EpilepsyNCT05876910
Neural Mechanisms for Stopping Ongoing Speech Production
A study testing Speech Production Tasks in people with Epilepsy and Speech, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Speech Production Tasks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2015to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants who lack capacity,
- Participants who decline to provide informed consent or
- Participants with cognitive deficits that preclude reliable completion of study tasks.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
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.
Read the 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.
- Being tested
- Speech Production Tasks
- Medical subject headings
- Epilepsy, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech Production TasksBehavioural
View visual cues and undergo speech production for 30 minutes. Electrical stimulation of speech related brain regions in the middle of speech production.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Speech Production Tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During inpatient hospitalization, up to 14 days after surgical electrode implantation
Secondary outcomes (1)
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.
Measured: During inpatient hospitalization, up to 14 days after surgical electrode implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start8 Dec 2015
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Lingyun Zhao, PhD, Principal investigator, University of California, San FranciscoEdward F Chang, MD, Study chair, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876910
- Sponsor's protocol ID
- K99DC020235
- Other IDs
- K99DC020235
- Status last verified
- Oct 2024
- First submitted
- 11 May 2023
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms for Stopping Ongoing Speech Production
- ClinicalTrials.gov ID
- NCT05876910
- Acronym / sponsor ID
- K99DC020235
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 8 Dec 2015 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Voice and Electrocorticography (ECoG) recording during Speech Production Tasks | Experimental | Behavioral: Speech Production TasksParticipants 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Participants who lack capacity,
- Participants who decline to provide informed consent or
- Participants with cognitive deficits that preclude reliable completion of study tasks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speech Production TasksView visual cues and undergo speech production for 30 minutes. Electrical stimulation of speech related brain regions in the middle of speech production. | Behavioural | Voice and Electrocorticography (ECoG) recording during Speech Production Tasks |
Primary outcome
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.
1 secondary outcome
Number of sites with stimulation induced speech termination
Time frame: During inpatient hospitalization, up to 14 days after surgical electrode implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lingyun Zhao, PhD principal investigator
University of California, San Francisco
Edward F Chang, MD study chair
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speech Production Tasks in people with Epilepsy and Speech, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Neural Activity (time frame: During inpatient hospitalization, up to 14 days after surgical electrode implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.