[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07713706":3,"trial-entities:NCT07713706":77,"trial-summary:NCT07713706":82},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":40,"sex":41,"minimum_age":42,"maximum_age":43,"healthy_volunteers":14,"eligibility_criteria":44,"std_ages":56,"locations":59,"central_contacts":69,"overall_officials":70,"references":75,"see_also_links":76},"NCT07713706","STUDY25040153","Neural Mechanisms for Stopping Ongoing Speech Production (Study 2)","ENROLLING_BY_INVITATION","2028-07-31","2026-07","2026-07-20","2026-09-01","Lingyun Zhao","OTHER",false,"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.","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.",[18,19],"Epilepsy","Speech",[],"INTERVENTIONAL","BASIC_SCIENCE",[24],"NA",{"count":26,"type":27},12,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","Speech Production Tasks","View visual cues and undergo speech production.",[34],"Voice and iEEG recording during Speech Production Tasks",[36],{"measure":37,"description":38,"timeFrame":39},"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.","During inpatient hospitalization, up to 14 days after surgical electrode implantation",[],"ALL","8 Years","26 Years",{"inclusion":45,"exclusion":50,"raw_text":55},[46,47,48,49],"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",[51,52,53,54],"Individuals with intellectual disability","Lack of fluent English comprehension\u002Fproduction","Inadequate speech ability for the research tasks.","History of autism or ADHD","Inclusion Criteria:\n\n* 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\n* Fluent English speakers\n* Within the normal range for cognitive, speech-language, and hearing capacity\n* Normal or corrected-to-normal visual acuity\n\nExclusion Criteria:\n\n* Individuals with intellectual disability\n* Lack of fluent English comprehension\u002Fproduction\n* Inadequate speech ability for the research tasks.\n* History of autism or ADHD",[57,58],"CHILD","ADULT",[60],{"facility":61,"city":62,"state":63,"zip":64,"country":65,"geoPoint":66},"UPMC Children's Hospital of Pittsburgh","Pittsburgh","Pennsylvania","15224","United States",{"lat":67,"lon":68},40.44062,-79.99589,[],[71],{"name":72,"affiliation":73,"role":74},"Lingyun Zhao, PhD","University of Pittsburgh","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":78,"biomarkers":81},[79,80],"Seizure Disorder","Speech and Communication Disorders",[],{"nct_id":4,"found":83,"summary":84,"prompt_version":94},true,{"design":85,"status":86,"heading":87,"summary":88,"follow_up":89,"word_count":90,"commitments":91,"compensation":92,"drugs_mentioned":93},"This is an interventional study with a planned enrollment of 12 participants. It is not specified if it's randomized or blinded.","completed","Understanding Speech Stopping in Epilepsy Patients","This study, called \"Neural Mechanisms for Stopping Ongoing Speech Production (Study 2),\" is looking for 12 participants aged 8 to 26 years old who have epilepsy and are already scheduled to have iEEG (intracranial electroencephalography) electrodes placed in their brain for clinical reasons. The study wants to understand how the brain stops speech. You would perform \"Speech Production Tasks\" where you see visual cues and speak. Researchers will measure changes in your brain activity during these tasks to see how your brain controls stopping speech. This will happen during your hospital stay, up to 14 days after your electrodes are put in. The study is currently unclear about its status.","Brain activity will be measured during inpatient hospitalization, up to 14 days after surgical electrode implantation.",110,"You would participate in speech production tasks while iEEG recordings are being taken. This occurs during your inpatient hospitalization, up to 14 days after surgical electrode implantation.","Not stated in the trial record.",[31],"v2"]