Trial Outcomes & Findings for Beta Events and Sensory Perception (NCT NCT04062318)

Last Updated: 2026-02-23

Results Overview

Participants receive one or zero tactile stimuli per trial and report detection or non-detection using a button press. Tactile stimuli are delivered at participants' individual perceptual threshold level (perceived roughly half the time). On a given trial, TMS may also be delivered 100 msec before the tap ('TMS100'), 25 msec after the tap ('TMS25'), or not at all ('TMS Null'), each for an equal number of trials. The 'hit rate' is defined as the number of trials with correctly detected tactile stimuli divided by the total number of trials on which a tactile stimulus was presented.

Recruitment status

COMPLETED

Study phase

Target enrollment

39 participants

Primary outcome timeframe

Tactile detection was assessed between TMS and no TMS trials continuously during the TMS interventions - during the Active SI TMS session, and during either the Active Control TMS or Sham Control TMS session. The sessions were at least 1 week apart.

Results posted on

2026-02-23

Participant Flow

Healthy adult participants (ages 18-65 years) were recruited from the greater Providence, RI area. Inclusion criteria included the ability to provide informed consent, english fluency, and right-handedness. Exclusion criteria included any prior or existing condition(s) that could increase the risk of side effects or complications from TMS or MRI, neurological or medical conditions that could confound experimental results, and any pharmaceutical agents that could increase seizure risk from TMS.

39 participants met criteria for enrollment, were consented and completed an MRI. 26 were assigned to receive Active SI-Hand and Active Control TMS, 13 were assigned to receive Active SI-Hand and Sham SI-Hand TMS, in different sessions at least one week apart (repeated measures design). One participant was consented once, and received Active SI-Hand TMS and both control arms (Active Control \& Sham) - but is counted once in the 'Active SI-Hand/Control' group for baseline characteristics.

Participant milestones

Participant milestones
Measure	Active SI-Hand TMS vs. Active Control TMS Participants receive perceptual threshold-level tactile stimuli to the third digit of the right hand and report detection or non-detection. EEG is recorded and TMS is applied concurrently during the task. In one study session, active TMS is applied over the hand region of primary somatosensory cortex (SI-Hand). In another study session, active TMS is applied over a control brain region, in a more superior and lateral location within SI.	Active SI-Hand TMS vs. Sham SI-Hand TMS Participants receive perceptual threshold-level tactile stimuli to the third digit of the right hand and report detection or non-detection. EEG is recorded and TMS is applied concurrently during the task. In one study session, active TMS is applied over the hand region of primary somatosensory cortex (SI-Hand). In another study session, sham TMS is applied over the same target location (SI-Hand).
Overall Study STARTED	26	13
Overall Study COMPLETED	20	8
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Active SI-Hand TMS vs. Active Control TMS Participants receive perceptual threshold-level tactile stimuli to the third digit of the right hand and report detection or non-detection. EEG is recorded and TMS is applied concurrently during the task. In one study session, active TMS is applied over the hand region of primary somatosensory cortex (SI-Hand). In another study session, active TMS is applied over a control brain region, in a more superior and lateral location within SI.	Active SI-Hand TMS vs. Sham SI-Hand TMS Participants receive perceptual threshold-level tactile stimuli to the third digit of the right hand and report detection or non-detection. EEG is recorded and TMS is applied concurrently during the task. In one study session, active TMS is applied over the hand region of primary somatosensory cortex (SI-Hand). In another study session, sham TMS is applied over the same target location (SI-Hand).
Overall Study New exclusionary medication or medical condition	1	1
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	4	2
Overall Study Lab equipment broke during session	0	2

Baseline Characteristics

The population numbers represent enrolled participants who completed the behavioral testing procedure for two full sessions, Active SI-Hand TMS and one of the two control sessions. The other participants either dropped out before doing any TMS session, or after the first TMS session.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active SI-Hand TMS vs. Active Control TMS n=26 Participants Participants receive perceptual threshold-level tactile stimuli to the third digit of the right hand and report detection or non-detection. EEG is recorded and TMS is applied concurrently during the task. In one study session, active TMS is applied over the hand region of primary somatosensory cortex (SI-Hand). In another study session, active TMS is applied over a control brain region, in a more superior and lateral location within SI.	Active SI-Hand TMS vs. Sham SI-Hand TMS n=13 Participants Participants receive perceptual threshold-level tactile stimuli to the third digit of the right hand and report detection or non-detection. EEG is recorded and TMS is applied concurrently during the task. In one study session, active TMS is applied over the hand region of primary somatosensory cortex (SI-Hand). In another study session, sham TMS is applied over the same target location (SI-Hand).	Total n=39 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=26 Participants	0 Participants n=13 Participants	3 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=26 Participants	13 Participants n=13 Participants	36 Participants n=39 Participants
Age, Categorical >=65 years	0 Participants n=26 Participants	0 Participants n=13 Participants	0 Participants n=39 Participants
Sex: Female, Male Female	13 Participants n=26 Participants	4 Participants n=13 Participants	17 Participants n=39 Participants
Sex: Female, Male Male	13 Participants n=26 Participants	9 Participants n=13 Participants	22 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=26 Participants	0 Participants n=13 Participants	0 Participants n=39 Participants
Race (NIH/OMB) Asian	6 Participants n=26 Participants	4 Participants n=13 Participants	10 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=26 Participants	0 Participants n=13 Participants	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	1 Participants n=26 Participants	1 Participants n=13 Participants	2 Participants n=39 Participants
Race (NIH/OMB) White	10 Participants n=26 Participants	8 Participants n=13 Participants	18 Participants n=39 Participants
Race (NIH/OMB) More than one race	4 Participants n=26 Participants	0 Participants n=13 Participants	4 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=26 Participants	0 Participants n=13 Participants	5 Participants n=39 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=26 Participants	3 Participants n=13 Participants	9 Participants n=39 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=26 Participants	10 Participants n=13 Participants	24 Participants n=39 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=26 Participants	0 Participants n=13 Participants	6 Participants n=39 Participants
Active SI-Hand Tactile Detection Threshold.	0.33 Volts (V) STANDARD_DEVIATION 0.19 • n=20 Participants • The population numbers represent enrolled participants who completed the behavioral testing procedure for two full sessions, Active SI-Hand TMS and one of the two control sessions. The other participants either dropped out before doing any TMS session, or after the first TMS session.	0.19 Volts (V) STANDARD_DEVIATION 0.12 • n=8 Participants • The population numbers represent enrolled participants who completed the behavioral testing procedure for two full sessions, Active SI-Hand TMS and one of the two control sessions. The other participants either dropped out before doing any TMS session, or after the first TMS session.	0.28 Volts (V) STANDARD_DEVIATION 0.17 • n=28 Participants • The population numbers represent enrolled participants who completed the behavioral testing procedure for two full sessions, Active SI-Hand TMS and one of the two control sessions. The other participants either dropped out before doing any TMS session, or after the first TMS session.

PRIMARY outcome

Timeframe: Tactile detection was assessed between TMS and no TMS trials continuously during the TMS interventions - during the Active SI TMS session, and during either the Active Control TMS or Sham Control TMS session. The sessions were at least 1 week apart.

Population: The numbers of participants analyzed in this section are lower than the number in the 'baseline characteristics' section because only participants who completed two sessions (Active SI-Hand TMS and a control session) were included in the within-subjects analysis. One subject completed both control conditions, and it counted in both the 'Active Control Group' and the 'Sham Control Group'.

Outcome measures

Outcome measures
Measure	Active Control TMS100 n=20 Participants These participants received TMS using an active coil to a control region within outside of the study main region of interest. TMS was delivered 100 msec before the threshold-level finger tap.	Sham Control TMS Null n=9 Participants These participants received TMS using a sham coil to the study main region of interest, hand representation of primary somatosensory cortex (SI). TMS not delivered on these trials.	Sham Control TMS25 n=9 Participants These participants received TMS using a sham coil to the study main region of interest, hand representation of primary somatosensory cortex (SI). TMS was delivered 25 msec after the threshold-level finger tap.	Sham Control TMS100 n=9 Participants These participants received TMS using a sham coil to the study main region of interest, hand representation of primary somatosensory cortex (SI). TMS was delivered 100 msec before the threshold-level finger tap.	Active SI TMS Null (Active Control Group) n=20 Participants These participants received TMS using an active coil to the study main region of interest, hand representation of primary somatosensory cortex (SI). TMS not delivered on these trials.	Active SI TMS25 (Active Control Group) n=20 Participants These participants received TMS using an active coil to the study main region of interest, hand representation of primary somatosensory cortex (SI). TMS was delivered 25 msec after the threshold-level finger tap.	Active SI TMS100 (Active Control Group) n=20 Participants These participants received TMS using an active coil to the study main region of interest, hand representation of primary somatosensory cortex (SI). TMS was delivered 100 msec before the threshold-level finger tap.	Active Control TMS Null n=20 Participants These participants received TMS using an active coil to a control region within outside of the study main region of interest. TMS not delivered on these trials.	Active Control TMS25 n=20 Participants These participants received TMS using an active coil to a control region within outside of the study main region of interest. TMS was delivered 25 msec after the threshold-level finger tap.	Active SI TMS Null (Sham Control Group) n=9 Participants These participants received TMS using an active coil to the study main region of interest, hand representation of primary somatosensory cortex (SI). TMS was delivered 25 msec after the threshold-level finger tap.	Active SI TMS25 (Sham Control Group) n=9 Participants These participants received TMS using an active coil to the study main region of interest, hand representation of primary somatosensory cortex (SI). TMS was delivered 25 msec after the threshold-level finger tap.	Active SI TMS100 (Sham Control Group) n=9 Participants These participants received TMS using an active coil to the study main region of interest, hand representation of primary somatosensory cortex (SI). TMS was delivered 100 msec before the threshold-level finger tap.
Threshold-Level Tactile Detection Hit Rate	0.42 # hit trials/(total # hit + miss trials) Standard Deviation 0.12	0.31 # hit trials/(total # hit + miss trials) Standard Deviation 0.12	0.38 # hit trials/(total # hit + miss trials) Standard Deviation 0.12	0.40 # hit trials/(total # hit + miss trials) Standard Deviation 0.11	0.37 # hit trials/(total # hit + miss trials) Standard Deviation 0.11	0.46 # hit trials/(total # hit + miss trials) Standard Deviation 0.12	0.47 # hit trials/(total # hit + miss trials) Standard Deviation 0.11	0.32 # hit trials/(total # hit + miss trials) Standard Deviation 0.10	0.41 # hit trials/(total # hit + miss trials) Standard Deviation 0.12	0.39 # hit trials/(total # hit + miss trials) Standard Deviation 0.10	0.42 # hit trials/(total # hit + miss trials) Standard Deviation 0.11	0.40 # hit trials/(total # hit + miss trials) Standard Deviation 0.10

SECONDARY outcome

Timeframe: EEG measures were assessed between TMS and no TMS trials continuously during the TMS interventions - during the Active SI TMS session, and during either the Active Control TMS or Sham Control TMS session. The sessions were at least 1 week apart.

Population: The numbers and arms of participants analyzed in this section are different than that of the 'primary outcome' section because we only included participants with high-quality EEG data, and only assessed the Active SI-Hand TMS Group, as we were interested in following up on the behavioral effect of TMS timing on hit rate (primary outcome measure) in our target location.

Participants receive one tactile stimulus per trial concurrent with EEG recording. The EEG-measured ERP immediately following each tactile stimulus is assessed and compared across conditions, with and without TMS at different latencies. 'TMS null' refers to trials in which no TMS was delivered, 'TMS100' refers to trials in which TMS was delivered 100 msec before the tactile stimulus, and 'TMS25' refers to trials in which TMS was delivered 25 msec after the tactile stimulus. 'Hit trials' are trials in which the tactile stimulus was delivered and corrected detected, and 'miss trials' are trials in which the tactile stimulus was delivered but incorrectly not detected. The outcome measure calculated here represents a time window between 78-161 msec after the tactile stimulus, where we expected to see a significant difference in signal amplitude between hit and miss trials based on prior publications.

Outcome measures

Outcome measures
Measure	Active Control TMS100 n=18 Participants These participants received TMS using an active coil to a control region within outside of the study main region of interest. TMS was delivered 100 msec before the threshold-level finger tap.	Sham Control TMS Null These participants received TMS using a sham coil to the study main region of interest, hand representation of primary somatosensory cortex (SI). TMS not delivered on these trials.	Sham Control TMS25 These participants received TMS using a sham coil to the study main region of interest, hand representation of primary somatosensory cortex (SI). TMS was delivered 25 msec after the threshold-level finger tap.	Sham Control TMS100 These participants received TMS using a sham coil to the study main region of interest, hand representation of primary somatosensory cortex (SI). TMS was delivered 100 msec before the threshold-level finger tap.	Active SI TMS Null (Active Control Group) n=18 Participants These participants received TMS using an active coil to the study main region of interest, hand representation of primary somatosensory cortex (SI). TMS not delivered on these trials.	Active SI TMS25 (Active Control Group) n=18 Participants These participants received TMS using an active coil to the study main region of interest, hand representation of primary somatosensory cortex (SI). TMS was delivered 25 msec after the threshold-level finger tap.	Active SI TMS100 (Active Control Group) n=18 Participants These participants received TMS using an active coil to the study main region of interest, hand representation of primary somatosensory cortex (SI). TMS was delivered 100 msec before the threshold-level finger tap.	Active Control TMS Null n=18 Participants These participants received TMS using an active coil to a control region within outside of the study main region of interest. TMS not delivered on these trials.	Active Control TMS25 n=18 Participants These participants received TMS using an active coil to a control region within outside of the study main region of interest. TMS was delivered 25 msec after the threshold-level finger tap.	Active SI TMS Null (Sham Control Group) These participants received TMS using an active coil to the study main region of interest, hand representation of primary somatosensory cortex (SI). TMS was delivered 25 msec after the threshold-level finger tap.	Active SI TMS25 (Sham Control Group) These participants received TMS using an active coil to the study main region of interest, hand representation of primary somatosensory cortex (SI). TMS was delivered 25 msec after the threshold-level finger tap.	Active SI TMS100 (Sham Control Group) These participants received TMS using an active coil to the study main region of interest, hand representation of primary somatosensory cortex (SI). TMS was delivered 100 msec before the threshold-level finger tap.
EEG Tactile Evoked Response Potential (ERP)	0.0727 EEG signal amplitude (microvolts) Standard Deviation 0.9644	—	—	—	-0.7937 EEG signal amplitude (microvolts) Standard Deviation 0.8361	-0.2330 EEG signal amplitude (microvolts) Standard Deviation 0.4005	-1.3684 EEG signal amplitude (microvolts) Standard Deviation 1.1736	-0.8988 EEG signal amplitude (microvolts) Standard Deviation 1.5002	0.0562 EEG signal amplitude (microvolts) Standard Deviation 0.8992	—	—	—

Adverse Events

MRI Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Active SI-Hand TMS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Active Control TMS

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Sham SI-Hand TMS

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MRI Only n=39 participants at risk Participants receive an MRI to inform TMS targeting and analysis.	Active SI-Hand TMS n=39 participants at risk Participants receive perceptual threshold-level tactile stimuli to the third digit of the right hand and report detection or non-detection. EEG is recorded and active TMS is applied concurrently over the hand region of primary somatosensory cortex (SI-Hand) during the task.	Active Control TMS n=26 participants at risk Participants receive perceptual threshold-level tactile stimuli to the third digit of the right hand and report detection or non-detection. EEG is recorded and active TMS is applied concurrently over a control brain region, in a more superior and lateral location within SI, during the task.	Sham SI-Hand TMS n=13 participants at risk Participants receive perceptual threshold-level tactile stimuli to the third digit of the right hand and report detection or non-detection. EEG is recorded and sham TMS is applied concurrently over the hand region of primary somatosensory cortex (SI-Hand) during the task.
Skin and subcutaneous tissue disorders New antibiotic medication	0.00% 0/39 • Adverse events were assessed at each study visit (MRI, first TMS-EEG, second TMS-EEG, third TMS-EEG if applicable), and covered the periods during and between visits, up to a total of 2 years (between the MRI to final TMS-EEG visits). All adverse events were unrelated to the study, but occurred after the first TMS-EEG session and resulted in the participant dropping out of the study and not completing the second TMS-EEG session.	0.00% 0/39 • Adverse events were assessed at each study visit (MRI, first TMS-EEG, second TMS-EEG, third TMS-EEG if applicable), and covered the periods during and between visits, up to a total of 2 years (between the MRI to final TMS-EEG visits). All adverse events were unrelated to the study, but occurred after the first TMS-EEG session and resulted in the participant dropping out of the study and not completing the second TMS-EEG session.	0.00% 0/26 • Adverse events were assessed at each study visit (MRI, first TMS-EEG, second TMS-EEG, third TMS-EEG if applicable), and covered the periods during and between visits, up to a total of 2 years (between the MRI to final TMS-EEG visits). All adverse events were unrelated to the study, but occurred after the first TMS-EEG session and resulted in the participant dropping out of the study and not completing the second TMS-EEG session.	7.7% 1/13 • Adverse events were assessed at each study visit (MRI, first TMS-EEG, second TMS-EEG, third TMS-EEG if applicable), and covered the periods during and between visits, up to a total of 2 years (between the MRI to final TMS-EEG visits). All adverse events were unrelated to the study, but occurred after the first TMS-EEG session and resulted in the participant dropping out of the study and not completing the second TMS-EEG session.
Nervous system disorders Migraine	0.00% 0/39 • Adverse events were assessed at each study visit (MRI, first TMS-EEG, second TMS-EEG, third TMS-EEG if applicable), and covered the periods during and between visits, up to a total of 2 years (between the MRI to final TMS-EEG visits). All adverse events were unrelated to the study, but occurred after the first TMS-EEG session and resulted in the participant dropping out of the study and not completing the second TMS-EEG session.	0.00% 0/39 • Adverse events were assessed at each study visit (MRI, first TMS-EEG, second TMS-EEG, third TMS-EEG if applicable), and covered the periods during and between visits, up to a total of 2 years (between the MRI to final TMS-EEG visits). All adverse events were unrelated to the study, but occurred after the first TMS-EEG session and resulted in the participant dropping out of the study and not completing the second TMS-EEG session.	3.8% 1/26 • Adverse events were assessed at each study visit (MRI, first TMS-EEG, second TMS-EEG, third TMS-EEG if applicable), and covered the periods during and between visits, up to a total of 2 years (between the MRI to final TMS-EEG visits). All adverse events were unrelated to the study, but occurred after the first TMS-EEG session and resulted in the participant dropping out of the study and not completing the second TMS-EEG session.	0.00% 0/13 • Adverse events were assessed at each study visit (MRI, first TMS-EEG, second TMS-EEG, third TMS-EEG if applicable), and covered the periods during and between visits, up to a total of 2 years (between the MRI to final TMS-EEG visits). All adverse events were unrelated to the study, but occurred after the first TMS-EEG session and resulted in the participant dropping out of the study and not completing the second TMS-EEG session.
Psychiatric disorders New psychiatric medication	0.00% 0/39 • Adverse events were assessed at each study visit (MRI, first TMS-EEG, second TMS-EEG, third TMS-EEG if applicable), and covered the periods during and between visits, up to a total of 2 years (between the MRI to final TMS-EEG visits). All adverse events were unrelated to the study, but occurred after the first TMS-EEG session and resulted in the participant dropping out of the study and not completing the second TMS-EEG session.	0.00% 0/39 • Adverse events were assessed at each study visit (MRI, first TMS-EEG, second TMS-EEG, third TMS-EEG if applicable), and covered the periods during and between visits, up to a total of 2 years (between the MRI to final TMS-EEG visits). All adverse events were unrelated to the study, but occurred after the first TMS-EEG session and resulted in the participant dropping out of the study and not completing the second TMS-EEG session.	0.00% 0/26 • Adverse events were assessed at each study visit (MRI, first TMS-EEG, second TMS-EEG, third TMS-EEG if applicable), and covered the periods during and between visits, up to a total of 2 years (between the MRI to final TMS-EEG visits). All adverse events were unrelated to the study, but occurred after the first TMS-EEG session and resulted in the participant dropping out of the study and not completing the second TMS-EEG session.	7.7% 1/13 • Adverse events were assessed at each study visit (MRI, first TMS-EEG, second TMS-EEG, third TMS-EEG if applicable), and covered the periods during and between visits, up to a total of 2 years (between the MRI to final TMS-EEG visits). All adverse events were unrelated to the study, but occurred after the first TMS-EEG session and resulted in the participant dropping out of the study and not completing the second TMS-EEG session.

Additional Information

Danielle Sliva, Postdoctoral Research Associate

Brown University

Phone: (203) 673-2194

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place