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Beta RhythmNCT04062318

Beta Events and Sensory Perception

A study testing Online Active SI-Hand TMS in people with Beta Rhythm and Tactile Perception, run by Brown University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Beta Rhythm, Tactile Perception
What is being tested?
Online Active SI-Hand TMS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
39 participants
Where
1 siteUnited States
Study dates
25 Jul 2019to 2 Nov 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 22Show fewer
  • 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
  • Participants who have received prior TMS for medical treatment purposes.
  • Intellectual Disability or autism spectrum disorder (ASD)
  • Active psychosis, diagnosis of unipolar depression or bipolar disorder, active severe substance use disorders (within the last month), or active suicidal intent or ideations.
  • Conditions that may result in the inability to effectively carry out the tactile detection task, including loss of feeling, neuropathy or nerve damage in the hands or feet, chronic pain or fibromyalgia, and pain due to cancer, infection or arthritis.
  • If the participant is actively taking any of the medications that increase risk from TMS as indicated below, of if they have ingested any alcohol or any other drugs of abuse (see https://www.drugabuse.gov/drugs-abuse) on the day of the study session (prior to the session).
  • Contraindicated medications:
  • alcohol Amitriptyline Amphetamines ampicillin Anticholinergics Antihistamines aripiprazole BCNU bupropion cephalosporins chlorambucil chloroquine Chlorpromazine citalopram Clozapine Cocaine cyclosporine cytosine arabinoside Doxepine duloxetine fluoxetine fluphenazine fluvoxamine Foscarnet gamma-hydroxybutyrate (GHB) Ganciclovir haloperidol imipenem Imipramine isoniazid ketamine levofloxacin Lithium Maprotiline MDMA (ecstasy) mefloquine methotrexate metronidazole mianserin mirtazapine Nortriptyline olanzapine paroxetine penicillin phencyclidine (PCP, angel's dust) pimozide quetiapine reboxetine risperidone Ritonavir Sertraline Sympathomimetic theophylline venlafaxine vincristine ziprasidone

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Brown University, Carney Institute for Brain Science Human Testing Space (HuTS)

    Providence, Rhode Island, 02906

Other trials in United States

About this study

Official title: The Causal Role of Neocortical Beta Events in Human Sensory Perception

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.

Read the detailed description

Prior studies have shown that high power low-frequency brain rhythms in the alpha (8-14) and beta (15-29 Hz) bands in primary somatosensory cortex (SI) are associated with a decreased probability of perceiving tactile stimuli at perceptual threshold, and can be modulated with attention. Furthermore, high power beta activity in SI emerges as brief "events" (<150ms) in un-averaged data, the rate and timing of which underlie the attentional and perceptual effects associated with high beta power.

In this study, human electroencephalography (EEG) and a non-painful tactile detection task are used to assess if TMS that is hypothesized to mimic endogenous beta-frequency events impact touch perception in a similar manner.

The TMS-EEG components of this study will use a within-subjects crossover design. In initial study sessions, all participants will have an MRI. In subsequent study sessions, participants will complete a tactile detection task while EEG data is recorded concurrent with online active, active control or sham control TMS. Analyses will focus on comparing detection probabilities of tactile stimuli presented at perceptual threshold and tactile evoked response potential waveforms between trials with and without concurrent TMS.

Being tested
Online Active SI-Hand TMS, Online Sham SI-Hand TMS, Online Active Control TMS
Keywords
somatosensory, tactile, perception, electroencephalography, transcranial magnetic stimulation, beta rhythm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online Active SI-Hand TMSDevice

    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).

  • Online Sham SI-Hand TMSDevice

    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.

  • Online Active Control TMSDevice

    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.

Study groups in NCT04062318
Study groupRoleWhat they receive
Active SI-Hand TMS vs. Active Control TMSExperimentalParticipants 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.
Receives: Device: Online Active SI-Hand TMS; Device: Online Active Control TMS
Active SI-Hand TMS vs. Sham SI-Hand TMSExperimentalParticipants 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)
Receives: Device: Online Active SI-Hand TMS; Device: Online Sham SI-Hand TMS

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  1. EEG Tactile Evoked Response Potential (ERP)

    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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2019
  2. Study start25 Jul 2019
  3. Primary completion2 Nov 2024
  4. Study completion2 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04062318
Sponsor's protocol ID
1902002327
Other IDs
P20GM103645
Status last verified
Sep 2025
First submitted
16 Aug 2019
Last updated
23 Feb 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 20943916
  • 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.

    PubMed 27469163
  • 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.

    PubMed 29106374
  • 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.

    PubMed 17913909
  • 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.

    PubMed 19812290

Questions about this trial

What is this clinical trial studying?

A study testing Online Active SI-Hand TMS in people with Beta Rhythm and Tactile Perception, run by Brown University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Threshold-Level Tactile Detection Hit Rate (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04062318, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.

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