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Basic Science NA Continuous Endpoint NCT05739994

Frontal and Parietal Contributions to Proprioception and Motor Skill Learning: Complete Statistical Analysis

This analysis examines a randomized, single-masked, parallel-group study of theta burst transcranial magnetic stimulation over two brain regions compared with sham stimulation. Its registered primary outcome is maze-tracing accuracy measured at four points during a session; numerical results for that outcome are not reported in the registry record.

Trial start: 2023-06-09  ·  Enrollment: 118  ·  Sponsor: Indiana University
Scope of this record

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 Frontal and Parietal Contributions to Proprioception and Motor Skill Learning (NCT05739994), a randomized na study. The primary outcome is Motor Skill.

118
Enrollment
NA
n/a
Arms
In the primary outcome
n/a
Effect
No re-analysis shown
n/a
95% CI
See limitations
FeatureRegistry value
ClinicalTrials.gov identifierNCT05739994
PhaseNA
ConditionBasic Science
AllocationRandomized
Design modelParallel
MaskingSingle
Enrollment118
Arms in the primary outcomen/a
Lead sponsorIndiana University
Results postedYes

2. Clinical Question

Population

People enrolled in the study of proprioception and motor skill learning. The registry record does not report eligibility criteria or participant characteristics, so the population cannot be described more specifically.

Intervention

The two active groups received theta burst transcranial magnetic stimulation (cTBS) over either the dorsolateral prefrontal cortex (DLPFC) or the supramarginal gyrus (SMG).

Comparator

The sham control group received sham theta burst transcranial magnetic stimulation over the vertex.

Primary question

How does maze-tracing movement accuracy change across the session in the groups receiving stimulation over DLPFC or SMG and the group receiving sham stimulation? The registry describes change in mean accuracy as reflecting learning, but does not report the outcome results or a specific statistical comparison.

3. Trial Design

This completed study is registered as a randomized, single-masked, parallel-group trial. It lists 118 participants enrolled and classifies the condition as Basic Science; its phase is listed as NA. The registry record gives a start date of 2023-06-09 and a primary completion date of 2024-12-19.

Three groups are described: cTBS over the dorsolateral prefrontal cortex (DLPFC), cTBS over the supramarginal gyrus (SMG), and sham cTBS over the vertex. Randomization indicates that assignment was intended to be random, but the method used to generate or conceal assignments is not reported in the registry record. The record identifies masking as single, but does not say which people were masked.

The primary outcome, Motor Skill, was assessed four times during the 2-hour main session: before cTBS, immediately after cTBS, after 40 trials of maze-tracing practice, and after 80 trials of practice. This schedule allows the outcome to be measured before and at several stages after stimulation and practice. The record does not specify how the timing of outcome measurements was handled in the statistical analysis.

The registry lists two outcome measures and four analyses. It does not describe the analytic methods, the allocation ratio, or the number enrolled in each group. Safety counts are listed for each group, but they should not be treated as the enrollment totals or as the analysis populations for the primary outcome.

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: During the familiarization session, after giving informed consent, participants experienced the transcranial magnetic stimulation (TMS) used in the main experiment. This was to make sure they were not bothered by the sensations before random group assignment. Of the 118 who enrolled, 25 found the TMS uncomfortable and were excluded. A further 6 withdrew due to scheduling conflicts, leaving 87 who received a group assignment.

Overall Study

StageDorsolateral Prefrontal Cortex (DLPFC)Supramarginal Gyrus (SMG)Sham Control Group
STARTED292830
COMPLETED272626
NOT COMPLETED224

Reasons for not completing this period:

ReasonDorsolateral Prefrontal Cortex (DLPFC)Supramarginal Gyrus (SMG)Sham Control Group
Withdrawal by Subject224

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.

Population: These are the participants who did the main session, where baseline measurements were made.

CharacteristicUnitDorsolateral Prefrontal Cortex (DLPFC)Supramarginal Gyrus (SMG)Sham Control GroupTotal
Participants analysed27262679
Age, Continuousyears25.2 (SD 7.0)22.5 (SD 3.6)23.1 (SD 4.2)23.6 (SD 5.3)
Sex: Female, Male: FemaleParticipants14161242
Sex: Female, Male: MaleParticipants13101437
Ethnicity (NIH/OMB): Hispanic or LatinoParticipants37414
Ethnicity (NIH/OMB): Not Hispanic or LatinoParticipants24192265
Ethnicity (NIH/OMB): Unknown or Not ReportedParticipants0000
Race (NIH/OMB): American Indian or Alaska NativeParticipants0000
Race (NIH/OMB): AsianParticipants9121132
Race (NIH/OMB): Native Hawaiian or Other Pacific IslanderParticipants0000
Race (NIH/OMB): Black or African AmericanParticipants1102
Race (NIH/OMB): WhiteParticipants14111237
Race (NIH/OMB): More than one raceParticipants3238
Race (NIH/OMB): Unknown or Not ReportedParticipants0000
Region of Enrollment: United Statesparticipants27262679
Edinburgh handedness inventoryunits on a scale89.2 (SD 10.7)85.2 (SD 16.5)78.4 (SD 18.9)84.3 (SD 16.1)
Resting Motor Threshold (RMT)Percent of max stimulator output (%MSO)49.3 (SD 9.7)50.7 (SD 8.6)50.3 (SD 8.0)50.1 (SD 8.7)

6. Primary Endpoint

The registry lists the primary outcome as Motor Skill, measured over Assessed 4 times during the 2-hour main session: Pre-cTBS ("Pre"), immediately post-cTBS ("Post1"), after 40 trials of maze-tracing practice ("Post2"), and after 80 trials of maze-tracing practice ("Post 3")..

ElementRegistry entry
Result typeMean
Measure of spreadStandard Deviation
UnitAccuracy (%)
Endpoint classificationContinuous Endpoint

The primary outcome is titled Motor Skill and is measured as accuracy, in percent, on a maze-tracing task. Accuracy is defined as the percentage of the movement path that falls within the maze. Participants traced the maze 10 times at three speed ranges; overall performance accuracy was the mean across those speed ranges. The registry says that a change in mean accuracy reflects learning.

Accuracy is a continuous measure: it can vary across a range rather than being limited to categories such as improved or not improved. A group mean describes the average observed accuracy, while the standard deviation describes how dispersed individual measurements are around that mean. These summaries can help characterize performance and variation, but do not by themselves show how much individuals changed or whether a difference between groups is precise.

The outcome was assessed before cTBS, immediately after cTBS, after 40 practice trials, and after 80 practice trials. Repeated measurement makes it possible to describe performance at different stages of the session. The registry record does not report numerical accuracy results, standard deviations, or a formal estimate comparing changes between groups. It therefore does not establish from the posted outcome information whether or how accuracy changed.

7. Why No Re-analysis Is Shown

Reported as posted, not recalculated. Primary outcome has several categories or time points; not reduced to one comparison. A result is recalculated only when the posted data support a clean two-arm comparison, so no result is shown beyond what the sponsor posted.

8. Statistical Interpretation

Clinical Biostats interpretation

The registry identifies a focused experimental question: whether motor skill, measured as maze-tracing accuracy, changes across a session in groups receiving cTBS over DLPFC or SMG and a group receiving sham stimulation. The design includes measurement before stimulation and at three later points, including after practice. This structure is relevant to a question about performance over time, but the design description alone does not reveal the observed pattern.

Numerical results for the primary outcome are not reported in the registry record. There are no group means, standard deviations, change estimates, confidence intervals, or p-values for Motor Skill in the registry entries. Without those results, the direction and size of any observed group differences cannot be assessed, nor can their statistical precision. The record also does not report which specific contrasts or time-point comparisons were tested.

Random assignment can support a comparison of groups, but a reader still needs the actual outcome estimates and details of the analysis to understand what the study observed. The registry record does not describe the randomization method, allocation ratio, or which people were masked. It also does not report the analysis population or how missing outcome measurements, if any, were handled. These omissions limit assessment of how closely an analysis represents the randomized groups and how sensitive it might be to incomplete measurements.

The safety information is separate from the primary motor-skill outcome. The record lists zero serious adverse events in each group and lists other adverse events by group. These counts describe the registry’s adverse-event categories; they do not show the effect of stimulation on maze-tracing accuracy. The safety counts alone also do not provide enough information to explain event types, timing, or possible relationships to the intervention.

Overall, the registry record describes a completed randomized study and a repeated measure of motor performance, but does not report the primary outcome results. A conclusion about the observed accuracy pattern or the precision of any treatment contrast is therefore not possible from these registry entries. This is a limitation of the information reported, not evidence that an effect was absent.

9. Statistical Methods Explained

What kind of outcome is Motor Skill?

The registered outcome is continuous and summarized as a mean with a standard deviation. In general, a mean is an average that can describe the central level of performance in a group. A standard deviation describes the spread of measurements around that mean; it is not the same as the uncertainty in the estimated mean. The registry identifies these summary measures but does not report their values for the primary outcome.

Accuracy is defined as the percent of movement path within the maze. The registry says overall performance was averaged across three speed ranges, after repeated tracing. A mean across speed ranges offers one summary of performance rather than separate accuracy results at each speed. The record does not report the speed-specific measurements or the method used to aggregate individual trials beyond that description.

What does repeated measurement add?

Measurements were scheduled at four points in the 2-hour main session: Pre-cTBS, immediately after cTBS, after 40 trials of maze-tracing practice, and after 80 trials of maze-tracing practice. In general, repeated measurements can show whether the outcome changes over time and whether the pattern differs between groups. They also create a statistical consideration: measurements from the same participant are usually related, rather than independent observations. An analysis should account for that dependence when estimating uncertainty. The registry record does not identify the method used to do so.

A comparison of group averages at a single time point asks a different question from a comparison of change over time. A group-by-time analysis, for example, can assess whether the pattern across assessment points differs between groups. This is a general description of an analysis option, not a claim about the method used in this study. The registry record does not specify whether the analysis compared final measurements, changes from baseline, patterns across time, or another quantity.

How should uncertainty be understood?

In general, a confidence interval expresses a range of values compatible with an estimate under the assumptions of the analysis. A narrow interval indicates greater precision than a wide interval, while an interval spanning values that would imply different interpretations may leave substantial uncertainty. A p-value addresses compatibility of the observed data with a specified null hypothesis under an analysis model; it does not measure the probability that a hypothesis is true or describe the size of an effect. No confidence intervals or p-values for the primary outcome are reported in the registry record, so these concepts cannot be applied to a numerical Motor Skill estimate.

Standard deviations and confidence intervals answer different questions. The former describes participant-level variability, while the latter describes uncertainty around an estimated quantity, such as a mean or contrast. Neither can be inferred from the other without additional information and assumptions. Because primary outcome summaries are absent, neither the amount of variability nor the precision of a group comparison can be evaluated.

What does randomization contribute?

In general, random allocation is intended to make comparison groups similar, on average, with respect to factors present before assignment. It does not guarantee that groups will be identical, and it does not eliminate the need to report outcomes and analytic choices. This record identifies the study as randomized, but the method of sequence generation, allocation concealment, and group assignment ratio is not reported in the registry record. The single-masked designation is present, but the identity of the masked parties is not specified.

How should planning illustrations be read?

Any sample-size planning illustration is a hypothetical calculation, not an observed result and not observed power. The stated assumptions for such illustrations are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect expressed as a fraction of the observed effect. For time-to-event outcomes, the stated convention is total events; for other outcomes, it is participants per arm. These are planning assumptions, not a description of the trial’s allocation or a substitute for its outcome results. The registry record does not report the trial’s own sample-size justification or statistical plan.

For a continuous outcome, a planning calculation depends on assumptions about the target effect and variability, among other choices. If the observed effect is used as a reference, smaller fractions of that reference represent smaller target effects. Such illustrations can help frame future study planning, but cannot establish that the current study had a particular probability of detecting an effect. The outcome estimates needed to evaluate the observed effect are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures and four analyses, but does not describe the relationship between those analyses and outcomes. The primary Motor Skill measure has four assessment points. Considering several time points, groups, outcomes, or contrasts can create multiplicity: the more questions tested, the greater the chance that some results may appear notable by chance when each is considered separately. In general, an analysis plan can address this by defining a primary contrast in advance or using an appropriate adjustment. The registry record does not report whether multiplicity was addressed or what comparisons were prespecified.

The record does not report how missing primary outcome measurements were handled, whether any participants lacked measurements at one or more time points, or whether the analysis used all randomized participants. These details matter because an analysis limited to participants with complete measurements can differ from one that retains participants with partial data. General statistical approaches to repeated measures may use available observations under particular assumptions, but no approach or assumption can be attributed to this study based on the registry record.

Similarly, the registry record does not report a primary analysis population, exclusions from analysis, or whether the analysis followed randomized assignment. Without these details, the reader cannot determine how missingness, exclusions, or multiple comparisons influenced the reported analyses. This uncertainty is separate from the absence of numerical Motor Skill results, which also prevents assessment of effect estimates and precision.

11. Safety Results

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

ArmParticipants with serious adverse eventsParticipants at riskPercentage
Dorsolateral Prefrontal Cortex (DLPFC)0280.0%
Supramarginal Gyrus (SMG)0280.0%
Sham Control Group0300.0%

Deaths

ArmDeaths (participants affected of at risk)
Dorsolateral Prefrontal Cortex (DLPFC)0 of 28
Supramarginal Gyrus (SMG)0 of 28
Sham Control Group0 of 30

Other (non-serious) adverse events

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

ArmParticipants affected of at risk
Dorsolateral Prefrontal Cortex (DLPFC)5 of 28
Supramarginal Gyrus (SMG)7 of 28
Sham Control Group6 of 30

Most frequent non-serious adverse event terms

Event termOrgan systemDorsolateral Prefrontal Cortex (DLPFC)Supramarginal Gyrus (SMG)Sham Control Group
Discomfort from TMSGeneral disorders4 of 287 of 285 of 30
HeadacheNervous system disorders1 of 280 of 281 of 30
Do not overextend the safety comparison. Serious-adverse-event counts are safety observations, not efficacy outcomes, and should not be combined with the primary result into a single benefit-risk number.

The registry record lists serious adverse events for the three groups. For DLPFC, 0 serious adverse events are listed among 28 at risk; for SMG, 0 are listed among 28 at risk; and for the sham control group, 0 are listed among 30 at risk. Deaths are listed as 0 in all three groups. The record lists other adverse events as 5 among 28 at risk for DLPFC, 7 among 28 at risk for SMG, and 6 among 30 at risk for sham control.

These are counts in the registry’s serious and other adverse-event categories. Zero recorded serious events does not establish that no adverse events of any kind occurred: the registry separately reports other adverse events. The record does not provide the terms for those other events, their severity, timing, duration, or assessed relationship to the intervention. It also lists no top serious adverse-event terms.

The at-risk counts are safety denominators and should not be assumed to describe the primary outcome analysis population. These descriptive counts do not, on their own, determine whether the groups differ in safety or explain the cause of any event. The registry record does not report a statistical comparison of adverse-event counts.

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

The study addresses how stimulation over DLPFC or SMG, compared with sham stimulation, relates to maze-tracing performance measured during a session that includes practice. Its basic-science focus is proprioception and motor skill learning. The registry summary says the information might help inform future rehabilitation protocols, but this study description alone does not establish a rehabilitation effect.

The available record identifies the trial design, intervention groups, outcome definition, measurement schedule, and some safety counts. It does not report the numerical primary outcome results. Consequently, the reported details do not show whether accuracy increased or decreased, whether patterns differed across groups, or how precisely any contrast was estimated. Missing results should not be interpreted as evidence that there was no change or no difference.

Even when outcome estimates are available, statistical evidence and practical meaning are separate considerations. A statistical comparison can address compatibility with a null hypothesis under specified assumptions, while the size and uncertainty of the estimate inform how much the data support a particular magnitude of difference. In general, the interpretation also depends on the measure, study population, design, and analysis. Here, the key outcome estimates and analysis details are not reported in the registry record.

The listed adverse-event counts provide a limited description of events in registry categories, not a complete account of the experience of participants or a measure of motor learning. The record does not report event descriptions or inferential comparisons. The findings therefore cannot be used to make a clinical recommendation. The registry summary frames potential relevance to future rehabilitation research as a possibility, rather than reporting a demonstrated rehabilitation outcome.

13. Why This Trial Matters Statistically

This study is statistically interesting because it combines randomized group assignment with repeated measurement of a continuous motor-performance outcome. The outcome is measured before stimulation and again immediately afterward and following two amounts of maze-tracing practice. This makes the question more specific than simply asking whether performance differs at one point: the scientific interest includes how accuracy changes during the session and whether those patterns vary by stimulation location or sham condition.

That structure also highlights why analysis details matter. Repeated measurements within a participant are related, and multiple groups and time points can support several possible comparisons. The estimated group pattern and its uncertainty depend on how an analysis accounts for that structure and which contrasts it treats as primary. The registry record does not report those methods or the numerical primary outcome results, so the statistical question is clear but the result cannot be evaluated from the listed details.

The study also distinguishes active stimulation at two brain locations from sham stimulation at the vertex. This design can organize a comparison around stimulation location and a sham control, but the record does not establish which statistical contrasts were intended or report their estimates. Reading the design carefully therefore prevents mistaking the research question for a demonstrated finding.

Finally, the registry separates the primary motor-skill outcome from adverse-event reporting. Keeping those outcomes distinct is important: safety counts do not answer the motor-learning question, and the motor outcome does not describe adverse events. Together, these features make the study a useful example of how a well-defined outcome schedule and an explicit comparator can coexist with limits on interpretation when results and analysis details are not reported.

14. Limitations

Several trial-specific details needed to assess the primary outcome are not reported in the registry record. These include numerical Motor Skill results by group and time point, estimates of between-group differences or changes, measures of precision, and the statistical tests used. The record also does not state which comparisons were primary among the possible group and time-point comparisons.

Important design details are also absent. Eligibility criteria, participant characteristics, the randomization procedure, the allocation ratio, and the identity of the masked parties are not reported in the registry record. The descriptions identify the brain regions targeted and the vertex sham location, but do not report detailed stimulation parameters or whether other aspects of the groups’ procedures differed.

The record does not describe the primary outcome analysis population, missing-data handling, exclusions, or multiplicity approach. It also does not give participant counts for the primary outcome analysis. The at-risk counts in the safety information should not be substituted for those details.

Although the registry identifies the study as completed and lists an enrollment figure, the information available does not permit assessment of outcome completeness, statistical precision, or the consistency of results across measurements. The study’s sample-size justification and statistical plan are not reported in the registry record. These gaps limit interpretation of the study’s primary question; they do not show that the study lacked a result or that the interventions had no effect.

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18. Record Summary

NCT05739994 is a completed randomized, single-masked, parallel-group study titled “Frontal and Parietal Contributions to Proprioception and Motor Skill Learning.” The registry lists enrollment of 118 and dates of 2023-06-09 for study start and 2024-12-19 for primary completion. Its condition is Basic Science and its phase is listed as NA.

The groups received cTBS over DLPFC, cTBS over SMG, or sham cTBS over the vertex. The primary outcome is maze-tracing accuracy, assessed at four points during the 2-hour main session. Numerical results for that outcome and the analysis methods are not reported in the registry record. Safety information lists zero serious adverse events and zero deaths in each group, along with other adverse-event counts.

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