Extending taVNS Paired With Infant CIMT Into a Home-Based Setting: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Extending taVNS Paired With Infant CIMT Into a Home-Based Setting (NCT05857527), a non-randomized early/phase 1 study. The primary outcome is Device Feasibility.

2. Clinical Question

The central question is whether the EMG-triggered stimulation system can be implemented during infant CIMT, including in a home setting. The registry describes the work as technology development requisite for a randomized trial. That framing matters: the primary endpoint is device feasibility, rather than a comparison of clinical benefit between assigned treatments.

The record describes the target population as infants aged 6-18 months with one-sided weakness and identifies cerebral palsy as the condition. It also explains the clinical rationale: weakness on one side can affect reaching and grasping, and CIMT encourages use of the weaker side by restraining the stronger arm. The study pairs CIMT with non-invasive taVNS, with stimulation prompted by detected muscle activity.

Because allocation is non-randomized and the study is sequential, the record does not establish a controlled estimate of the effect of taVNS, CIMT, or their combination. The primary question is whether the system can trigger stimulation during treatment. Although the study description mentions safety and effectiveness, a primary feasibility result and clinical outcome results are not reported in the registry record.

3. Trial Design

This is a completed, early phase 1, non-randomized, unmasked, sequential study sponsored by the Medical University of South Carolina. The registry lists enrollment of 4 participants. The study started on 2023-04-17 and had a primary completion date of 2024-03-30.

The two intervention descriptions concern custom EMG-triggered Soterix taVNS paired with CIMT: one in the laboratory and one in the home. The arm descriptions specify a first phase trialing a taVNS unit with automated EMG sensors and an optional Bluetooth manual trigger during CIMT rehabilitation, followed by a second phase trialing the EMG-triggered system for taVNS and CIMT in the home setting. This sequential structure is not a randomized comparison, and the two settings should not be treated as equivalent control and intervention arms.

The primary endpoint is Device Feasibility, measured as the percent of total treatment time during which EMG can successfully trigger stimulation in a CIMT rehabilitation session. It is defined as a mean with full-range dispersion and is assessed at the end of a 4 week treatment intervention described as 40 hours of CIMT. The registry lists the Fidelity of Implementation Measure (FIRM) and the Quality of Upper Extremity Skills Test (QUEST) as secondary outcomes. Three outcome measures are listed in total, but the registry record does not report their results.

The record lists no statistical analyses. It does not report a sample-size justification, a detailed statistical analysis plan, an interim analysis plan, or a masking procedure beyond stating that masking is none. The stated enrollment is small, and the lack of randomization means that this design is best read as an initial feasibility and technology-development study rather than as a controlled test of comparative effectiveness.

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: All participants received 40 hours of CIMT paired with taVNS. The first 2 participants received treatment in the lab so the engineer could address sensor calibration and settings to automate EMG triggering. The remaining participants received the same 40 hours of CIMT paired with taVNS in the home setting with the goal to test feasibility of translation of the new EMG triggered taVNS into standard home therapy settings. Participants were told if they would be in home or lab before consent.

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.

6. Primary Endpoint

The registry lists the primary outcome as Device Feasibility, measured over end of 4 week treatment intervention (40 hours of CIMT).

The primary endpoint is Device Feasibility: the mean percent of total treatment time during which EMG can successfully trigger taVNS while CIMT is taking place. The registry defines the measure over a treatment intervention lasting 4 weeks and described as 40 hours of CIMT, with assessment at the end of that intervention. Dispersion is specified as the full range.

This endpoint addresses a practical step in pairing stimulation with active movement. An EMG sensor must detect muscle activity, and the system must trigger stimulation in the treatment setting. If those steps cannot be carried out reliably, the intended pairing of stimulation and movement may not be implemented as planned. In that sense, a measure of the share of treatment time with successful triggering is relevant to device feasibility.

That measurement is not itself a measure of motor improvement, developmental progress, or treatment benefit. Nor does a mean alone describe how individual participants’ experiences vary; the registry’s stated full-range dispersion is intended to describe the observed span. The record does not report the mean, the range, or the underlying participant-level observations, so the level of feasibility observed cannot be assessed from the registry record.

As general statistical context, a mean gives an average across observations, while a range describes the lowest and highest observations included. In a small feasibility study, both can be sensitive to individual observations. Their interpretation also depends on how time with successful triggering was recorded and how missing or interrupted treatment time was handled; those details are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Several design and measurement concepts help frame what this study can answer. The registry calls the study early phase 1, non-randomized, unmasked, and sequential. These terms describe different aspects of a trial. Phase characterizes the development stage; allocation describes how participants are assigned; masking concerns whether treatment assignment is concealed from participants or study personnel; and the model describes the order or structure of the study phases. Here, the record reports no masking and no random allocation.

What does a sequential design imply?

In a sequential design, the study proceeds through phases rather than using randomized, concurrent groups as the basis for comparison. The arm descriptions place a laboratory feasibility trial before a home-setting trial. This allows the study to examine the system in more than one setting, but it does not isolate the effect of setting. General statistical reasoning: when groups or phases are not randomized and concurrent, differences may be associated with the setting, the sequence, or other differences in implementation. A direct causal comparison requires design and analysis features that address those alternatives; those features are not reported in the registry record.

What does the primary measure capture?

The endpoint is a mean percent of total treatment time during which EMG successfully triggers stimulation during CIMT. It is a process measure: it describes whether the device performs its intended triggering function during treatment. It is distinct from a patient-centered outcome such as a change in motor skills. General statistical reasoning: a mean compresses multiple observations into an average, while a full range describes the observed extremes. The range does not, on its own, show how observations are distributed between those extremes, and the mean does not show how much participants differ from one another.

The registry specifies the assessment at the end of a 4 week intervention described as 40 hours of CIMT. It does not report how many sessions contributed to the measure, whether time was recorded continuously or in segments, or what counted as a successful trigger. It also does not state how interruptions, missing sensor data, or sessions with incomplete treatment time were handled. These details matter because they define the numerator and denominator of a time-based percentage and can affect reproducibility.

What can be inferred from a small feasibility study?

Enrollment is listed as 4. General statistical reasoning: with a small group, a single participant’s observations can have a substantial influence on a mean and on the endpoints of a range. Small feasibility studies can identify practical implementation issues and support refinement of procedures, but estimates are generally imprecise and may not represent performance in other participants or settings. The registry record does not report an uncertainty interval for the endpoint or a statistical analysis that would quantify its precision.

The record lists 0 analyses. It gives the primary outcome’s mean and full-range measurement specification, but no observed result. No p-value, confidence interval, model estimate, or participant-level data are reported in the registry record. General statistical context: a confidence interval is a range of values compatible with an estimate under stated assumptions; it helps communicate precision. A p-value summarizes how unusual data would be under a particular null model and test, but does not measure the size or practical importance of an effect. Neither type of result can be interpreted without knowing the analysis and the data to which it applies.

Why does randomization matter for comparisons?

Random assignment is a design method intended to make comparison groups similar on average in both measured and unmeasured factors. This study is explicitly non-randomized, and the registry notes that its arms are not a like-for-like control comparison. Therefore, the two intervention settings should be read as successive feasibility activities, not as evidence that one setting performs better than the other. The record does not describe a separate untreated or alternative-treatment control group.

General statistical reasoning: adjustment for measured characteristics can sometimes address observed group differences, but it cannot guarantee balance on unmeasured factors. In this record, no analysis is listed, so there is no basis for describing an adjusted comparison. The sequential structure and absence of random allocation should remain central when interpreting any future results from these phases.

How should planning calculations be read?

General statistical context: sample-size calculations are planning exercises based on assumptions about the effect to detect, statistical significance level, allocation, and analysis method. A planning illustration is not an observed result, and it is not observed power. The registry record states that planning illustrations use a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. It also distinguishes total events for time-to-event calculations from participants per arm for other calculations. These are planning assumptions, not evidence that the present study used a randomized two-arm design or that it was designed around those calculations. The record does not report the study’s own sample-size justification.

The phrase over-dispersion refers generally to variability greater than a statistical model expects. When present, it can make standard errors and confidence intervals too small if the model does not account for it. The registry record does not report a count model, a dispersion analysis, or an analysis plan for this endpoint, so over-dispersion is not a reported feature of this study. It should not be assumed merely because the outcome is expressed as a percentage.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists three outcome measures: Device Feasibility as the primary outcome, plus FIRM and QUEST as secondary outcomes. It does not report results for these outcomes or any statistical analyses. The record also does not describe a prespecified hierarchy of tests, a multiplicity adjustment, or a plan for choosing among multiple outcomes. Those elements are not reported in the registry record, so it is not possible to determine how the study would control the chance of false-positive findings if several outcomes were tested.

General statistical context: when many outcomes or hypotheses are tested, the chance of at least one apparently unusual result can increase. A prespecified analysis plan can clarify which outcome is primary and how secondary outcomes will be interpreted. This general concern should not be mistaken for evidence that the study conducted multiple statistical tests; the registry lists 0 analyses.

Missing-data handling is not reported in the registry record. The record does not say whether all enrolled participants completed treatment, whether all endpoint observations were available, how incomplete treatment sessions were handled, or whether missing values were excluded or otherwise addressed. Analysis populations are also not reported: there is no description of an intention-to-treat, per-protocol, or other analysis set. Those labels should not be inferred from the intervention descriptions or from the enrollment count.

For a time-based feasibility endpoint, missing sensor readings or incomplete sessions could affect how the percentage is defined. General statistical reasoning: excluding incomplete observations can change the population represented by the result, while assumptions used to handle missing values can influence estimates. Because neither the missingness pattern nor its treatment is reported, the potential effect on any endpoint estimate cannot be evaluated. The registry record does not give enough information to determine whether any data were missing.

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 registry lists the group “Soterix taVNS Stimulation Using EMG Sensors” with 4 participants at risk for serious adverse events and 0 affected. It also lists 4 at risk for other adverse events and 0 affected, with 0 deaths. No top serious adverse-event terms are listed.

These counts describe the adverse-event entries in the registry record. They do not establish that every possible event was assessed in the same way, and they do not quantify the risk of uncommon events with precision. In general, a count of zero in a small group does not show that the underlying risk is zero; it means that no event in the relevant category is recorded for the participants listed as at risk.

The record does not report event definitions, severity grading details, surveillance procedures, duration of exposure, or participant-level safety observations. It also does not provide a comparison group for interpreting the counts relative to another treatment or setting. The safety entries should therefore be read as descriptive registry counts, not as a comparative safety estimate.

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

This study addresses an implementation question: can EMG sensors trigger taVNS during CIMT, including when treatment is delivered in the home? The registry describes a laboratory phase followed by a home phase and identifies the primary measure as the mean percent of treatment time with successful triggering. That focus fits the record’s description of technology development in preparation for a randomized trial.

The record does not report the observed primary endpoint, the secondary outcome results, or statistical analyses. It therefore does not show how much treatment time involved successful triggering, how much participant-to-participant variation occurred, or whether upper-extremity skills changed. The registry’s completed status does not substitute for those results.

The study also cannot establish comparative benefit from its design as described. It is non-randomized and sequential, with no like-for-like control comparison. The laboratory and home phases cannot be interpreted as a randomized test of setting, and the combined intervention does not separate the contribution of CIMT from the contribution of taVNS. No treatment-effect estimate or uncertainty interval is reported.

As general statistical context, feasibility findings and effectiveness findings answer different questions. Feasibility asks whether a procedure or device can be implemented; effectiveness asks whether an intervention improves a defined outcome relative to an appropriate comparison. A favorable feasibility result, if reported, would not by itself establish clinical benefit. Conversely, the absence of an outcome value in the registry record is not evidence that the system failed or that treatment had no effect.

The appropriate conclusion from the available record is limited: it documents a small, sequential technology-development study, its intended device-feasibility endpoint, and registry-reported adverse-event counts. It does not provide enough outcome or analysis information to judge the observed device performance, changes in motor skills, or comparative effects.

13. Why This Trial Matters Statistically

Feasibility is a consequential statistical question when a treatment depends on reliable coordination between a device and a participant’s movement. In this study, EMG sensors are intended to detect muscle activity and trigger taVNS during CIMT. Measuring the proportion of treatment time with successful triggering focuses attention on whether that operational link can be carried out during rehabilitation, rather than assuming that a device can be implemented simply because it has been developed.

The home setting adds a distinct implementation context. A system used in a laboratory and one used at home may encounter different practical conditions. The sequential design allows the registry to describe work in both settings, but does not provide a randomized comparison between them. Recognizing that distinction is statistically important: the order of phases and the setting are not separated by random allocation in this record.

The study is also framed as technology development requisite for a randomized trial. A feasibility study can inform whether procedures are workable and what further evaluation might require. That role differs from estimating a treatment effect with a controlled design. It is useful to keep those goals distinct so that a process measure is not interpreted as proof of clinical improvement.

The record’s small enrollment and missing outcome results also illustrate why transparent reporting matters. A numerical endpoint and its variability would allow readers to judge observed performance and precision; analysis details would clarify which observations contributed and how incomplete data were handled. Without them, the record supports understanding of the research question and design, but not a statistical conclusion about device performance or clinical outcomes.

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 principal limitation is that the registry record does not report the primary feasibility value, the full range, or the secondary outcome results. It also lists 0 analyses. As a result, the study’s observed device performance and any changes in upper-extremity skills cannot be assessed from the record.

Enrollment is 4, limiting the amount of information available for estimating averages, variability, and safety outcomes. The study is non-randomized, unmasked, and sequential. It does not provide a like-for-like control comparison, and the laboratory and home phases cannot be interpreted as randomized alternatives. The design also does not separate the effects of CIMT and taVNS.

The registry record does not report the sample-size justification, a detailed analysis plan, how missing data were handled, or which analysis populations were used. It does not describe how successful triggering was operationally defined beyond the stated endpoint description, or how interruptions and incomplete treatment time were handled. These gaps limit reproducibility and interpretation of the percentage measure.

The safety counts are descriptive and come from a small group; they cannot precisely establish the frequency of uncommon events. The record does not provide detailed event definitions or monitoring procedures. Finally, although the study is listed as completed, completion status alone does not supply outcome data or resolve these design and reporting limitations.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Extending taVNS Paired With Infant CIMT Into a Home-Based Setting — NCT05857527.
• Registry record last updated 2025-07-04; status last verified 2025-07.
• Results first posted 2025-07-04.
• 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 describes a completed early phase 1 study of custom EMG-triggered taVNS paired with CIMT, conducted sequentially in laboratory and home settings. It is non-randomized and unmasked, with enrollment of 4 participants. The sponsor is the Medical University of South Carolina.

The primary outcome is Device Feasibility, defined as the mean percent of total CIMT treatment time during which EMG successfully triggers stimulation, assessed at the end of a 4 week intervention described as 40 hours of CIMT. FIRM and QUEST are listed as secondary outcomes. The registry does not report outcome values or statistical analyses.

For the listed stimulation group, 0 serious adverse events and 0 other adverse events are recorded among 4 participants at risk, with 0 deaths. The study’s design and reported counts can be described, but the registry record does not establish device performance, clinical improvement, or comparative treatment effects.