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Completed

NCT Number: NCT05723575

Modulation of Sensory Acuity With Transcranial Magnetic Stimulation (TMS)

The purpose of this research study is to understand how the brain processes and controls speech in healthy people. The investigators are doing this research because it will help identify the mechanisms that allow people to perceive their own speech errors and to learn new speech sounds, which may be applied to people who have communication disorders. 15 participants will be enrolled into this part of the study and can expect to be on study for 4 visits of 2-4 hours each.

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Key information

Conditions

Speech Behavior Communication Verbal Behavior

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

About this study

The overall study (Establishing the clinical utility of sensorimotor adaptation for speech rehabilitation) aims to understand how cognitive, perceptual, and motor processes are integrated in the control of speech movements. The investigators study how this complex skill is performed in healthy speakers to understand how this system functions, how this skill relates to the perception of speech, and what role different parts of the brain play in this process. Different studies look at how speech motor control is executed, maintained, and changed. Overall, the study will recruit 329 participants over the course of 5 years. Participants can expect to be on study for up to 3 weeks.

The entire study is composed of 8 experiments and 6 interventions. The present record represents the experiments involving transcranial magnetic stimulation (TMS), i.e. Experiment 7: Using TMS to alter somatosensory acuity.

This paradigm uses theta-burst transcranial magnetic stimulation (tbTMS) to modulate the excitability of sensory cortices to examine the effect on sensory acuity and sensorimotor adaptation. Participants will complete three total sessions targeting primary somatosensory cortex (S1): one using intermittent theta-burst stimulation (iTBS), one using continuous theta-burst stimulation (cTBS), and one with sham stimulation.

The effect of the stimulation on auditory acuity will be measured through a tactile discrimination task in which participants report the relative amplitude and/or timing of vibrating probes pressed lightly into the tongue using a custom device (a version of the Corticalmetrics Brain Gauge adapted to study the orofacial system).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(Control):

  • English-speaking adults
  • normal hearing and speech
  • no history of stroke or neurological conditions

Exclusion criteria

  • Native language other than English
  • Any neurological disorders other than the disorder of interest
  • Any history of hearing disorders
  • Uncorrected vision problems that prevent participants from seeing visually-presented stimuli
  • Significant cognitive impairments that prevent participants from carrying out the task or from giving informed consent
  • Vulnerable populations (minors and prisoners)
  • Additional exclusionary criteria for TMS:
  • Implanted paramagnetic materials (metal clips, plates, pacemakers, etc.)
  • Increased risk in the event of a seizure
  • Serious heart disease
  • Increased intracranial pressure
  • Pregnancy
  • History of seizures
  • Family history of epilepsy
  • Epileptogenic medications
  • Chronic or transient disruption of sleep (including jet lag)
  • History of fainting
  • Chronic or transient increase in stressful experiences
  • Use of illegal drugs

Treatment and study plan

TMS

Device

This paradigm uses theta-burst transcranial magnetic stimulation (tbTMS) to modulate the excitability of sensory cortices to examine the effect on sensory acuity and sensorimotor adaptation. Participants will complete three total sessions targeting primary somatosensory cortex (S1): one using intermittent theta-burst stimulation (iTBS), one using continuous theta-burst stimulation (cTBS), and one with sham stimulation.

Other names: transcranial magnetic stimulation (continuous and intermittent theta-burst stimulation), electromyography (EMG)

somatosensory acuity measurement

Behavioral

Somatosensory acuity will be measured through a tactile discrimination task using the corticalmetrics Brain Gauge. Participants lightly press their tongue onto two vibrating probes and report which one vibrated first or with greater amplitude.

Primary outcomes

  1. Somatosensory Acuity: Spatial Amplitude Discrimination Threshold (SDT)

    Time frame: up to 1 hour

    The investigators will measure thresholds in spatial amplitude discrimination (SDT). These thresholds represent the smallest difference that participants can detect in the amplitude of vibration on the tongue. Vibratory stimulation is delivered by the corticalmetrics Brain Gauge device, which has two probes, one on the left and one on the right side of the tongue. Participants will complete three total sessions targeting primary somatosensory cortex (S1): one using intermittent theta-burst stimulation (iTBS), one using continuous theta-burst stimulation (cTBS), and one with sham stimulation.

    Tactile acuity measured in this way is used as a proxy for full somatosensation, given the difficulty in measuring proprioception in the oral system. Tactile acuity has been suggested to be important for speech production, as tactile contact is maintained parasagittally during vowel production and tactile deprivation leads to imprecise speech movements.

  2. Somatosensory Acuity: Temporal Discrimination Threshold (TDT)

    Time frame: up to 1 hour

    The investigators will measure thresholds in temporal discrimination (SDT). These thresholds represent the smallest difference that participants can detect in the timing of vibrations on the tongue. Vibratory stimulation is delivered by the corticalmetrics Brain Gauge device, which has two probes, one on the left and one on the right side of the tongue. Participants will complete three total sessions targeting primary somatosensory cortex (S1): one using intermittent theta-burst stimulation (iTBS), one using continuous theta-burst stimulation (cTBS), and one with sham stimulation.

    Tactile acuity measured in this way is used as a proxy for full somatosensation, given the difficulty in measuring proprioception in the oral system. Tactile acuity has been suggested to be important for speech production, as tactile contact is maintained parasagittally during vowel production and tactile deprivation leads to imprecise speech movements.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

Behavioral and Neural Measures of Speech Motor Control

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 10, 2023
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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