EpilepsyNCT07713706
Neural Mechanisms for Stopping Ongoing Speech Production (Study 2)
A study testing Speech Production Tasks in people with Epilepsy and Speech, run by Lingyun Zhao 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 8 to 26 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
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 31 Jul 2028
- 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 8 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Undergoing iEEG placement in regions of interest (e.g., in the frontal or temporal cortex) for clinically necessary localization of epileptic foci or language mapping
- Fluent English speakers
- Within the normal range for cognitive, speech-language, and hearing capacity
- Normal or corrected-to-normal visual acuity
Who cannot join
- Individuals with intellectual disability
- Lack of fluent English comprehension/production
- Inadequate speech ability for the research tasks.
- History of autism or ADHD
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
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
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
Intracranial electroencephalography (iEEG) 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 iEEG 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. The research study team will compare effects on neural activity within each individual subject and identify common patterns of activity across subjects. The aims of this study seek to determine the role of the premotor network for stopping during naturalistic usage. This study 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.
| Study group | Role | What they receive |
|---|---|---|
| Voice and iEEG recording during Speech Production Tasks | Experimental | Not described 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
Neural signal recorded at each electrode (measured in voltage) is bandpass-filtered and converted to analytic amplitude using Hilbert transform, and then Z-scored relative to the entire recording block period for that electrode. A Z-score of 0 represents the mean neural activity within the recording block period, during which the task is performed. A positive Z-score indicates higher neural activity compared to the block mean. The mean change in neural activity was calculated as the difference between the average Z-score in two time windows (~1 second after the visual cue vs. ~1 second before), averaged across trials for each electrode and then across electrodes from all participants. Positive values of the mean change in neural activity indicate that neural activity was increased after the visual cue. Since the Z-score used here is a normalized neurophysiological measure rather than a clinical scale, there are no established thresholds or definitions of better or worse outcomes.
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 posted20 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (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.
- 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lingyun Zhao
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor-investigator, Lingyun Zhao, University of Pittsburgh
- Investigators
- Lingyun Zhao, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713706
- Sponsor's protocol ID
- STUDY25040153
- Other IDs
- R00DC020235
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to privacy concerns associated with intracranial data.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms for Stopping Ongoing Speech Production (Study 2)
- ClinicalTrials.gov ID
- NCT07713706
- Acronym / sponsor ID
- STUDY25040153
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Lingyun ZhaoUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 20 Jul 2026 (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
Intracranial electroencephalography (iEEG) 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 iEEG 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. The research study team will compare effects on neural activity within each individual subject and identify common patterns of activity across subjects. The aims of this study seek to determine the role of the premotor network for stopping during naturalistic usage. This study 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 iEEG recording during Speech Production Tasks | Experimental | Behavioral: Speech Production Tasks |
Who may qualify
- Ages
- 8 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Undergoing iEEG placement in regions of interest (e.g., in the frontal or temporal cortex) for clinically necessary localization of epileptic foci or language mapping
- Fluent English speakers
- Within the normal range for cognitive, speech-language, and hearing capacity
- Normal or corrected-to-normal visual acuity
Key exclusion criteria (4 listed)
- Individuals with intellectual disability
- Lack of fluent English comprehension/production
- Inadequate speech ability for the research tasks.
- History of autism or ADHD
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. | Behavioural | Voice and iEEG 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
Neural signal recorded at each electrode (measured in voltage) is bandpass-filtered and converted to analytic amplitude using Hilbert transform, and then Z-scored relative to the entire recording block period for that electrode. A Z-score of 0 represents the mean neural activity within the recording block period, during which the task is performed. A positive Z-score indicates higher neural activity compared to the block mean. The mean change in neural activity was calculated as the difference between the average Z-score in two time windows (~1 second after the visual cue vs. ~1 second before), averaged across trials for each electrode and then across electrodes from all participants. Positive values of the mean change in neural activity indicate that neural activity was increased after the visual cue. Since the Z-score used here is a normalized neurophysiological measure rather than a clinical scale, there are no established thresholds or definitions of better or worse outcomes.
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 20 Jul 2026.
- Individual participant dataSharing planned: No. IPD will not be shared due to privacy concerns associated with intracranial data.
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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 Pittsburgh
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 Lingyun Zhao 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 4 inclusion and 4 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 20 Jul 2026. 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 20 Jul 2026.