NCT04989309

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Dec 2024Jun 2026

First Submitted

Initial submission to the registry

July 6, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 4, 2021

Completed
3.4 years until next milestone

Study Start

First participant enrolled

December 19, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

June 15, 2025

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

July 6, 2021

Last Update Submit

June 11, 2025

Conditions

Keywords

Speech perceptionLeft temporal lobeRight temporal lobe

Outcome Measures

Primary Outcomes (3)

  • 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).

  • 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.

    Immediately following the stimulation pulses (within one second of the final pulse).

  • 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.

    Immediately following the stimulation pulses (within one second of the final pulse).

Study Arms (3)

Experiment 2. Phonetic precision disrupted by TMS

EXPERIMENTAL

Experiment 2 tests the influence of temporary disruption of activity within the left or right temporal cortex on the speed and precision of phonetic decisions compared to vertex stimulation. Participants will receive stimulation at all three sites (left temporal, right temporal, vertex, with order of stimulation counterbalanced across participants). Immediately following stimulation pulses, participants will perform a visual analog scale (VAS) phonetic rating task on tokens from the four continua, embedded in speech-shaped noise. To control for the possibility that TMS leads to a generalized deficit in categorization, a control task will involve categorization of visual objects on a morphed "dog" to "cat" object continuum. (We expect this task to be unaffected by TMS). The variables of interest are the steepness of the categorization curve, mean reaction time to all items on the continuum, and the difference in reaction time for boundary vs. endpoint tokens.

Device: Transcranial Magnetic Stimulation

Experiment 3. Phonetic ambiguity in continuous speech

EXPERIMENTAL

Experiment 3 is designed to test whether left vs. right temporal lobe stimulation selectively disrupts processing of naturally-occurring phonetic ambiguity as compared to vertex stimulation (control). Participants will receive stimulation at all three sites (left temporal, right temporal, vertex, with order of stimulation counterbalanced across participants). Stimuli will be nonsense sentences produced clearly or in a casual register. By-sentence phonetic ambiguity is estimated by the proximity of each token to other vowels belonging to different categories. Sentences will be embedded in speech-shaped noise to increase difficulty. Participants will listen to each sentence, then respond whether a visually-presented probe word appeared in the sentence ("BRASS?"). Dependent variables are accuracy and reaction time on this probe verification task.

Device: Transcranial Magnetic Stimulation

Experiment 6: Disruption of talker-specific phonetic learning using TMS.

EXPERIMENTAL

Experiment 6 is designed to test whether disruption of activity in left or right temporal regions (vs. vertex control) using TMS interferes with talker-specific learning. Participants will receive stimulation at all three sites (left temporal, right temporal, vertex, with order of stimulation counterbalanced across participants). The study uses a training paradigm where one talker's speech is manipulated to always have relatively short voice onset times (VOTs) for voiceless stops (e.g., /k/ in "coal") and another to have relatively long VOTs. Immediately after stimulation, listeners will undergo a training trial where they identify sounds as mapping to Talker 1 or Talker 2's voice, and to the word (e.g. "gain" vs. "cane"). At test, listeners hear two VOT variants and are asked which is more typical of that talker's speech. The dependent variable is the accuracy of reporting which variant is typical of the talker.

Device: Transcranial Magnetic Stimulation

Interventions

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.

Experiment 2. Phonetic precision disrupted by TMSExperiment 3. Phonetic ambiguity in continuous speechExperiment 6: Disruption of talker-specific phonetic learning using TMS.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06268, United States

Location

Related Publications (2)

  • 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.

    PMID: 31933438BACKGROUND
  • 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.

    PMID: 33243615BACKGROUND

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will receive stimulation at different sites (left and right temporal areas, vertex control), and may be aware of the location of placement of the TMS coil, so in a strict sense participants cannot be fully unaware of the stimulation site.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 6, 2021

First Posted

August 4, 2021

Study Start

December 19, 2024

Primary Completion

December 31, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

June 15, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

Results of these studies will be used for teaching, research publications, and presentation at scientific meetings. De-identified raw data of all types (behavioral, MRI) will be available upon request after publication. MRI data will be processed ("skull stripped") to remove any identifiable anatomy before archival. We will archive data locally using Brain Imaging Data Structure (BIDS) naming conventions to facilitate data sharing. We plan to pre-register behavioral studies on the Open Science Framework (or similar platforms), and in the interests of scientific transparency, we will post de-identified behavioral data and analysis code on Open Science Framework or GitHub.

Shared Documents
SAP, ANALYTIC CODE
Time Frame
We will share data and code upon publication, and de-identified data will be available indefinitely.
Access Criteria
Open

Locations