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Beta Events and Sensory Perception

The Causal Role of Neocortical Beta Events in Human Sensory Perception

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04062318
Enrollment
39
Registered
2019-08-20
Start date
2019-07-25
Completion date
2024-11-02
Last updated
2026-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Beta Rhythm, Tactile Perception

Keywords

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

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.

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.

Interventions

DEVICEOnline Active SI-Hand TMS

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).

DEVICEOnline Sham SI-Hand TMS

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.

DEVICEOnline Active Control TMS

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.

Sponsors

Brown University
Lead SponsorOTHER
National Institute of General Medical Sciences (NIGMS)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Masking description

Participants will be unaware of the TMS target, type of coil (active vs. sham) and order in which they receive TMS interventions.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Threshold-Level Tactile Detection Hit RateTactile 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.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.

Secondary

MeasureTime frameDescription
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.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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORStephanie R Jones, PhD

Brown University

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Baseline characteristics

Characteristic
Active SI-Hand Tactile Detection Threshold.0.28 Volts (V)
STANDARD_DEVIATION 0.17
Age, Categorical
<=18 years
3 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
23 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
10 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
6 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
10 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants
Race (NIH/OMB)
White
18 Participants
Sex: Female, Male
Female
17 Participants
Sex: Female, Male
Male
22 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 390 / 390 / 260 / 13
other
Total, other adverse events
0 / 390 / 391 / 262 / 13
serious
Total, serious adverse events
0 / 390 / 390 / 260 / 13

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026