Trial Outcomes & Findings for Modulation of Sensory Acuity With Transcranial Magnetic Stimulation (TMS) (NCT NCT05723575)

Last Updated: 2024-12-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

up to 1 hour

Results posted on

2024-12-17

Participant Flow

15 people provided data for this study from November 2022 to May 2023

Participant milestones

Participant milestones
Measure	Healthy Adult Speakers healthy adult participants across the lifespan in three groups:18-35, 36-55, and 56+ 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. 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.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Modulation of Sensory Acuity With Transcranial Magnetic Stimulation (TMS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Adult Speakers n=15 Participants healthy adult participants across the lifespan in three groups:18-35, 36-55, and 56+ 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. 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.
Age, Continuous	25 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 1 hour

Outcome measures

Outcome measures
Measure	Healthy Adult Speakers n=15 Participants healthy adult participants across the lifespan in three groups:18-35, 36-55, and 56+ 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. 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.
Somatosensory Acuity: Spatial Amplitude Discrimination Threshold (SDT) SDT (cTBS)	20.08 change in threshold (µm) Standard Error 7.37
Somatosensory Acuity: Spatial Amplitude Discrimination Threshold (SDT) SDT (iTBS)	-8.07 change in threshold (µm) Standard Error 3.74
Somatosensory Acuity: Spatial Amplitude Discrimination Threshold (SDT) SDT (sham)	5.39 change in threshold (µm) Standard Error 5.59
Somatosensory Acuity: Spatial Amplitude Discrimination Threshold (SDT) SDT (control)	-2.81 change in threshold (µm) Standard Error 5.24

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Healthy Adult Speakers n=15 Participants healthy adult participants across the lifespan in three groups:18-35, 36-55, and 56+ 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. 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.
Somatosensory Acuity: Temporal Discrimination Threshold (TDT) TDT (cTBS)	0.41 change in threshold (ms) Standard Error 6.44
Somatosensory Acuity: Temporal Discrimination Threshold (TDT) TDT (iTBS)	5.80 change in threshold (ms) Standard Error 3.59
Somatosensory Acuity: Temporal Discrimination Threshold (TDT) TDT (sham)	4.54 change in threshold (ms) Standard Error 6.60
Somatosensory Acuity: Temporal Discrimination Threshold (TDT) TDT (control)	-2.97 change in threshold (ms) Standard Error 6.25

Adverse Events

Healthy Adult Speakers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Carrie Niziolek, PhD

University of Wisconsin - Madison

Phone: (608) 262-7583

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place