NCT05876910

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
19mo left

Started Dec 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Dec 2015Nov 2027

Study Start

First participant enrolled

December 8, 2015

Completed
7.4 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

12 years

First QC Date

May 11, 2023

Last Update Submit

October 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of sites with stimulation induced speech termination

    During inpatient hospitalization, up to 14 days after surgical electrode implantation

Study Arms (1)

Voice and Electrocorticography (ECoG) recording during Speech Production Tasks

EXPERIMENTAL

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).

Behavioral: Speech Production Tasks

Interventions

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

Voice and Electrocorticography (ECoG) recording during Speech Production Tasks

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Participants who lack capacity,
  • Participants who decline to provide informed consent or
  • Participants with cognitive deficits that preclude reliable completion of study tasks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

EpilepsySpeech

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVerbal BehaviorCommunicationBehavior

Study Officials

  • Lingyun Zhao, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR
  • Edward F Chang, MD

    University of California, San Francisco

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2023

First Posted

May 26, 2023

Study Start

December 8, 2015

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2027

Last Updated

October 8, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations