This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Modulation of Sensory Acuity With Transcranial Magnetic Stimulation (TMS) (NCT05723575), a na na study. The primary outcome is Somatosensory Acuity: Spatial Amplitude Discrimination Threshold (SDT).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05723575 |
| Phase | NA |
| Condition | Speech |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 15 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Wisconsin, Madison |
| Results posted | Yes |
2. Clinical Question
Population
Healthy adult speakers across the lifespan, described in three age groups: 18-35, 36-55, and 56+. The registry record lists an enrollment of 15.
Intervention
Three sessions targeting primary somatosensory cortex: intermittent theta-burst stimulation (iTBS), continuous theta-burst stimulation (cTBS), and sham stimulation. The study also measures somatosensory acuity.
Comparator
The three stimulation conditions are listed as sessions for participants in a single group. The record does not describe randomized allocation or a separate control arm, so these conditions should not be treated as a randomized, like-for-like comparison.
Primary question
How does spatial amplitude discrimination threshold, measured as change in threshold in µm, relate to the study’s stimulation sessions? The registry record describes the outcome but does not report condition-specific results or an analysis of differences.
The study is intended to investigate how the brain processes and controls speech in healthy people. Its focus is a sensory measure rather than a clinical communication outcome. The registry rationale is that sensing tactile differences may be relevant to speech production and to noticing speech errors, while direct measurement of oral proprioception is difficult.
The listed outcome is the smallest difference in tongue-vibration amplitude that a participant can detect. Measurements are made with probes on the left and right sides of the tongue. The stated timeframe is up to 1 hour, but the record does not specify the precise measurement schedule relative to each stimulation session or what value is used as the reference for the reported change.
The clinical question is therefore best understood as a planned investigation of sensory acuity in healthy speakers under different stimulation conditions. The registry record does not report results that answer whether thresholds changed, how large any change was, or how precisely it was estimated.
3. Trial Design
This is a completed, single-group study sponsored by the University of Wisconsin, Madison. The registry lists the study as not applicable for phase and allocation, with no masking. It describes healthy adult speakers and an enrollment of 15. The stated study dates are 2022-11-18 for study start and 2023-05-26 for primary completion.
The study description says participants can expect 4 visits lasting 2-4 hours each. Participants complete three sessions targeting primary somatosensory cortex: one using intermittent theta-burst stimulation (iTBS), one using continuous theta-burst stimulation (cTBS), and one with sham stimulation. The registry does not state the order of these sessions, whether the order is counterbalanced, or how much time separates them. Those design details are not reported in the registry record.
The registry lists TMS as a device intervention and somatosensory acuity measurement as a behavioral intervention. It describes a primary outcome of spatial amplitude discrimination threshold, expressed as change in threshold in µm, with the timeframe stated as up to 1 hour. The record lists two outcome measures but does not report analyses for them.
A single-group design is important when interpreting the stated stimulation conditions. The registry does not identify separate randomized arms or a parallel control group, and its allocation field is listed as not applicable. Although sham stimulation is among the sessions, the record does not provide enough detail to treat the conditions as a randomized, masked comparison. In particular, the order and comparison method are not reported.
The record marks the study as completed, but completion status is not the same as availability of outcome results. The registry record does not report threshold values, estimates of change, uncertainty intervals, or statistical tests. It therefore describes the intended design and measurement without establishing what the study observed.
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.
Overall Study
| Stage | Healthy Adult Speakers |
|---|---|
| STARTED | 15 |
| COMPLETED | 15 |
| NOT COMPLETED | 0 |
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.
| Characteristic | Unit | Healthy Adult Speakers |
|---|---|---|
| Participants analysed | 15 | |
| Age, Continuous | years | 25 (18 to 39) |
| Sex: Female, Male: Female | Participants | 8 |
| Sex: Female, Male: Male | Participants | 7 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 14 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 8 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 7 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 15 |
6. Primary Endpoint
The registry lists the primary outcome as Somatosensory Acuity: Spatial Amplitude Discrimination Threshold (SDT), measured over up to 1 hour.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Error |
| Unit | change in threshold (µm) |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is spatial amplitude discrimination threshold (SDT), expressed as change in threshold in µm. It represents the smallest difference a participant can detect in the amplitude of vibration applied to the tongue. The registry describes delivery of vibratory stimulation with a Brain Gauge device using two probes, one on each side of the tongue.
The endpoint is a measure of tactile acuity. The study uses tactile acuity as a proxy for full somatosensation because measuring proprioception in the oral system is difficult. The registry also gives a rationale connecting tactile input with speech production: tactile contact is maintained parasagittally during vowel production, and tactile deprivation is described as leading to imprecise speech movements. These statements explain the research motivation; they are not results from this study.
The outcome is continuous, and the listed summary parameter is the mean, with standard error as the dispersion measure. A mean describes the average measured threshold change in a group. A standard error describes the precision of an estimated mean, rather than the spread of individual measurements. The timeframe is listed as up to 1 hour.
The word “change” requires a reference point to be interpreted. The registry record does not specify the reference measurement, the exact timing of measurement relative to stimulation, or the calculation used to form the change score. It also does not report observed endpoint values. The measurement description therefore clarifies what the endpoint is intended to capture, but not the size or direction of any observed change.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a planned continuous sensory outcome but does not report its results. No mean threshold changes, standard errors, confidence intervals, or condition-specific estimates are available in the record. As a result, the direction, magnitude, and precision of any observed change cannot be described from the registry information.
The listed enrollment is 15, and the study is marked completed. These registry entries do not establish how many participants contributed usable data to the primary endpoint. The registry record does not report analysis populations, participant-level exclusions, missing measurements, or the number of observations included in any estimate. Completion status should not be read as evidence that all planned measurements were collected or analyzed.
The study includes iTBS, cTBS, and sham stimulation sessions within a single group. This is not documented as a randomized comparison with separate arms. Any differences between session measurements, if they were measured, could require careful interpretation in light of session order, learning, fatigue, or other time-related influences. The registry does not report the session order, control of these influences, or the statistical approach used to compare conditions. These are uncertainties, not evidence that such influences occurred.
The endpoint’s standard error, if reported, would describe precision of the estimated mean; it would not by itself describe the spread of individual participants’ responses. A confidence interval, if available, would give a range of values compatible with the data under the method used. Neither such interval nor its underlying estimate is reported in the registry record. Statistical significance, clinical importance, and consistency across age groups therefore cannot be assessed from the information recorded.
The registry lists two outcome measures but no analyses. This means the registry record does not contain a documented analysis for these outcomes. It does not establish whether analyses were performed outside the record or whether results were posted elsewhere. No conclusion about the effectiveness of any stimulation condition follows from the absence of registry results.
The posted planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect defined as a stated fraction of the observed effect. Those assumptions describe a planning illustration, not the study’s documented design. The study is recorded as single-group, and no observed effect is reported. Any sample-size illustration based on those assumptions should not be interpreted as observed power or as evidence about the study’s findings.
Overall, the record supports a description of the research question, outcome definition, and broad design. It does not support a quantitative account of what the study found. The distinction between a completed study and a study with posted outcome estimates is essential: status alone cannot replace results or their uncertainty.
9. Statistical Methods Explained
The primary measure is continuous: a threshold in µm, summarized as a mean. A continuous outcome can take values across a scale, rather than being limited to categories such as present or absent. The mean gives an average for the observations included in a calculation. Its interpretation depends on which observations are included and how each participant’s measurement is formed. The registry record does not report those analysis details or the observed values.
What does the standard error describe?
The registry lists standard error as the dispersion measure for the mean. In general, standard error describes the precision of an estimated mean: it reflects how much that estimate would vary across repeated samples under the assumptions of the analysis. It is not the same as the standard deviation, which describes variability among individual observations. A small standard error can coexist with substantial participant-to-participant variability, and a standard error alone does not show the full distribution of individual responses.
Precision also depends on the data and the analysis. For a repeated-measures study, observations from the same participant are generally related rather than independent. An analysis that compares conditions would need to account for that structure. The registry describes multiple sessions in one group, but it does not report the statistical model, whether participant-level pairing was used, or how repeated observations were handled. No particular model or test can therefore be attributed to this study from the record.
How should a change score be understood?
A change score compares a measurement with a defined reference measurement. The reference could be a prior measurement or another specified value, but the registry record does not say which reference is used. Without that definition, the direction and interpretation of a reported change would be ambiguous. The record also does not specify whether changes are calculated separately for each stimulation session or summarized in another way.
In general, a comparison of means can be accompanied by a confidence interval. Such an interval expresses uncertainty about the estimated quantity, under the statistical model and method used. It is not a range containing a fixed proportion of individual measurements, nor does it prove that any particular value is true. The registry record does not provide a confidence interval or describe an inferential procedure, so no interval-based conclusion is available.
What can a significance test establish?
In general, a significance test evaluates how compatible observed data are with a specified null hypothesis under assumptions. A p-value is not the probability that the null hypothesis is true, and it does not measure the size or practical importance of an effect. Interpretation requires knowing the hypothesis, model, test, and analysis population. The record lists no analyses, test results, or p-values, so no significance statement can be made about the sensory outcome.
The sample-size assumptions associated with the planning illustration specify a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They also describe detecting a stated fraction of the observed effect. These are planning assumptions, not reported features of the registry’s single-group design. Because an observed effect is not reported in the registry record, those assumptions do not establish what effect was observed or how likely the study was to detect it. Planning illustrations are not observed power.
The two-arm, equal-allocation assumption is especially important to distinguish from the actual study description. The record lists three stimulation sessions in a single group, rather than two parallel arms. A calculation based on two arms cannot be taken as a description of how participants were allocated in this study. The record does not provide a study-specific sample-size justification, and none should be inferred from the planning assumptions.
Does over-dispersion matter for this endpoint?
Over-dispersion is a general concern in some count-data models when observed variability exceeds what the model assumes. It can make uncertainty estimates too narrow if ignored. The primary endpoint is a continuous threshold, not a count outcome, so count-model over-dispersion is not the central issue for interpreting this measure. The relevant questions instead include the distribution of threshold measurements, the relationship among repeated measurements within participants, missing observations, and the chosen comparison method. The registry record does not report how these matters were assessed.
More broadly, a statistical method should match the design and the question. A single-group set of sessions may involve within-participant comparisons, but the record does not document whether such comparisons were planned or performed. Without the analysis plan and results, it is not possible to evaluate model assumptions, estimate uncertainty, or assess whether a reported conclusion follows from the data.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures and no analyses. It does not describe a multiplicity strategy, such as how interpretation would account for testing more than one outcome or making several comparisons among stimulation sessions. Whether adjustment is needed depends on the actual hypotheses and analysis plan; that plan is not reported in the registry record. No adjustment method or multiplicity-controlled result can be inferred.
Missing-data handling is also not reported in the registry record. The listing does not state whether measurements were missing, how missing observations were handled, or whether any sensitivity analysis was conducted. The enrollment figure and completed status do not show how many participants had usable measurements for each outcome. A reader therefore cannot assess whether missingness could have affected an estimate.
The registry record does not define an analysis population, such as all enrolled participants or participants with complete measurements. It also does not report exclusions, deviations, or the number of observations used in an analysis. These details matter because a mean describes the data included in its calculation, not automatically everyone enrolled.
The absence of posted analyses is not proof that no analyses were performed outside the registry. It means the registry record does not provide the information needed to assess outcome selection, missingness, or the population analyzed. These uncertainties limit interpretation independently of the study’s completed status.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Healthy Adult Speakers | 0 | 15 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Healthy Adult Speakers | 0 of 15 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Healthy Adult Speakers | 0 of 15 |
The adverse-event figures list 15 participants at risk for serious adverse events and 0 affected. The separate figures for other adverse events also list 15 at risk and 0 affected. The registry lists 0 deaths. No serious adverse-event terms are listed.
These are registry counts, not a complete account of safety monitoring. A count of 0 affected means no events are recorded in the corresponding field; it does not establish that every possible event was assessed, that reporting was complete, or that an event could not occur. The registry record does not provide event definitions, collection procedures, severity details, or an observation period for adverse events.
The at-risk figures should not be treated as confirmation that each participant completed every session or contributed outcome data. Nor do the counts determine whether an event was related to TMS or another study procedure; the record does not report such an assessment. The appropriate reading is narrow: the registry lists no serious adverse events, no other adverse events, and no deaths in the displayed group-level counts.
12. What the Result Does, and Does Not, Mean
This study addresses a research question about sensory processing in speech by measuring the ability to detect differences in tongue-vibration amplitude. It uses this tactile acuity measure as a proxy for broader somatosensation and includes sessions with iTBS, cTBS, and sham stimulation. The design and endpoint description indicate what investigators intended to examine, not what the data demonstrated.
The registry record does not report observed threshold changes or statistical analyses. It therefore cannot establish whether sensory acuity changed during any session, whether conditions differed, or how uncertain any estimate might be. There is no basis in the registry record for claiming benefit, lack of benefit, or a causal effect of stimulation.
The study is described as involving healthy adult speakers across the lifespan, with three age groups listed. The record does not report age-specific estimates or comparisons, so it cannot establish whether outcomes differ by age group. It also does not report a separate clinical population with communication disorders. The stated potential relevance to communication disorders is a research rationale, not evidence of an effect in people with those disorders.
Even if numerical results were available, their interpretation would depend on how change was defined, how session order and repeated observations were handled, what participants contributed data, and what uncertainty accompanied each estimate. The registry record does not provide these details. The completed status and the listed adverse-event counts do not fill that gap.
The most defensible conclusion is about the scope of the record: it documents a completed single-group study and its planned sensory measurement, but does not provide findings with which to judge the research question. The absence of posted results is not evidence for either a positive or a null effect.
13. Why This Trial Matters Statistically
This study illustrates why the design, endpoint, and results need to be read together. A measured change in a continuous threshold has meaning only when its reference point and timing are clear. The record identifies the measure and its broad timeframe, but does not specify the reference used to define change. That limits interpretation even before considering statistical significance.
The study also demonstrates the distinction between a single-group set of sessions and a randomized comparison. iTBS, cTBS, and sham are all listed, but allocation is not described as randomized and there is no separate arm structure. Session order and the method of comparing measurements are not reported. A planning calculation framed around equal allocation to two arms should therefore not be mistaken for the study’s actual design.
Reporting uncertainty is another central statistical issue. The endpoint is summarized as a mean with standard error, but no observed estimate or uncertainty measure is reported. Without results, readers cannot judge the size or precision of any change. The enrollment count and completed status do not substitute for estimates, analysis populations, or information about missing observations.
Finally, registry completeness matters. The record lists two outcome measures but no analyses, and it does not document handling of multiplicity or missing data. These omissions do not show that investigators failed to conduct analyses; they mean those analyses cannot be evaluated from the registry record. For clinical and statistical interpretation, a clear account of estimates, uncertainty, and analysis methods is necessary to move from a research question to evidence about what was observed.
14. 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 registry record does not report the primary outcome values, condition-specific estimates, confidence intervals, or inferential results. This is the main limitation for interpreting the study: the research question and measurement are described, but the observed effect and its precision are unavailable.
The study is listed as single-group, with no allocation and no masking. Although the three sessions include sham stimulation, the record does not state session order, whether order was counterbalanced, or how comparisons were planned. It is therefore not possible to assess from the registry record how the design addressed possible order or period effects, or how a within-participant comparison was analyzed.
The endpoint is described as change in threshold, but the reference measurement and calculation details are not reported. The record also does not specify the number of measurements per session, the timing relative to stimulation, or how left- and right-side probe measurements contribute to the endpoint. These details could affect what a mean change represents.
The registry lists enrollment of 15 but does not report the number analyzed for each outcome, missing measurements, exclusions, or analysis populations. It also does not document the statistical model, assumptions, multiplicity handling, or a study-specific sample-size justification. The separate planning assumptions involving two arms do not resolve these questions and do not match the listed single-group design.
Finally, the population is healthy adult speakers. The registry record does not report outcomes by age group or findings in people with communication disorders. The stated possible relevance to communication disorders should not be interpreted as direct evidence in those populations.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Modulation of Sensory Acuity With Transcranial Magnetic Stimulation (TMS) — NCT05723575.
- Registry record last updated 2024-12-17; status last verified 2024-11.
- Results first posted 2024-12-17.
- 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.
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18. Record Summary
The registry describes a completed, single-group study of TMS and somatosensory acuity in healthy adult speakers. The sponsor is the University of Wisconsin, Madison, and enrollment is listed as 15. Participants are described across age groups 18-35, 36-55, and 56+.
The study includes iTBS, cTBS, and sham sessions targeting primary somatosensory cortex, along with measurement of tongue-vibration discrimination. The primary endpoint is change in spatial amplitude discrimination threshold in µm, summarized as a mean with standard error; its timeframe is up to 1 hour. The study description anticipates 4 visits lasting 2-4 hours each.
The registry record does not report outcome results or analyses. It lists no serious adverse events, other adverse events, or deaths in the recorded counts. Session order, analysis populations, missing-data handling, and the statistical analysis method are not reported in the registry record.