech termination are defined as the stimulation sites where termination of speech production (occurrence) is observed within 10 seconds after the electrical stimulation.
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During inpatient hospitalization, up to 14 days after surgical electrode implantation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lingyun Zhao, PhD, University of California, San Francisco
- Study Chair: Edward F Chang, MD, University of California, San Francisco
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 (Actual)
December 8, 2015
Primary Completion (Estimated)
November 30, 2027
Study Completion (Estimated)
November 30, 2027
Study Registration Dates
First Submitted
May 11, 2023
First Submitted That Met QC Criteria
May 23, 2023
First Posted (Actual)
May 26, 2023
Study Record Updates
Last Update Posted (Actual)
October 8, 2024
Last Update Submitted That Met QC Criteria
October 3, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K99DC020235 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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