Modulation of Sensory Acuity With Transcranial Magnetic Stimulation (TMS)

Speech Clinical Trial

Official title:

Behavioral and Neural Measures of Speech Motor Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05723575
• Other study ID #: 2017-1128 TMS (Exp 7)
• Secondary ID: Protocol Version
• Status: Completed
• Phase: N/A
• Start date: November 18, 2022
• Est. completion date: May 26, 2023

Study information

• Verified date: January 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 26, 2023
• Est. primary completion date: May 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Speech

Intervention

Device:
• TMS
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.

Behavioral:
• somatosensory acuity measurement
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.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Somatosensory acuity	The investigators will measure thresholds in amplitude discrimination and temporal order judgment using the corticalmetrics Brain Gauge, using tactile acuity 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.	up to 1 hour

External Links

•   Link to study record for experiment 5 [NCT05286658]