Beta Events and Sensory Perception: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Beta Events and Sensory Perception (NCT04062318), a randomized na study. The primary outcome is Threshold-Level Tactile Detection Hit Rate.

2. Clinical Question

3. Trial Design

The registry describes a completed randomized, single-masked crossover study of TMS and tactile perception. Enrollment was 39. The study combines MRI, EEG, non-invasive brain stimulation using TMS, and computational neural modeling, according to its brief summary. The listed conditions are Beta Rhythm and Tactile Perception, and the listed phase is NA.

The primary outcome concerns participants’ detection of threshold-level tactile stimuli delivered to the third digit of the right hand. Participants indicated detection or non-detection by button press. During the task, EEG was recorded and TMS could be applied at specified times relative to a tap or not applied on that trial. The registry describes active SI-Hand, active control, and sham control TMS conditions. It states that outcome assessments occurred during an active SI session and either an active control or sham control session, with sessions at least 1 week apart.

The crossover structure means participants could contribute observations under more than one condition, allowing within-person comparisons in the intended analysis. The available endpoint group counts are smaller than the total enrollment: the active-control comparisons list 20 participants and the sham comparisons list 9. The registry explains that only participants who completed two sessions were included in the within-subject analysis. The precise reasons for non-completion, the sequence allocation, and the full masking details are not reported in the registry record.

The record lists 2 outcome measures and 15 analyses overall. It lists an EEG tactile evoked response potential as a secondary outcome. The registry record does not report the original sample-size justification, a full statistical analysis plan, or details of any interim analyses.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: 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.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: The numbers of participants analyzed in this section are lower than the number in the 'baseline characteristics' section because only participants who completed two sessions (Active SI-Hand TMS and a control session) were included in the within-subjects analysis. One subject completed both control conditions, and it counted in both the 'Active Control Group' and the 'Sham Control Group'.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Threshold-Level Tactile Detection Hit Rate, measured over 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..

The primary endpoint, Threshold-Level Tactile Detection Hit Rate, measures the share of tactile-stimulus trials on which participants correctly reported detecting the tap. The registry defines a hit as a correctly detected tactile stimulus and describes the rate as hits divided by the total number of trials on which a tactile stimulus was presented. Trials without a tactile stimulus are not part of that definition.

Participants received either one tactile stimulus or no stimulus per trial and reported detection or non-detection by button press. The stimulus intensity was individually set at a perceptual threshold, described as being perceived roughly half the time. This setup makes hit rate a direct measure of detection responses under the task conditions, rather than a measure of general sensory ability outside the experiment.

The endpoint is reported as a mean with standard deviation. The comparison conditions include TMS 100 msec before the tap, TMS 25 msec after the tap, and no TMS on the trial. These conditions were assessed during the active SI-Hand session and during an active-control or sham-control session. The registry record uses hit rate because the study asks how TMS timing and stimulation condition relate to tactile detection on threshold-level trials. A hit rate alone does not capture every aspect of performance, such as false alarms on trials without a tap; those are not the primary endpoint described in the record.

7. Results Posted in the Registry

• Active SI TMS25 (Active Control Group): mean 0.46 versus 0.37 on control; difference 0.09 (95% CI 0.02 to 0.16), standardized effect d = 0.78; z-test p = 0.013.
• Active SI TMS100 (Active Control Group): mean 0.47 versus 0.37 on control; difference 0.10 (95% CI 0.03 to 0.17), standardized effect d = 0.91; z-test p = 0.004.
• Active Control TMS Null: mean 0.32 versus 0.37 on control; difference -0.05 (95% CI -0.12 to 0.02), standardized effect d = -0.48; z-test p = 0.133.
• Active Control TMS25: mean 0.41 versus 0.37 on control; difference 0.04 (95% CI -0.03 to 0.11), standardized effect d = 0.35; z-test p = 0.272.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

EEG Tactile Evoked Response Potential (ERP)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Active SI-Hand TMS Null - Miss Trials: mean -0.23 versus -0.79 on control; difference 0.56 (95% CI 0.13 to 0.99), standardized effect d = 0.86; z-test p = 0.010.
  • Active SI-Hand TMS25 - Hit Trials: mean -1.37 versus -0.79 on control; difference -0.57 (95% CI -1.24 to 0.09), standardized effect d = -0.56; z-test p = 0.091.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Active SI-Hand TMS Null - Miss Trials than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Active SI-Hand TMS25 - Hit Trials and the control. The interval gives the range of effects that remain compatible with the data.

The secondary endpoint is EEG tactile evoked response potential, reported as EEG signal amplitude in microvolts. The posted summaries distinguish hit and miss trials and include the SI-Hand TMS Null, TMS25, and TMS100 conditions. The registry also reports selected two-sided t-tests comparing hit and miss trial groups. Across these summaries, the endpoint offers a view of EEG activity associated with the task and detection responses, alongside the behavioral hit-rate outcome.

The secondary results do not independently settle the primary question. They concern a different measurement and a different aspect of the task, and the registry record does not report a prespecified analysis hierarchy linking the EEG outcome to the primary hit-rate endpoint. They may be relevant for describing patterns that could be investigated further, but they should not be treated as confirmation of a primary endpoint contrast or as evidence of a mechanism on their own.

Unadjusted secondary results carry less weight because the registry lists numerous analyses and does not report a multiplicity-control plan. General explanation: when many tests are performed, some may appear notable by chance even if there is no corresponding underlying effect. Without a stated plan identifying primary and secondary hypotheses or controlling the overall testing error, isolated secondary p-values require cautious interpretation.

The endpoint summaries report means and standard deviations, but participant-level pairing and the full analysis model are not reported in the registry record. The same limitations that affect interpretation of the primary crossover outcome may also matter for EEG comparisons. The secondary results are best read as additional descriptive and exploratory evidence, interpreted in context rather than as a separate definitive test of the study’s broad causal objective.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• EEG Tactile Evoked Response Potential (ERP)

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: it is a hit rate averaged across trials and summarized by a mean and standard deviation. A mean describes the central value of the observations, while a standard deviation describes how spread out the observations are around that mean. General explanation: the standard deviation is not the uncertainty in the estimated mean; uncertainty in a mean difference is commonly expressed with a confidence interval or a standard error.

The registry reports two-sided t-tests for listed pairwise comparisons. General explanation: a two-sided test evaluates whether the data are compatible with differences in either direction, rather than testing only whether one named condition is higher. A p-value describes how unusual the test statistic would be under the test’s null model. It is not the probability that the null hypothesis is true, and it does not quantify the size or practical importance of an observed difference.

The posted pairwise results include comparisons between TMS timing conditions within the active-control and sham-control groupings. The registry record does not describe the complete statistical model behind those tests, nor does it say whether the tests were planned in advance. The record also does not state whether the tests were adjusted for the number of comparisons. Because multiple comparisons can increase the chance of finding at least one apparently unusual result, unadjusted tests should be interpreted as exploratory unless an adjustment strategy is documented.

The crossover design is important when interpreting a comparison. General explanation: a paired or within-person analysis uses the fact that the same participant contributes data under more than one condition. It can account for the association between a participant’s responses across conditions. That association affects the standard error of a within-person difference. The posted group means and standard deviations do not contain the individual participant pairings or their covariance, so a simple recalculation from those summaries cannot reconstruct every feature of a paired analysis. The registry record does not report enough detail to determine how period, order, or carryover effects were handled.

The recalculated mean differences are simple unadjusted calculations from posted summary statistics. Their confidence intervals represent uncertainty under that recalculation, not necessarily uncertainty from the sponsor’s crossover analysis. Since the discrepancy flag is true, the sponsor’s own analysis takes precedence. The recalculations can help readers understand the direction and approximate size of selected contrasts, but they should not be treated as a replacement for the analysis reported by the study sponsor.

General explanation: a confidence interval gives a range of values compatible with the data and the assumptions of the method used to construct it. A confidence interval that includes no difference is commonly described as not excluding the null value at the corresponding confidence level. A confidence interval that does not include that value suggests the data are less compatible with a no-difference model under those assumptions. Neither result alone establishes causality, importance, or reproducibility.

The registry reports standard deviations for the endpoint groups, but the outcome is bounded as a rate. General explanation: when a measure is bounded, its distribution may not be well represented by a normal model, particularly near the boundaries or with highly uneven responses. The registry record does not report diagnostic checks or a model for the trial-level binary detection responses. It therefore is not possible from the record alone to assess whether a model tailored to binary trial outcomes was considered or whether the reported mean-based tests were checked against alternative methods.

The record identifies only participants who completed two sessions as eligible for the within-subject endpoint analysis. It does not provide a complete account of the analysis population, missing-data handling, or reasons for all exclusions. General explanation: excluding participants with incomplete sessions can affect the composition of the analyzed group if completion is related to participant characteristics or responses. Without details about missingness and the analysis population, that possibility cannot be evaluated.

The posted EEG endpoint is also continuous and is reported as an EEG signal amplitude in microvolts, summarized by means and standard deviations. Its comparisons include hit and miss trials under different TMS timing conditions. General explanation: secondary analyses can help characterize possible mechanisms or patterns, but a large number of outcomes and contrasts increases the risk of chance findings when multiplicity is not addressed. The registry record does not report a hierarchy or multiplicity-control plan for the secondary analyses.

Finally, a p-value is not a measure of precision or effect size. General explanation: the estimated difference and its confidence interval describe the size and uncertainty of a contrast, while the p-value addresses compatibility with a specified null model. Readers should consider the point estimate, interval, design, sample size, and analysis assumptions together. In this study, incomplete reporting about paired-data handling and multiplicity limits how definitively the posted tests can be interpreted.

11. Confidence Intervals and Precision

The recalculated primary comparisons report mean differences and confidence intervals for selected conditions. The intervals for SI TMS25 and SI TMS100 versus SI TMS Null in the active-control group lie above zero. The intervals for the recalculated active-control comparisons include zero. These intervals are based on simple unadjusted recalculations from posted summary statistics, not a reconstruction of the sponsor’s full crossover analysis.

General explanation: a confidence interval represents a range of effect values that are reasonably compatible with the observations and the assumptions used in its calculation. A narrower interval indicates greater precision under those assumptions; a wider interval indicates more uncertainty. An interval that includes zero does not prove that there is no difference, and an interval that excludes zero does not establish that the difference is important or attributable to the intervention.

Precision is limited by the analyzed group sizes: the primary active-control summaries list 20 participants per condition, while the sham summaries list 9. The record explains that fewer participants entered the within-subject analysis than were enrolled because only participants completing two sessions were included. Individual paired responses and their covariance are not reported, so the recalculated intervals cannot reflect the full information that may be available to a paired analysis.

The discrepancy flag matters when reading these intervals. The sponsor’s own analysis takes precedence over the simple recalculations. The posted registry tests and the recalculated intervals should therefore not be treated as interchangeable evidence. The registry record does not report the sponsor’s confidence intervals for the primary pairwise tests, so the precision of the sponsor’s own estimated contrasts is not reported in the registry record.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm, not total events. This is a continuous-outcome planning illustration based on an observed effect, not the trial’s original design calculation. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is set to the stated fraction of the observed effect. The trial’s own original sample-size assumptions are not reported in the registry record.

The 80% power column gives the illustrative number of participants per arm for a design with an 80% chance of detecting the specified effect under those assumptions, if that effect and the planning model were correct. The 90% power column gives the corresponding number per arm for a design with a 90% chance. These are prospective planning quantities, not descriptions of the probability that the completed study found a real effect.

Rows that plan for 100% of the observed effect use the full observed contrast as the target; the 75% and 50% rows use smaller target effects. Smaller effects need more participants to detect with the same target power, as the planning figures illustrate. The entries are planning illustrations, not observed power.

These calculations are useful for understanding how a future study’s required size can change with the effect it aims to detect. They are not a justification for the enrollment in this trial, because the original design assumptions are not reported in the registry record. They also rely on simplifying assumptions, including equal allocation and a normal approximation, and should not be mistaken for a design analysis that accounts for all features of the randomized crossover study.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 0.090; pooled standard deviation σ = 0.115.
2. n = 2 × (1.96 + 0.842)² × 0.115² / 0.090² = 25.7, rounded up to 26 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 0.09                      # observed difference in means
sigma <- 0.115108644332213                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(4062318)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 26 (80% power), 35 (90% power)
 75% of observed effect: n per arm = 46 (80% power), 62 (90% power)
 50% of observed effect: n per arm = 103 (80% power), 138 (90% power)
power.t.test: 26.7 
Simulated power at n = 26 per arm: 0.792 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The registry reports sponsor analyses using two-sided t-tests for selected pairwise comparisons. Those are the study’s posted inferential results. Separate recalculations use the posted group means and standard deviations to estimate unadjusted mean differences, confidence intervals, and related planning illustrations. The registry discrepancy flag is true; the sponsor’s own analysis takes precedence over these recalculations.

The distinction is particularly relevant because the study is described as a crossover with within-subject analyses. Simple calculations from group summaries cannot recover the participant-level pairing or within-person covariance. The registry’s posted analysis may use information not available in those summaries, but the precise test implementation and model details are not reported in the registry record. It is therefore not possible to identify the exact source of the discrepancy from the record alone.

The sponsor’s reported t-test results should be read as the primary posted statistical evidence, while the recalculations are transparent, unadjusted checks based on summary data. Neither set of results resolves the unreported questions about multiplicity, prespecification, missing-data handling, or session effects. The recalculated estimates are useful for describing approximate contrasts, but they should not override the sponsor’s analysis or be presented as an exact reproduction of it.

15. Multiplicity, Missing Data and Analysis Populations

The registry record lists 15 analyses overall and reports multiple pairwise comparisons for the primary and secondary outcomes. It does not report whether the sponsor prespecified a testing hierarchy, adjusted p-values or confidence intervals for multiplicity, or designated some comparisons as exploratory. Without that information, the reported p-values should not be assumed to control the chance of false-positive findings across all analyses.

The record also does not report a complete statistical analysis plan, including the exact model for the crossover design, adjustment for session or period effects, or treatment of possible carryover. The trial is identified as randomized and crossover, but the randomization sequence, allocation details, and full masking procedure are not reported in the registry record. These details matter for understanding how the design was implemented and what assumptions support the comparisons.

The outcome population is smaller than enrollment. The registry explains that only participants who completed two sessions were included in the within-subject analysis. It does not report a full accounting of incomplete sessions, the reasons for non-completion, the handling of missing endpoint values, or whether any imputation was performed. The active-control summaries list 20 participants and the sham summaries list 9; the record does not provide enough information to determine how those analysis sets were formed beyond the stated two-session criterion.

General explanation: missing-data methods rely on assumptions about why observations are absent. If missingness is related to responses or participant characteristics, analyses limited to completers can differ from analyses of everyone enrolled. The registry record does not provide enough detail to assess that risk. It also does not report whether sensitivity analyses explored alternative missing-data assumptions.

These reporting gaps do not show that the analyses were inappropriate; they limit what can be independently evaluated from the registry record. In particular, the combination of multiple contrasts, incomplete reporting of the analysis plan, and unavailable participant-level paired data means that the posted findings should be interpreted as the results reported for the analyzed participants rather than as a fully reconstructible analysis.

16. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry reports serious adverse events for the listed groups as zero among 39 participants in MRI Only, zero among 39 in Active SI-Hand TMS, zero among 26 in Active Control TMS, and zero among 13 in Sham SI-Hand TMS. Deaths are reported as zero in each group.

Other adverse events are reported as zero among 39 in MRI Only, zero among 39 in Active SI-Hand TMS, 1 among 26 in Active Control TMS, and 2 among 13 in Sham SI-Hand TMS. These figures describe the registry’s counts and denominators for the listed groups. The group sizes differ, and they should not be treated as if every participant contributed to every condition or as direct evidence of comparative risk.

The record lists no serious adverse event terms. The available figures do not provide event descriptions, timing, severity details for the other events, or an assessment of whether events were related to study procedures. They are a summary of reported counts, not a basis for medical advice or a complete safety evaluation.

17. What the Result Does, and Does Not, Mean

The posted primary outcome describes how often participants reported detecting threshold-level tactile stimuli under the study’s TMS conditions. In the active-control comparison group, mean hit rates were higher in the timed SI TMS conditions than in the SI TMS Null condition, and the sponsor’s posted tests report differences for those comparisons. The active-control conditions show a similar descriptive pattern across timing conditions. These findings characterize task performance in the analyzed participants and under the conditions described in the registry.

They do not, by themselves, demonstrate that a specific brain rhythm caused the observed changes in tactile detection. The registry’s broader aim concerns a causal role for low-frequency rhythms, but the posted endpoint summaries and tests are only part of that research question. Comparisons across active SI-Hand, active control, and sham conditions, along with the EEG outcome and full analysis details, would be needed to understand the evidence in context. The record does not report enough statistical detail to establish how all such comparisons were integrated.

Nor do these results establish a general effect beyond the studied task, participants, and procedures. The endpoint reflects a button-press detection response to threshold-level tactile stimuli on experimental trials. The analyzed groups were smaller than total enrollment, and the sham summaries were based on 9 participants. The registry record does not report enough detail to assess representativeness or the effects of incomplete sessions.

The sponsor’s own analysis takes precedence over the simple recalculations, because the registry indicates a discrepancy. The posted data should therefore be understood as a report of specific condition comparisons with limitations in precision, multiplicity reporting, and reproducibility from summary statistics. They do not constitute medical guidance, and they do not show whether any stimulation approach should be used outside the research setting.

18. Why This Trial Matters Statistically

This trial is statistically interesting because it combines a randomized crossover design with measurements collected during a threshold-level sensory task. A crossover can make within-person comparisons informative: each participant may contribute observations under more than one condition, reducing the influence of stable differences between participants when the analysis is appropriately paired. At the same time, that structure makes participant-level pairing and session details important for evaluating uncertainty.

The endpoint is a rate derived from trial-level detection responses, but the posted summaries present means and standard deviations. This makes the registry results accessible while leaving questions about the distribution of trial responses and the precise analysis model unanswered. The sponsor’s reported tests and the simple recalculations do not fully coincide, underscoring why details of the statistical plan and paired-data analysis matter.

The study also includes EEG measurements alongside behavioral responses. That combination can motivate mechanistic hypotheses, but it brings multiple outcomes and comparisons that need careful planning and interpretation. The registry lists many analyses and does not report a multiplicity strategy. Statistical conclusions are therefore shaped not just by individual p-values, but by the number of tests, the analysis population, the design, and the precision of the estimates.

Finally, the registry makes visible the difference between total enrollment and the smaller groups contributing to endpoint analyses. That distinction is essential when assessing how much information a study contains. The study illustrates why readers should examine the estimand, the design, the analysis population, and uncertainty together rather than relying on a single test result.

19. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The outcome summaries do not include participant-level data, so the within-person covariance needed to reproduce a paired crossover analysis is not available. The registry discrepancy flag is true, and the sponsor’s own analysis takes precedence over the simple recalculations. The exact reason for the discrepancy is not reported in the registry record.

The analysis population is also incompletely described. The registry says that only participants completing two sessions were included in the within-subject analysis, while the endpoint summaries list 20 participants for active-control comparisons and 9 for sham comparisons. Reasons for incomplete sessions, exclusion details, and missing-data methods are not reported in the registry record. This limits assessment of how the analyzed participants compare with the full enrollment of 39.

The registry record does not report the original sample-size justification or the exact prespecified statistical analysis plan. It also does not report the handling of multiple comparisons, session or period effects, potential carryover, or the randomization sequence. These omissions make it difficult to assess which findings were primary hypotheses and how the crossover structure was incorporated into each test.

The behavioral endpoint is a hit rate, but the record does not report a model of trial-level detection responses or diagnostics for the distribution of the summarized measure. The sham comparisons involve 9 participants, which limits the amount of information in those summaries. The EEG outcome adds useful context, but its multiple comparisons and relationship to the primary outcome are not fully described.

These limitations concern what can be evaluated from the registry record. They do not establish that the study’s analyses were invalid, but they constrain independent reproduction and the strength of conclusions that can be drawn from the posted summaries.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Beta Events and Sensory Perception — NCT04062318.
• Registry record last updated 2026-02-23; status last verified 2025-09.
• Results first posted 2026-02-23.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

23. Record Summary

NCT04062318, Beta Events and Sensory Perception, is listed as completed and randomized, with single masking and a crossover model. Enrollment was 39. The study examined threshold-level tactile detection during active SI-Hand, active control, and sham TMS conditions, with an EEG tactile evoked response potential listed as a secondary outcome.

The primary endpoint is mean hit rate. The registry reports condition summaries and two-sided t-tests, while simple recalculations provide unadjusted comparisons from summary statistics. Because the discrepancy flag is true, the sponsor’s own analysis takes precedence. The record explains that fewer participants contributed to the within-subject endpoint analyses because only participants completing two sessions were included.

The registry does not report the original sample-size justification, a complete statistical analysis plan, multiplicity handling, or full missing-data methods. The posted findings should be read as condition-specific results with these reporting and precision limitations.