- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04062318
Beta Events and Sensory Perception
The Causal Role of Neocortical Beta Events in Human Sensory Perception
Study Overview
Status
Conditions
Intervention / Treatment
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 and how the rate and timing of ongoing rhythmic events in the alpha/beta bands prior to a tactile stimulus causally impact touch perception, and how this relates to attention. A custom TMS protocol that is hypothesized to mimic endogenous beta-frequency event patterns is used to test whether TMS can impact perception in a similar manner. Finally, computational neural modeling designed to simulate macro-scale EEG signals is used to aid in the interpretation of potential neural circuit mechanisms underlying features of acquired EEG data.
The TMS-EEG components of this study will use a within-subjects crossover design. In initial study sessions, 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 or sham TMS. Analyses will focus on comparing detection probabilities of tactile stimuli presented at perceptual threshold and tactile evoked response potential waveforms between trials in which TMS pulses or endogenous beta events occur with similar timing and intensity.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Danielle D Sliva, MA
- Phone Number: 401-863-5351
- Email: danielle_sliva@brown.edu
Study Contact Backup
- Name: Simona Temereanca Ibanescu, PhD
- Email: simona_temereanca_ibanescu@brown.edu
Study Locations
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Rhode Island
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Providence, Rhode Island, United States, 02906
- Recruiting
- Brown University, Carney Institute for Brain Science Human Testing Space (HuTS)
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Contact:
- Danielle D Sliva, MA
- Phone Number: 401-863-5351
- Email: danielle_sliva@brown.edu
-
Contact:
- Simona Temereanca Ibanescu, PhD
- Email: simona_temereanca_ibanescu@brown.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tactile detection task with online TMS-EEG
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 over somatosensory cortex during the tactile detection task.
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One single pulse or triple pulse train (3 pulses, 20ms inter-pulse interval) of TMS will be delivered per trial (at least 5 seconds apart) "online", or during the tactile detection task, at less than or equal to 80% active motor threshold.
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Active Comparator: Tactile detection task with online control TMS-EEG
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 over a control brain region during the tactile detection task.
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.
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One single pulse or triple pulse train (3 pulses, 20ms inter-pulse interval) of TMS will be delivered per trial (at least 5 seconds apart) "online", or during the tactile detection task, at less than or equal to 80% active motor threshold.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Threshold-level tactile detection
Time Frame: Measures of tactile detection are collected during the tactile detection task, which is assessed on each study visit (with the exception of an MRI-only visit) throughout the course of study completion, an average of 6-12 months.
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Participants receive one tactile stimulus per trial and report detection or non-detection using a button press.
Stimuli are delivered at one of three intensities: perceptual threshold-level (70% of trials), suprathreshold-level (always perceived, 10% of trials) or null stimuli (no stimulus, 20% of trials).
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Measures of tactile detection are collected during the tactile detection task, which is assessed on each study visit (with the exception of an MRI-only visit) throughout the course of study completion, an average of 6-12 months.
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EEG tactile evoked response potential (ERP)
Time Frame: EEG measures are collected during the tactile detection task, which is assessed on each study visit (with the exception of an MRI-only visit) throughout the course of study completion, an average of 6-12 months.
|
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.
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EEG measures are collected during the tactile detection task, which is assessed on each study visit (with the exception of an MRI-only visit) throughout the course of study completion, an average of 6-12 months.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephanie R Jones, PhD, Brown University
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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. Erratum In: J Neurophysiol. 2014 Dec 15;112(12):3251.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1902002327
- P20GM103645 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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