Beta Events and Sensory Perception

NCT04062318 | Completed Results FDA Device

• 2 other identifiers: 1902002327P20GM103645
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Low-frequency brain rhythms in the alpha (8-14Hz) and beta (15-29Hz) bands are strong predictors of perception and functional performance in a range of tasks, and are disrupted in several disease states. The purpose of this study is to investigate a direct causal relationship between low-frequency brain rhythms and sensory perception, and to optimize commonly used TMS paradigms to impact sensory processing and perception in a similar manner as endogenous rhythms. To do so, this study combines human magnetic resonance imaging (MRI), electroencephalography (EEG), non-invasive brain stimulation (transcranial magnetic stimulation; TMS), and biophysically principled computational neural modeling.

Conditions

Beta Rhythm; Tactile Perception

Keywords

somatosensory; tactile; perception; electroencephalography; transcranial magnetic stimulation; beta rhythm

Outcome Measures

Primary Outcomes (1)

• Threshold-Level Tactile Detection Hit Rate

  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.

  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.

Secondary Outcomes (1)

• EEG Tactile Evoked Response Potential (ERP)

  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.

Study Arms (2)

Active SI-Hand TMS vs. Active Control TMS

EXPERIMENTAL

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.

Device: Online Active SI-Hand TMS; Device: Online Active Control TMS

Active SI-Hand TMS vs. Sham SI-Hand TMS

EXPERIMENTAL

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)

Device: Online Active SI-Hand TMS; Device: Online Sham SI-Hand TMS

Interventions

Online Active SI-Hand TMS DEVICE

Single pulses of TMS will be delivered using an active coil. One pulse will be delivered per trial (at least 5 seconds apart) "online" (during the tactile detection task), at 80% active motor threshold. TMS will target the hand area of primary somatosensory cortex (SI-Hand).

Active SI-Hand TMS vs. Active Control TMS; Active SI-Hand TMS vs. Sham SI-Hand TMS

Online Sham SI-Hand TMS DEVICE

Single pulses of TMS will be delivered using a sham coil. One pulse will be delivered per trial (at least 5 seconds apart) "online" (during the tactile detection task), at 80% active motor threshold. TMS will target the hand area of primary somatosensory cortex (SI-Hand). This control condition is intended to mimic the peripheral (e.g. cranial/facial muscle and/or nerve activation, auditory evoked response), but not biological effects of TMS specifically related to somatosensory perception.

Active SI-Hand TMS vs. Sham SI-Hand TMS

Online Active Control TMS DEVICE

Single pulses of TMS will be delivered using an active coil. One pulse will be delivered per trial (at least 5 seconds apart) "online" (during the tactile detection task), at 80% active motor threshold. TMS will target a control brain region, in a more superior and lateral location within SI. This control condition is intended to mimic the peripheral (e.g. cranial/facial muscle and/or nerve activation, auditory evoked response), but not biological effects of TMS specifically related to somatosensory perception.

Active SI-Hand TMS vs. Active Control TMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide informed consent/assent
• Age: 18-65 years
• English fluency: participants must be able to understand screening questionnaires and task instructions spoken/written in English.
• Right handed: to reduce heterogeneity related to hand dominance, since our task involves touch perception on the hand, and examination of neural correlates in lateralized brain regions.

You may not qualify if:

• History of fainting spells of unknown or undetermined etiology that might constitute seizures
• History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy
• Any progressive (e.g., neurodegenerative) neurological disorder
• Chronic medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
• Metal implants (excluding dental fillings)
• Pacemaker
• Implanted medication pump or cochlear implant
• Vagal nerve stimulator
• Deep brain stimulator
• TENS unit (unless removed completely for the study)
• Ventriculo-peritoneal shunt
• Signs of increased intracranial pressure
• Intracranial lesion
• History of head injury resulting in prolonged loss of consciousness
• Pregnancy

Sponsors & Collaborators

• Brown University: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Brown University, Carney Institute for Brain Science Human Testing Space (HuTS)

Providence, Rhode Island, 02906, United States

Location

Related Publications (5)

• Jones SR, Kerr CE, Wan Q, Pritchett DL, Hamalainen M, Moore CI. Cued spatial attention drives functionally relevant modulation of the mu rhythm in primary somatosensory cortex. J Neurosci. 2010 Oct 13;30(41):13760-5. doi: 10.1523/JNEUROSCI.2969-10.2010.

  PMID: 20943916 BACKGROUND

• Sherman MA, Lee S, Law R, Haegens S, Thorn CA, Hamalainen MS, Moore CI, Jones SR. Neural mechanisms of transient neocortical beta rhythms: Converging evidence from humans, computational modeling, monkeys, and mice. Proc Natl Acad Sci U S A. 2016 Aug 16;113(33):E4885-94. doi: 10.1073/pnas.1604135113. Epub 2016 Jul 28.

  PMID: 27469163 BACKGROUND

• Shin H, Law R, Tsutsui S, Moore CI, Jones SR. The rate of transient beta frequency events predicts behavior across tasks and species. Elife. 2017 Nov 6;6:e29086. doi: 10.7554/eLife.29086.

  PMID: 29106374 BACKGROUND

• Jones SR, Pritchett DL, Stufflebeam SM, Hamalainen M, Moore CI. Neural correlates of tactile detection: a combined magnetoencephalography and biophysically based computational modeling study. J Neurosci. 2007 Oct 3;27(40):10751-64. doi: 10.1523/JNEUROSCI.0482-07.2007.

  PMID: 17913909 BACKGROUND

• Jones SR, Pritchett DL, Sikora MA, Stufflebeam SM, Hamalainen M, Moore CI. Quantitative analysis and biophysically realistic neural modeling of the MEG mu rhythm: rhythmogenesis and modulation of sensory-evoked responses. J Neurophysiol. 2009 Dec;102(6):3554-72. doi: 10.1152/jn.00535.2009. Epub 2009 Oct 7.

  PMID: 19812290 BACKGROUND

Limitations and Caveats

A study limitation is that the active control TMS site was close in proximity within primary somatosensory cortex to our target site, and likely highly functionally connected. This may be why we found similar behavioral effects of TMS on tactile detection hit rate for TMS delivered to the active target and control locations, and is why we followed up by adding on a sham control group.

Results Point of Contact

• Title: Danielle Sliva, Postdoctoral Research Associate
• Organization: Brown University

danielle_sliva@brown.edu

(203) 673-2194

Study Officials

• Stephanie R Jones, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be unaware of the TMS target, type of coil (active vs. sham) and order in which they receive TMS interventions.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will complete an initial MRI. MRIs are subsequently used for TMS neuronavigation (region of interest targeting). There is no intervention applied during the MRI session. In one of two subsequent concurrent TMS-EEG sessions, all participants will receive active TMS to the hand area of primary somatosensory cortex (SI; active SI-Hand TMS) while carrying out a tactile detection task. During the other TMS-EEG session, participants will either receive active TMS over a control brain region in a more medial and superior region of SI (active control TMS), or sham TMS over the hand area of SI (sham SI-Hand control TMS). The order of active SI TMS vs. control (active control or sham SI control) will be randomized across participants.

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: August 20, 2019
• Study Start: July 25, 2019
• Primary Completion: November 2, 2024
• Study Completion: November 2, 2024
• Last Updated: February 23, 2026
• Results First Posted: February 23, 2026

Record last verified: 2025-09

Locations

US (1)