Neural Facilitation of Movements in People With SCI: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Neural Facilitation of Movements in People With SCI (NCT05354206), a non-randomized na study. The primary outcome is Changes in Corticospinal Tract Excitability After Training.

2. Clinical Question

The study’s stated purpose was to understand the contribution of individual neural tracts to movements facilitated by transcutaneous spinal cord stimulation. In particular, the assessments were intended to evaluate corticospinal and reticulospinal tract excitability in relation to stimulation-assisted leg movements. The record also lists reaction-time evaluation and training with some stimulation, but does not report a completed primary outcome result. Accordingly, the clinical question remains a research question in this record: it does not contain an observed estimate of change in corticospinal excitability. The registry record does not report a treatment-effect comparison, a control condition, or evidence that would establish whether the assessment procedures changed movement or neural activity.

3. Trial Design

This was a non-randomized, parallel-arm study listed as terminated. The registry record reports an enrollment of 20. Because allocation was not randomized, assignment to the described arms should not be interpreted as if it created comparable groups by chance. The record explicitly cautions that the arms are not a like-for-like control comparison. It does not report how participants were assigned or whether any characteristics were considered when assigning them.

The two arm descriptions differ in the order of neural assessments. In the motor evoked potential evaluation arm, transcranial magnetic stimulation was used first to evaluate corticospinal tract excitability, followed by loud auditory stimuli to evaluate reticulospinal tract excitability. In the reaction-time evaluation arm, loud auditory stimuli were used first, followed by transcranial magnetic stimulation. The record also lists electrophysiology assessments of the corticospinal and reticulospinal tracts and training with some stimulation. Detailed procedures, treatment schedules, and the relationship between the listed intervention and each arm are not reported in the registry record.

Masking is listed as none. The study is classified as phase NA, which does not provide a phase designation. The registry reports a start date of 2022-06-23 and a primary completion date of 2023-03-06; its status is terminated. It states that primary outcome data were not collected because of early termination. The reason for termination and whether any secondary outcome data were collected are not reported in the registry record. Although the record lists an enrollment figure, it does not describe the number completing each assessment or provide a participant flow account.

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: Recruitment was only perform for the second arm of the study: evaluating reticulospinal tract contributions during different types of movements. Participants performed range-of-motion and precision-control tasks in randomized order during the same session. As this study was terminated early based on change in funding, no participants were assigned to the "Evaluation of Motor Evoked Potentials" arm, and no data could be provided for this outcome measure.

Overall Study

Reasons for not completing this period:

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: This study was terminated early due to change in fundion. Therefore, no participants were enrolled for the evaluation of motor evoked potentials, and no data can be reported.

6. Primary Endpoint

The registry lists the primary outcome as Changes in Corticospinal Tract Excitability After Training, measured over 30 minutes before and 30 minutes into intervention.

The primary endpoint was change in corticospinal tract excitability after training. Excitability was quantified by changes in the amplitude size of motor evoked potentials. The listed timeframe compares measurement 30 minutes before with measurement 30 minutes into the intervention. Thus, the intended endpoint was a change in a physiological measurement over the intervention period, rather than a direct measure of long-term functional recovery.

In general, motor evoked potentials are used as an electrophysiological indicator of responses elicited through motor pathways. Their amplitude can serve as a measurable signal for studying corticospinal excitability. A change in amplitude can be relevant to a mechanistic question about neural responses, but interpretation depends on how the measurements were collected, the analysis definition, and the variability of the signal. Those details are not reported in the registry record.

The endpoint description does not include a unit, parameter specification, or dispersion measure. Most importantly, the record says that data for this arm were not collected due to early study termination. It therefore contains no observed endpoint value or change estimate to interpret. The purpose of the endpoint is described, but the posted registry information cannot establish the size, direction, or precision of any change in corticospinal excitability.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The statistical information in a trial record needs to be read alongside the design and the availability of outcome data. In this study, the main constraint is that the primary endpoint data were not collected after early termination. The record does not report a primary estimate, a confidence interval, or a significance test for the planned endpoint. Statistical methods can clarify what such quantities would mean in general, but they cannot supply an unobserved result.

What would an endpoint estimate represent?

In general, an endpoint estimate is a numerical description of the outcome defined by the protocol or analysis. Here the primary outcome was intended to describe changes in motor evoked potential amplitude as a measure of corticospinal tract excitability. For a change endpoint, an estimate would represent the analyzed change according to the specified measurement and comparison procedure. The registry record does not report the detailed change calculation or a numerical estimate. As no data were collected for the primary outcome, there is no value to interpret as an observed change.

A confidence interval is, in general, a range of values compatible with the observed data under a particular statistical method and its assumptions. It communicates precision as well as the estimate’s uncertainty. A narrow interval generally indicates greater precision than a wide interval, while neither width nor location alone resolves design limitations or establishes causality. No primary endpoint confidence interval is reported in the registry record. Since the relevant outcome data were not collected, precision about the primary endpoint cannot be assessed from this record.

What would a statistical test answer?

In general, a statistical test evaluates how compatible observed data are with a specified null hypothesis, under the assumptions of the test. A p-value does not measure the probability that a hypothesis is true, nor does it describe the size or practical importance of an effect. Interpretation also depends on the analysis population, outcome definition, model, and study design. The registry record does not report a primary-outcome test statistic or p-value. It therefore provides no basis for claiming a statistically significant or non-significant primary result.

The record’s sample-size assumptions describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is the stated fraction of the observed effect. These are planning assumptions, not evidence that the study was designed or completed with those properties. The numerical planning illustrations are not included in the registry record for this explanation, so no sample-size values can be stated. In general, sample-size planning depends on assumptions about the effect to detect, variability, error rates, allocation, and analysis. The trial’s own sample-size justification is not reported in the registry record. Such planning values must not be described as observed power or as proof that a study could detect a particular effect.

Why does allocation matter?

In general, random allocation is intended to reduce systematic differences between groups at baseline, on average. This study is listed as non-randomized, and the registry specifically warns that its arms are not a like-for-like control comparison. An arm contrast would therefore require cautious interpretation, even if outcome estimates were available. Differences between arms could reflect factors other than the assessment sequence or intervention. The record does not report an adjustment strategy or a covariate model that would address such differences.

The parallel design means the arms are described as separate groups rather than sequential periods of a crossover comparison. The arm descriptions also place the electrophysiological assessments in different orders. In general, order can matter when measurement conditions, fatigue, adaptation, or carryover influence later assessments. These are possible methodological considerations, not reported effects in this study. The registry record does not report whether order effects, carryover, or within-person dependence were modeled.

What does missing outcome data imply?

Here, the record does not merely describe an incomplete value that could be handled by an imputation method: it states that data for the primary endpoint arm were not collected due to early study termination. In general, methods such as imputation require observed information and assumptions about why measurements are missing. They cannot recreate an outcome that was never collected without introducing assumptions that the data cannot verify. The record does not report a missing-data plan, analysis population, or approach to incomplete observations. No method should be presumed.

For these reasons, statistical interpretation is limited not only by the non-randomized design but by the absence of primary endpoint measurements. The statistical methods section of the registry record does not report enough detail to identify a fitted model or reproduce an endpoint analysis. General statistical concepts explain how an analysis could be interpreted if data and methods were available; they do not convert the study’s stated aims into results.

10. Multiplicity, Missing Data and Analysis Populations

The record identifies a primary outcome and states that the study included two outcome measures, but details of the other outcome and the analysis strategy are not reported in the registry record. The registry also lists one analysis without describing its model, hypotheses, or relationship to the outcomes. It does not report a hierarchy of outcomes, a multiplicity adjustment, or a plan for controlling the chance of false-positive findings across multiple tests.

In general, multiplicity arises when several outcomes, time points, comparisons, or statistical tests are considered. Conducting many tests can increase the chance that at least one appears unusual by chance. A prespecified testing hierarchy or adjustment may address that issue, depending on the scientific question and analysis plan. The record does not provide information to determine whether such procedures were planned or used. Because primary outcome data were not collected, the main endpoint cannot be assessed regardless of any multiplicity approach.

The registry record does not report an analysis population, participant flow, or a missing-data method. It states that primary outcome data were not collected for the arm due to early study termination. This is distinct from a reported analysis in which some collected measurements are missing. In general, missing-data methods rely on assumptions about observed and unobserved information; without the relevant endpoint measurements and a documented plan, the adequacy of any approach cannot be evaluated. The reason for termination and whether other outcomes had collected data are not reported in the registry record.

No interim-analysis plan or stopping rule is reported in the registry record. The fact that the study was terminated does not establish why it stopped or whether a statistical boundary was involved. The record does not report an intention-to-treat or per-protocol analysis, nor does it identify exclusions from an analysis set. Therefore, neither multiplicity control nor the handling of missing observations can be independently assessed from the information recorded.

11. 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.

The serious adverse event figures should be interpreted together with the listed at-risk counts. For the reaction-time evaluation arm, the registry reports 20 at risk for serious adverse events and 0 serious adverse events; it also reports 20 at risk for other adverse events and 0 other adverse events. Deaths are reported as 0. For the motor evoked potential evaluation arm, the at-risk counts are 0 for serious and other adverse events, with 0 events and 0 deaths reported.

The zero at-risk counts in the motor evoked potential evaluation arm matter: its zero event entries do not represent safety observations among participants listed as at risk in that arm. They should not be read as evidence that the arm was observed and had no events. The registry record does not explain why the at-risk count is zero or provide further safety follow-up details.

In general, an adverse event count describes events recorded under a study’s reporting definitions and observation period. A zero count does not establish that an intervention is free of risk, particularly when exposure and follow-up are limited or unclear. The registry does not report event timing, severity beyond the serious-versus-other categories, causal attribution, or detailed surveillance methods. The entries describe what was recorded, not a comparative safety estimate. Because the arms were non-randomized and not a like-for-like control comparison, the figures should not be used to infer a relative safety difference.

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

The record establishes that the study was designed to investigate neural tract contributions to movements facilitated by transcutaneous spinal cord stimulation in people with spinal cord injury. It specifies a primary physiological outcome: change in corticospinal tract excitability, assessed by motor evoked potential amplitude. It also describes assessments intended to examine corticospinal and reticulospinal excitability, with different orders in the two arms.

What the record does not establish is the size or direction of a primary outcome change. The registry explicitly states that the primary data for the arm were not collected because of early termination. There is consequently no endpoint estimate to interpret, and no reported uncertainty interval or statistical test to indicate precision or compatibility with a null hypothesis. The record does not show that excitability increased, decreased, or remained unchanged.

In general, mechanistic measurements can help researchers investigate physiological pathways, but a change in a laboratory measure is not by itself equivalent to a change in functional ability or long-term recovery. The primary outcome described is a neural excitability measure, not a reported functional recovery endpoint. The record does not provide a result linking motor evoked potential amplitude to movement or to lasting neurological change.

The study’s non-randomized allocation and lack of masking also constrain the interpretation of any potential comparison. Its arms differ in assessment order, and the registry cautions that they are not a like-for-like control comparison. These design details should not be treated as evidence that one arm was superior or that a difference was caused by a particular stimulation procedure.

Overall, the posted information documents a research aim, planned measurements, design features, termination status, and limited safety counts. It does not provide evidence from the primary endpoint that can support a claim about an effect of stimulation or training. The findings should therefore be described as unavailable in the registry record, rather than as a positive, negative, or null result.

13. Why This Trial Matters Statistically

This study is statistically informative in part because it shows the difference between a registered research question and an analyzable result. The record describes a mechanistic question about neural pathways and stimulation-assisted movement, and it names a physiological outcome intended to quantify corticospinal excitability. But because the primary outcome data were not collected, the planned measurement cannot be converted into an estimate, an uncertainty interval, or a statistical test result.

That distinction matters in clinical research. A stated objective does not establish an effect, and an absent measurement is not a measured absence of effect. When a trial terminates before its primary outcome is collected, readers cannot assess the magnitude or precision of that outcome. This record makes the data-availability limitation explicit, which helps prevent the study aim from being mistaken for an outcome finding.

The design also illustrates why a comparison’s structure matters. Non-randomized allocation can leave groups different for reasons other than the procedures under study. The registry further says that these arms are not a like-for-like control comparison. Their assessment sequences differ, so any future arm-level contrast would need a clear account of assignment and analysis to support interpretation. Those issues are separate from whether the physiological measure itself is useful.

Finally, the record makes clear that safety counts need denominators and context. The reaction-time arm has listed participants at risk and no recorded events, whereas the other arm has zero listed at risk. Reporting both the event count and the at-risk count prevents the same apparent zero from being treated as equivalent evidence across arms. Statistically, the important lesson is not a treatment conclusion but the need to distinguish measurement plans, observed data, and the limits of comparisons.

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 primary limitation is that the registry states that the primary outcome data were not collected due to early study termination. Without those data, there is no observed estimate of change in motor evoked potential amplitude, and the primary research question cannot be answered from the posted record. The reason for termination is not reported in the registry record.

The design was non-randomized, and the registry warns that the arms are not a like-for-like control comparison. Masking is listed as none. The two arm descriptions also specify different orders for the auditory and transcranial magnetic stimulation assessments. These features limit causal and comparative interpretation. The record does not report assignment procedures, baseline characteristics, or whether analysis adjusted for any group differences.

The record reports enrollment of 20 but does not provide participant flow, completion counts by assessment, or an account of which outcomes have collected data. Detailed eligibility criteria, stimulation parameters, training procedures, and measurement protocols are not reported in the registry record. The analysis model, statistical plan, sample-size justification, and missing-data approach are also not reported in the registry record. The planning assumptions described for sample-size illustrations are not a substitute for a reported trial design justification.

Safety interpretation is limited by the different at-risk counts, including a zero at-risk count in one arm. The registry does not report detailed adverse-event definitions, timing, follow-up, or causal assessments. More generally, the record does not provide enough information to evaluate how the planned analyses would handle multiple outcomes, order effects, or incomplete data. These limitations prevent a fuller assessment of either the study’s intended comparison or the extent of its safety observations.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Neural Facilitation of Movements in People With SCI — NCT05354206.
• Registry record last updated 2024-11-22; status last verified 2024-10.
• Results first posted 2024-11-22.
• 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.

18. Record Summary

The registry record describes a terminated, non-randomized, parallel study of neural facilitation of movement in people with spinal cord injury. It lists enrollment of 20, no masking, and a primary outcome of change in corticospinal tract excitability measured through motor evoked potential amplitude. The intended timeframe was 30 minutes before and 30 minutes into the intervention.

The study aimed to examine contributions of corticospinal and reticulospinal tracts to movements facilitated by transcutaneous spinal cord stimulation. Its two arm descriptions use different orders of transcranial magnetic stimulation and loud auditory stimuli. The registry cautions that the arms are not a like-for-like control comparison.

The primary outcome data were not collected because of early study termination. Thus, the record contains no reported primary estimate or precision measure. Safety entries report zero events in the reaction-time arm, with 20 at risk, while the other arm lists zero at risk. The reason for termination and further analysis details are not reported in the registry record.