Clinical trial NCT04989309: Left and Right Hemisphere Contributions to Speech Perception
Official title: The Role of Frontal and Temporal Brain Areas in the Perception of Phonetic Category Structure
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Neural Bases of Speech Perception
Keywords: Speech perception
Left temporal lobe
Right temporal lobe
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2021-08-04
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will receive blocks of stimulation at the left temporal lobe, right temporal lobe, and vertex, with the order of stimulation counterbalanced across participants (a crossover design). All analysis is within-subject.

Participants in each arm will hear different types of speech stimuli, which allows for the assessment of the effect of stimulation at different stimulation sites on processing that specific aspect of the speech signal.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

This 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Categorization accuracy
timeFrame: Immediately following the stimulation pulses (within one second of the final pulse).
measure: Two-alternative forced choice accuracy
timeFrame: Immediately following the stimulation pulses (within one second of the final pulse).
measure: Two-alternative forced choice reaction time
timeFrame: Immediately following the stimulation pulses (within one second of the final pulse).
Secondary outcomes:
Other outcomes:
Locations:
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
Study officials:
References:
citation: 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/jocn_a_01521. Epub 2020 Jan 14.
citation: 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/j.clinph.2020.10.003. Epub 2020 Oct 24.