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 Pediatric Teleneuromodulation (NCT05071586), a na na study. The primary outcome is Status/Safety Assessment.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05071586 |
| Phase | NA |
| Condition | Cerebral Palsy (CP) |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 10 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Wisconsin, Madison |
| Results posted | Yes |
2. Clinical Question
Population
Children aged 8 to 21 with hemiparetic cerebral palsy and a history of perinatal stroke or brain bleed were the intended population. The record also describes eligible participants as male and female US residents with an established diagnosis of stroke or brain bleed. The enrollment was 10.
Intervention
Participants received active, non-invasive brain stimulation using the Soterix 1x1 tDCS LTE Stimulator Device Model 1401. The study involved remote monitoring, synchronous safety monitoring, and guided instruction with laboratory staff after appropriate training.
Comparator
There was no control group or randomized comparison. The study is registered as a single-group study, so its results describe the enrolled group rather than a contrast between stimulation and another treatment or usual care.
Primary question
The primary outcome is a count of sessions in which a symptom was reported on an adverse event survey during active stimulation. The registry record does not report the observed primary outcome value. The record does report adverse-event summary figures, including no serious adverse events and other adverse events affecting 10 participants. Those safety figures do not substitute for the missing primary outcome result.
3. Trial Design
The study, titled Pediatric Teleneuromodulation, is registered as NCT05071586. Its official title is Remotely Monitored Transcranial Direct Current Stimulation in Children With Cerebral Palsy. The sponsor is the University of Wisconsin, Madison. The record lists the study as completed, with a start date of 2022-12-21 and a primary completion date of 2023-06-06.
This is a single-group study with enrollment of 10. Allocation and phase are listed as not applicable, and masking is listed as none. Those details mean the registry record does not describe random assignment, masking, or a parallel comparison group. Consequently, the design can describe what was observed in the enrolled participants, but cannot by itself separate changes or events associated with study participation from those that might have occurred without the intervention.
The intervention was the Soterix 1x1 tDCS LTE Stimulator Device Model 1401, classified as a device. The study summary describes active stimulation with remote and synchronous safety monitoring and guided instruction from laboratory staff following appropriate training. The intended study period was 5 days. The primary safety assessment covered active stimulation sessions of 20 min over 3 days total.
The record names Average Setup Time for Each Session and Change in Box and Blocks Assessment Score among the secondary outcomes. It lists six outcome measures in total. The registry record does not report a statistical analysis plan, the method used to analyze the primary outcome, or an analysis population. It lists no analyses. The recorded completion status is not, on its own, evidence that every planned measure has a posted result.
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 | Children Diagnosed With Stroke/Brain Bleed |
|---|---|
| STARTED | 10 |
| COMPLETED | 10 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Male and females aged 8 to 21 with established diagnosis of stroke/brain bleed who are US residents.
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 | Children Diagnosed With Stroke/Brain Bleed |
|---|---|---|
| Participants analysed | 10 | |
| Age, Customized: 10 years old | Participants | 1 |
| Age, Customized: 13 years old | Participants | 2 |
| Age, Customized: 15 years old | Participants | 1 |
| Age, Customized: 16 years old | Participants | 4 |
| Age, Customized: 18 years old | Participants | 1 |
| Age, Customized: 19 years old | Participants | 1 |
| Sex: Female, Male: Female | Participants | 4 |
| Sex: Female, Male: Male | Participants | 6 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 9 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 1 |
| 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 | 8 |
| Race (NIH/OMB): More than one race | Participants | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 10 |
6. Primary Endpoint
The registry lists the primary outcome as Status/Safety Assessment, measured over Active Stimulation Sessions (20 min), 3 days total.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | number of sessions symptom reported |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is titled Status/Safety Assessment and is expressed as the number of sessions with a symptom report. During active stimulation, participants were asked to complete an adverse event survey. The description says the reported responses include survey reports regardless of whether the event was considered potentially related to stimulation. This endpoint therefore concerns reported symptoms during the study sessions, not a determination that stimulation caused a symptom.
A session-based count can capture repeated reports across stimulation sessions. It is different from a count of participants who experienced an event: one participant could contribute reports at more than one session, while a participant-level summary would ordinarily count people rather than sessions. The registry record does not give the observed primary endpoint value, a breakdown by symptom, or a rule for handling repeated reports. It is therefore not possible to describe the frequency or pattern of session-level symptom reports from the primary endpoint as registered.
In general, monitoring symptoms during active treatment is useful for characterizing the safety experience under the study conditions. The result would need context about how reports were collected, the number of evaluable sessions, and how symptoms were classified to support a fuller interpretation. Those details, beyond the survey description and stated timeframe, are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record describes a feasibility and safety-focused study in children with cerebral palsy receiving remotely monitored active stimulation. Its single-group design is suited to documenting what happened among enrolled participants under the described procedures. It does not provide a randomized comparison that could estimate how outcomes differed from an untreated or alternatively treated group.
The primary measure is a count of sessions with reported symptoms. The registry record gives the outcome definition and assessment period, but does not report the primary result. As a result, no conclusion about the observed session-level symptom count or its precision can be drawn from the registered primary outcome information. The absence of a posted primary result should not be read as evidence that no symptoms occurred.
The adverse-event summary separately records 10 participants at risk for other adverse events and 10 affected, alongside 10 at risk for serious adverse events and zero affected. Deaths are recorded as zero. These are participant-level summary figures, not the primary endpoint's session-level count. The record does not give the terms for the other adverse events or list serious adverse-event terms. It also does not show whether the other events were considered related to stimulation; the primary survey description explicitly includes responses regardless of potential relation, but that statement should not be extended to other classifications.
Enrollment was 10, and the record presents no analysis results. This means there is no posted inferential estimate, confidence interval, or statistical test to assess for the primary endpoint. The study can still provide descriptive information, but a small single-group study has limited ability to characterize uncommon events, estimate variation reliably, or support comparisons across groups.
The record's completed status indicates a registry status, not that all outcomes have been reported or that the design answered every planned question. Results for the named secondary outcomes and other outcome measures are not reported in the registry record. The available figures should therefore be read as a limited account of the registry's adverse-event summary, rather than a complete statistical evaluation of the study.
9. Statistical Methods Explained
What does a single-group design estimate?
A single-group study records outcomes among participants receiving the intervention without a concurrent control group. Its descriptive estimates can characterize the participants' observed experience, but they do not isolate an intervention effect from other influences. Changes over time may reflect natural variation, measurement conditions, participation in the study, or other factors. A controlled comparison is generally needed to estimate differences between treatment strategies while accounting for such influences.
Here, the registered model is single group, allocation is not applicable, and masking is none. The record therefore supports a description of the enrolled group and the recorded safety outcomes, not a causal comparison. No randomized or like-for-like control comparison is registered.
How should a session count be understood?
The primary endpoint counts sessions with symptom reports. A count is not the same quantity as a proportion of participants reporting a symptom, nor is it necessarily a count of unique symptoms or unique events. Repeated reports from the same person may contribute more than once if the outcome is recorded by session. Interpreting such a count generally requires knowing how many sessions were completed and evaluable, whether all participants contributed the same number of sessions, and how duplicate or continuing symptoms were handled. Those details are not reported in the registry record.
In general, count data are often analyzed with methods suited to nonnegative event counts. A simple count model may assume that the variability follows a particular relationship to the average count. If the data are more variable than that assumption allows, over-dispersion can make standard errors too small and confidence intervals too narrow. Methods that account for extra variability may be considered in such settings. This is general statistical context, not a description of an analysis reported for this study: the registry record lists no analyses and does not identify a model for the primary endpoint.
What does a confidence interval contribute?
In general, a confidence interval describes the statistical uncertainty around an estimated quantity under the assumptions of the analysis. A narrow interval indicates greater precision under those assumptions; a wide interval indicates less precision. For a count outcome, the appropriate interval depends on the data structure and the model used. A confidence interval cannot correct for a missing control group, unmeasured confounding, incomplete outcome reporting, or an analysis model that does not fit the data. No confidence interval for the primary endpoint is reported in the registry record.
How should planning calculations be read?
Any sample-size calculation based on an observed effect is a planning illustration, not observed power. It describes hypothetical planning under stated assumptions; it does not measure the probability that this completed study detected an effect. The registry record's planning description refers to a hypothetical equal-allocation comparison and a normal approximation. Those assumptions do not describe the registered single-group design. The record does not report a trial-specific sample-size justification or a design calculation for the single-group study.
In general, planning estimates depend on the outcome definition, variability, target effect, significance level, allocation, and analysis method. When those assumptions do not match the actual study design or endpoint, a planning illustration should not be interpreted as evidence about the precision or success of the completed study. No actual planning estimate or effect fraction is stated in the registry record.
What can be inferred from the available analysis record?
The registry record lists six outcome measures and zero analyses. It does not report an analysis method, a statistical test, an estimate of effect, or a measure of uncertainty for the primary outcome. This limits statistical interpretation to the endpoint description and the posted adverse-event summary. General methods can explain what would be useful for analysis, but they cannot fill in results or decisions that are not recorded.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists six outcome measures, including the named secondary outcomes Average Setup Time for Each Session and Change in Box and Blocks Assessment Score. It lists zero analyses. The primary endpoint's observed result and results for the secondary outcomes are not reported in the registry record.
Multiplicity is the issue that arises when many outcomes or statistical tests are examined: the chance of at least one apparently notable result can increase as the number of tests grows. In general, a prespecified analysis plan may identify a primary outcome and specify whether or how to adjust for multiple comparisons. The registry record does not report such a plan, any multiplicity adjustment, or inferential analyses. No claim about how multiplicity was handled can therefore be made.
Missing-data handling is also not reported in the registry record. The record does not state how incomplete surveys, missed sessions, or unavailable outcome assessments were treated, nor does it provide outcome-specific denominators for the primary endpoint. Without those details, it is not possible to judge whether the posted summaries include all expected observations or whether missingness could affect their interpretation.
An analysis population, such as a defined set of participants included in each outcome analysis, is not reported in the registry record. The enrollment and adverse-event at-risk figures describe registry information, but do not establish the analysis population for every outcome. These omissions limit reproducibility and make it harder to compare the registered outcome definitions with any analyses that may have been conducted outside the registry record.
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 |
|---|---|---|---|
| Children Diagnosed With Stroke/Brain Bleed | 0 | 10 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Children Diagnosed With Stroke/Brain Bleed | 0 of 10 |
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 |
|---|---|
| Children Diagnosed With Stroke/Brain Bleed | 10 of 10 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Children Diagnosed With Stroke/Brain Bleed |
|---|---|---|
| Tingling | General disorders | 9 of 10 |
| Unusual feelings on skin of head | General disorders | 8 of 10 |
| Sleepiness | General disorders | 7 of 10 |
| Itching | General disorders | 6 of 10 |
| Difficulty paying attention | General disorders | 6 of 10 |
| Headache | General disorders | 4 of 10 |
| Anxiety | Psychiatric disorders | 2 of 10 |
| Tooth pain | General disorders | 1 of 10 |
| Dizziness | General disorders | 1 of 10 |
| Forgetfulness | Psychiatric disorders | 1 of 10 |
The adverse-event summary records 10 participants at risk for serious adverse events and zero affected. It records 10 participants at risk for other adverse events and 10 affected. Deaths are recorded as zero. These figures should be read as the registry's participant-level safety summary; they are distinct from the primary endpoint, which counts sessions with symptom reports.
The summary does not provide the terms or descriptions for the other adverse events, and no serious adverse-event terms are listed. It also does not establish from the information in the record whether an event was caused by stimulation. The primary survey description says responses were reported regardless of potential relation to stimulation, but that endpoint definition does not establish causality. The number of participants affected is not a count of event episodes, and the registry record does not report episode-level detail.
Zero serious adverse events in this study is a descriptive finding for the participants and observation recorded. It does not establish that serious events cannot occur. In general, the ability to identify uncommon risks depends on the amount and duration of observation and the quality and completeness of event reporting. The registry record does not provide enough detail to characterize those factors beyond the stated active-session timeframe.
12. What the Result Does, and Does Not, Mean
The registry record documents a completed single-group study of remotely monitored transcranial direct current stimulation in children with cerebral palsy. It describes the intervention, the intended population, a session-based symptom-report endpoint, and a participant-level adverse-event summary. The record also reports zero serious adverse events and zero deaths, while indicating that other adverse events affected 10 participants.
These findings describe the safety information recorded for this study; they do not establish that stimulation caused or prevented any event. Nor do they establish whether stimulation changes motor function or provides benefit. The registry record does not report the primary outcome value or results for the named secondary outcomes. With no control group, the study also cannot estimate an intervention-versus-control difference.
It is important to distinguish the different units of observation. The primary endpoint concerns sessions with symptom reports, whereas the adverse-event summary gives participants at risk and affected. The registry does not provide the primary session count, symptom-level detail, or the handling of repeated reports. Consequently, the available record cannot show how many sessions involved reports or whether reporting was concentrated in particular participants.
In general, a small descriptive study can contribute information about whether study procedures and monitoring were undertaken in the enrolled group. It has limited capacity to characterize rare events or establish a precise risk estimate. Its findings should be interpreted within its eligibility criteria, intervention procedures, and limited design, rather than generalized automatically to other populations or settings.
The record's completion status does not replace missing outcome results or an analysis plan. The appropriate conclusion is that the registry supplies a limited descriptive safety summary, while the primary endpoint result, secondary outcome results, and statistical analyses are not reported in the registry record.
13. Why This Trial Matters Statistically
This study is statistically informative because its primary endpoint and safety summary use different units. The primary outcome is a count of sessions with symptom reports, while the adverse-event summary describes participants affected. Keeping those quantities separate is essential: a participant-level total cannot be used to reconstruct a session-level count, and the session-level count would not by itself indicate how many participants contributed reports.
The single-group design also clarifies the limits of the evidence. It can describe observations during remotely monitored active stimulation, but it does not provide a controlled estimate of how outcomes compare with another condition. This distinction is especially important when a registry record includes safety observations: reporting events during treatment is not the same as showing that treatment caused them.
The study focuses on a population and delivery arrangement that combine pediatric cerebral palsy, active brain stimulation, remote monitoring, and staff-guided instruction. Statistical interpretation must attend to the actual measurement and monitoring conditions rather than treating every safety count as interchangeable. For repeated session data, information about the number of evaluable sessions and dependence among observations would ordinarily help determine the precision of a count estimate. Such information is not reported in the registry record.
The record also illustrates why completion status and outcome reporting are separate issues. Although the study is marked completed, the primary outcome value and analyses are not reported. Clear registration and complete outcome reporting are both important for assessing what was measured, what was observed, and how uncertain the findings are. Without those results, readers can describe the registered question and safety summary, but cannot evaluate the primary endpoint's magnitude or precision.
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 main trial-specific limitation is the absence of the observed primary endpoint result in the registry record. The endpoint is defined as a number of sessions with reported symptoms, but no value or symptom breakdown is given. The adverse-event summary cannot stand in for that result because it uses participant-level figures and a separate classification.
The enrollment was 10, and the design was single group with no control comparison. That design limits causal interpretation and does not permit an intervention-versus-control estimate. The record does not report confidence intervals, statistical tests, or an analysis method. It also does not report results for the named secondary outcomes, despite listing six outcome measures overall.
Details needed to understand data completeness are not reported in the registry record. These include the number of completed or evaluable sessions, the handling of missing surveys, and the analysis population for each outcome. The record also does not give event descriptions for the other adverse events or explain how event relatedness was assessed. These gaps limit the interpretation of the safety summary.
The eligibility description is specific to children aged 8 to 21 with cerebral palsy and a history of stroke or brain bleed, with US residency also specified in the arm description. Findings from this study, even if fully reported, would not automatically apply to people outside that described population or to different monitoring and stimulation procedures. The study summary says participants could expect to be in the study for 5 days; it does not report each participant's actual observation period.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Pediatric Teleneuromodulation — NCT05071586.
- Registry record last updated 2024-05-07; status last verified 2024-04.
- Results first posted 2024-05-07.
- 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
NCT05071586, Pediatric Teleneuromodulation, is registered as a completed single-group study sponsored by the University of Wisconsin, Madison. It enrolled 10 and studied remotely monitored active transcranial direct current stimulation in children with cerebral palsy. The record lists no control comparison and no masking.
The primary endpoint is the number of sessions with symptom reports during active stimulation sessions of 20 min over 3 days total. Its observed result is not reported in the registry record. The adverse-event summary records zero participants affected by serious adverse events, 10 affected by other adverse events, and zero deaths. The record lists six outcome measures and zero analyses; results for the named secondary outcomes are not reported.