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Neural Mechanisms for Stopping Ongoing Speech Production

Primary Purpose

Epilepsy, Speech

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Speech Production Tasks
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Epilepsy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Voice and Electrocorticography (ECoG) recording during Speech Production Tasks

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 11, 2023
Last Updated
October 13, 2023
Sponsor
University of California, San Francisco
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT05876910
Brief Title
Neural Mechanisms for Stopping Ongoing Speech Production
Official Title
Neural Mechanisms for Stopping Ongoing Speech Production
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 8, 2015 (Actual)
Primary Completion Date
November 30, 2027 (Anticipated)
Study Completion Date
November 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Speech

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Voice and Electrocorticography (ECoG) recording during Speech Production Tasks
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Speech Production Tasks
Intervention Description
View visual cues and undergo speech production for 30 minutes. Electrical stimulation of speech related brain regions in the middle of speech production.
Primary Outcome Measure Information:
Title
Mean Change in Neural Activity
Description
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.
Time Frame
During inpatient hospitalization, up to 14 days after surgical electrode implantation
Secondary Outcome Measure Information:
Title
Number of sites with stimulation induced speech termination
Description
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.
Time Frame
During inpatient hospitalization, up to 14 days after surgical electrode implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lingyun Zhao, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edward F Chang, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Chair
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Neural Mechanisms for Stopping Ongoing Speech Production

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