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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05876910
Other study ID # K99DC020235
Secondary ID K99DC020235
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date December 8, 2015
Est. completion date November 30, 2027

Study information

Verified date October 2023
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 30
Est. completion date November 30, 2027
Est. primary completion date November 30, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Speech Production Tasks
View visual cues and undergo speech production for 30 minutes. Electrical stimulation of speech related brain regions in the middle of speech production.

Locations

Country Name City State
United States University of California, San Francisco San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Francisco National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Change in Neural Activity 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. During inpatient hospitalization, up to 14 days after surgical electrode implantation
Secondary Number of sites with stimulation induced speech termination 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. During inpatient hospitalization, up to 14 days after surgical electrode implantation
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