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NCT04062318

Beta Events and Sensory Perception

Completed NA Results posted Last updated 23 February 2026
What this trial tests

NA trial testing Online Active SI-Hand TMS in Beta Rhythm in 39 participants. Completed in 2 November 2024.

Timeline
25 July 2019
Primary endpoint
2 November 2024
2 November 2024

Quick facts

Lead sponsorBrown University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposebasic science
Enrollment39
Start date25 July 2019
Primary completion2 November 2024
Estimated completion2 November 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Brown University

Who can join

Adults 18 to 65, any sex, with Beta Rhythm or Tactile Perception. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Threshold-Level Tactile Detection Hit Rate Primary · 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.

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.

GroupValue95% CI
Active SI TMS Null (Active Control Group)0.37± 0.11
Active SI TMS25 (Active Control Group)0.46± 0.12
Active SI TMS100 (Active Control Group)0.47± 0.11
Active Control TMS Null0.32± 0.10
Active Control TMS250.41± 0.12
Active Control TMS1000.42± 0.12
Sham Control TMS Null0.31± 0.12
Sham Control TMS250.38± 0.12
Sham Control TMS1000.40± 0.11
Active SI TMS Null (Sham Control Group)0.39± 0.10
Active SI TMS25 (Sham Control Group)0.42± 0.11
Active SI TMS100 (Sham Control Group)0.40± 0.10
EEG Tactile Evoked Response Potential (ERP) Secondary · 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

GroupValue95% CI
Active SI-Hand TMS Null - Hit Trials-0.7937± 0.8361
Active SI-Hand TMS Null - Miss Trials-0.2330± 0.4005
Active SI-Hand TMS25 - Hit Trials-1.3684± 1.1736
Active SI-Hand TMS25 - Miss Trials-0.8988± 1.5002
Active SI-Hand TMS100 - Hit Trials0.0562± 0.8992
Active SI-Hand TMS100 - Miss Trials0.0727± 0.9644

Adverse events — posted to ClinicalTrials.gov

Time frame: 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).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MRI Only
Serious: 0/39 (0%)
Deaths: 0/39
Active SI-Hand TMS
Serious: 0/39 (0%)
Deaths: 0/39
Active Control TMS
Serious: 0/26 (0%)
Deaths: 0/26
Sham SI-Hand TMS
Serious: 0/13 (0%)
Deaths: 0/13
Other adverse events (3 terms — click to expand)

ReactionSystemMRI OnlyActive SI-Hand TMSActive Control TMSSham SI-Hand TMS
MigraineNervous system disorders
New psychiatric medicationPsychiatric disorders
New antibiotic medicationSkin and subcutaneous tissue disorders

Data from ClinicalTrials.gov NCT04062318 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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