[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04989309":3,"trial-entities:NCT04989309":104,"trial-summary:NCT04989309":108},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":40,"secondary_outcomes":51,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":55,"eligibility_criteria":56,"std_ages":81,"locations":84,"central_contacts":93,"overall_officials":94,"references":95,"see_also_links":103},"NCT04989309","H21-0046","Left and Right Hemisphere Contributions to Speech Perception","The Role of Frontal and Temporal Brain Areas in the Perception of Phonetic Category Structure","ENROLLING_BY_INVITATION","2026-06-30","2024-12","2025-06-15","2024-12-19","University of Connecticut","OTHER",false,"Left and right temporal brain areas are thought to contribute to speech perception, but the division of labor between left and right hemisphere regions is still unclear. Here we use transcranial magnetic stimulation (TMS) to stimulate left and right temporal foci and a vertex control site to temporarily disrupt activation at the stimulation site, using a \"virtual lesion\" approach to test the effect of stimulation site on a series of speech perception tasks.\n\nThis portion of the project is basic research. However, since TMS is viewed as an intervention, studies involving TMS in this grant are considered clinical trials.","This study uses TMS to temporarily disrupt neural activity in the left and right temporal cortex and examine the effect of this disruption on speech perception tasks. Vertex stimulation is included as a control condition against which left and right superior temporal stimulation effects are compared. Adult participants first undergo structural MRI and a speech localizer using functional MRI to identify speech-sensitive voxels in the left and right temporal cortex. These regions are set by-participant as the foci for stimulation. Stimulation site is blocked, and typically distributed across sessions. 10 Hz pulse trains of 2.5 sec each are delivered to the stimulation site, with an auditory stimulus arriving either immediately after the last pulse (Exps 2 and 6) or, for longer sentence level stimuli (Exp 3), during the pulse train. Behavioral measures include accuracy and reaction times to rate phonetic stimuli (Exp 2), detect the presence of a probe word in the preceding sentence (Exp 3), or categorize stimuli by phonetic contrast and talker (Exp 6).",[19],"Neural Bases of Speech Perception",[21,22,23],"Speech perception","Left temporal lobe","Right temporal lobe","INTERVENTIONAL","BASIC_SCIENCE",[27],"NA",{"count":29,"type":30},26,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DEVICE","Transcranial Magnetic Stimulation","TMS will be delivered in 10 Hz pulses for 2.5 seconds, with behavioral measures of speech perception and object categorization immediately following each pulse. TMS at this schedule is thought to temporarily disrupt activity at the stimulation site.",[37,38,39],"Experiment 2. Phonetic precision disrupted by TMS","Experiment 3. Phonetic ambiguity in continuous speech","Experiment 6: Disruption of talker-specific phonetic learning using TMS.",[41,45,48],{"measure":42,"description":43,"timeFrame":44},"Categorization accuracy","Participants categorize items which vary along a perceptual continuum. Steepness of the categorization curve is extracted to estimate categorization accuracy.","Immediately following the stimulation pulses (within one second of the final pulse).",{"measure":46,"description":47,"timeFrame":44},"Two-alternative forced choice accuracy","Participants are given two options and asked to indicate which item they heard in the previous signal. Accuracy in making this decision is a primary outcome measure.",{"measure":49,"description":50,"timeFrame":44},"Two-alternative forced choice reaction time","Participants are given two options and asked to indicate which item they heard in the previous signal. Reaction time to make this decision is a primary outcome measure.",[],"ALL","18 Years",null,true,{"inclusion":57,"exclusion":63,"raw_text":80},[58,59,60,61,62],"Monolingual native speaker of English","No history of neurological impairments or disease","Free of speech and language disorders (per self-report, and confirmed by short language battery described by Fidler, Vance, \\& Plante, 2011)","Pure-tone thresholds of 30 decibels or better in both ears (no worse than mild hearing loss), with no more than 15 dB between-ear difference.","Right-handed, as confirmed by Oldfield Handedness Inventory",[64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79],"Any condition where TMS would be contraindicated according to the most recent guidelines, including, but not limited to:","History of seizure or epilepsy","Metal in the skull","Use of legal or illicit drugs that can potentially reduce the threshold for seizure. As examples, we list some exclusionary drugs in each of the following categories. This is not an exhaustive list of the exclusionary drugs. We consult with faculty in the University of Connecticut College of Pharmacy to check for seizure risk with other drugs that participants report.","Antidepressants including Imipramine, amitriptyline, sertraline, venlafaxine, buproprion","Antipsychotics including Chlorpromazine, clozapine, haloperidol, aripiprazole","Antivirals including foscarnet, ganciclovir","Antiparasitics including chloroquine, mefloquine (antiparasitics)","Antibiotics including penicillin, ampicillin","Immunosuppressants including cyclosporin","Anticholinergenics","Antihistimines (including over-the-counter drugs like Claritin \\& Benadryl)","Sympathomimetics (including Sudafed, Ritalin).","Illegal drugs such as methamphetamines, cocaine, MDMA, ketamine.","Diagnosis of a psychiatric disorder (per self-report)","Pregnancy","Inclusion Criteria:\n\n* Monolingual native speaker of English\n* No history of neurological impairments or disease\n* Free of speech and language disorders (per self-report, and confirmed by short language battery described by Fidler, Vance, \\& Plante, 2011)\n* Pure-tone thresholds of 30 decibels or better in both ears (no worse than mild hearing loss), with no more than 15 dB between-ear difference.\n* Right-handed, as confirmed by Oldfield Handedness Inventory\n\nExclusion Criteria:\n\n* Any condition where TMS would be contraindicated according to the most recent guidelines, including, but not limited to:\n\n  * History of seizure or epilepsy\n  * Metal in the skull\n  * Use of legal or illicit drugs that can potentially reduce the threshold for seizure. As examples, we list some exclusionary drugs in each of the following categories. This is not an exhaustive list of the exclusionary drugs. We consult with faculty in the University of Connecticut College of Pharmacy to check for seizure risk with other drugs that participants report.\n\n    * Antidepressants including Imipramine, amitriptyline, sertraline, venlafaxine, buproprion\n    * Antipsychotics including Chlorpromazine, clozapine, haloperidol, aripiprazole\n    * Antivirals including foscarnet, ganciclovir\n    * Antiparasitics including chloroquine, mefloquine (antiparasitics)\n    * Antibiotics including penicillin, ampicillin\n    * Immunosuppressants including cyclosporin\n    * Anticholinergenics\n    * Antihistimines (including over-the-counter drugs like Claritin \\& Benadryl)\n    * Sympathomimetics (including Sudafed, Ritalin).\n    * Illegal drugs such as methamphetamines, cocaine, MDMA, ketamine.\n  * Diagnosis of a psychiatric disorder (per self-report)\n  * Pregnancy",[82,83],"ADULT","OLDER_ADULT",[85],{"facility":13,"city":86,"state":87,"zip":88,"country":89,"geoPoint":90},"Storrs","Connecticut","06268","United States",{"lat":91,"lon":92},41.80843,-72.24952,[],[],[96,100],{"pmid":97,"type":98,"citation":99},"31933438","BACKGROUND","Kennedy-Higgins D, Devlin JT, Nuttall HE, Adank P. The Causal Role of Left and Right Superior Temporal Gyri in Speech Perception in Noise: A Transcranial Magnetic Stimulation Study. J Cogn Neurosci. 2020 Jun;32(6):1092-1103. doi: 10.1162\u002Fjocn_a_01521. Epub 2020 Jan 14.",{"pmid":101,"type":98,"citation":102},"33243615","Rossi S, Antal A, Bestmann S, Bikson M, Brewer C, Brockmoller J, Carpenter LL, Cincotta M, Chen R, Daskalakis JD, Di Lazzaro V, Fox MD, George MS, Gilbert D, Kimiskidis VK, Koch G, Ilmoniemi RJ, Lefaucheur JP, Leocani L, Lisanby SH, Miniussi C, Padberg F, Pascual-Leone A, Paulus W, Peterchev AV, Quartarone A, Rotenberg A, Rothwell J, Rossini PM, Santarnecchi E, Shafi MM, Siebner HR, Ugawa Y, Wassermann EM, Zangen A, Ziemann U, Hallett M; basis of this article began with a Consensus Statement from the IFCN Workshop on \"Present, Future of TMS: Safety, Ethical Guidelines\", Siena, October 17-20, 2018, updating through April 2020. Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines. Clin Neurophysiol. 2021 Jan;132(1):269-306. doi: 10.1016\u002Fj.clinph.2020.10.003. Epub 2020 Oct 24.",[],{"nct_id":4,"conditions":105,"biomarkers":107},[106],"Speech Perception",[],{"nct_id":4,"found":15,"summary":54,"prompt_version":54}]