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 Transcutaneous Electrical Stimulation for Spasticity in Patients With Primary Lateral Sclerosis (NCT06012110), a na na study. The primary outcome is Modified Ashworth Scale.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06012110 |
| Phase | NA |
| Condition | Primary Lateral Sclerosis |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 6 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Nova Southeastern University |
| Results posted | Yes |
2. Clinical Question
Population
People with primary lateral sclerosis (PLS), a progressive upper motor neuron neurodegenerative disorder. The registry describes lower-extremity stiffness and spasticity, as well as bulbar involvement, as features of PLS. Enrollment is listed as 6. Further eligibility criteria and participant characteristics are not reported in the registry record.
Intervention
A single 30-minute session of transcutaneous electrical stimulation, with electrode pads placed on the back and abdomen. The registry describes participants lying supine while the current is adjusted to produce small muscle contractions in the legs, followed by the stimulation session.
Comparator
There is no concurrent comparison group in the recorded design. It is listed as a single-group study with allocation recorded as NA and masking as none. The primary outcome is assessed at baseline and immediately after the intervention, so the comparison is within the same group over time rather than against a control condition.
Primary question
The stated primary outcome is whether the Modified Ashworth Scale (MAS) score changes from immediately before stimulation to immediately after it, within 30 minutes of the intervention. The scale assesses muscle tone, with higher scores representing more rigid muscles and a worse outcome. The registry record does not report the observed scores, the size or direction of any change, or an analysis testing that change.
3. Trial Design
This is a completed, single-group clinical study of transcutaneous electrical stimulation in people with primary lateral sclerosis. The record lists an enrollment of 6 and identifies Nova Southeastern University as the sponsor. Allocation is recorded as NA, and masking is recorded as none. The design therefore does not include a randomized or masked comparison with a separate control group. The registry lists the phase as NA.
The intervention is described as one 30-minute stimulation session. Electrode pads are placed on the participant’s back and abdomen and connected to an electrical stimulator. The participant lies on their back, with a pillow under the knees for comfort, while the current is adjusted based on small leg-muscle contractions. The device is then used for the session, after which it is turned off and the pads are removed.
The study description says that participants attend one in-person clinic visit and take part in a telephone interview 24 hours after treatment. The clinic visit includes assessments before, during, and after the intervention, including a neurological examination and measures of spasticity, reflexes, gait, walking speed and endurance, and balance. Participants also rate perceived spasticity before treatment, immediately afterward, and 24 hours afterward.
The primary outcome is the Modified Ashworth Scale, measured at baseline immediately before the intervention and immediately after it, within 30 minutes of the intervention. Other listed outcomes include the Deep Tendon Reflex Scale, the 10-meter Walk Test, the 6 Minute Walk Test, the Tinetti Performance Oriented Mobility Assessment, and the 0-10 Numeric Rating Scale. The record lists 6 outcome measures, but does not report their results. Although the study status is completed, primary completion is recorded as 2024-08-21 and the start date as 2023-08-28; these dates do not substitute for outcome estimates or analysis details.
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 | tSCS Intervention |
|---|---|
| STARTED | 6 |
| COMPLETED | 6 |
| NOT COMPLETED | 0 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: All 6 participants received tSCS intervention
| Characteristic | Unit | tSCS Intervention |
|---|---|---|
| Participants analysed | 6 | |
| Age, Continuous | years | 66 (SD 8.17) |
| Sex: Female, Male: Female | Participants | 3 |
| Sex: Female, Male: Male | Participants | 3 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: United States | Participants | 6 |
| Height | Inches | 69.17 (SD 3.19) |
| Weight | Pounds | 165.5 (SD 24) |
| Time since symptom onset (years) | years | 18.83 (SD 7.00) |
6. Primary Endpoint
The registry lists the primary outcome as Modified Ashworth Scale, measured over Baseline (immediately pre-intervention) and immediately post-intervention (within 30 minutes of intervention)..
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | MAS Points |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the Modified Ashworth Scale (MAS), recorded in MAS points. The registry describes the MAS as an ordinal scale for muscle tone, with values ranging from 0, meaning no increase in muscle tone, to 4, meaning rigid flexion or extension. Ten muscle groups are assessed on both sides, producing a possible overall score from 0 to 80. Higher values indicate more rigid muscles and are defined in the record as a worse outcome.
The endpoint is measured at baseline, immediately before the intervention, and immediately after the intervention, within 30 minutes of it. This timing makes the primary question a short-term, within-participant comparison: whether the recorded MAS score differs between the pre-intervention and immediate post-intervention assessments. It does not, by itself, address whether any change persists or how it relates to changes in walking, balance, or other outcomes.
Using a standardized scale allows muscle tone to be recorded in a structured way across the assessed muscle groups. However, the scale is ordinal: its categories indicate ordered levels, but the intervals between categories are not necessarily equal. The registry describes the outcome summary parameter as a mean with a standard deviation. Those summaries can describe the recorded scores, but their interpretation should account for the scale’s ordered categorical structure and the small enrollment. No baseline or post-intervention MAS values, mean change, variability estimate, or statistical comparison is reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record defines a clinically focused question: whether the Modified Ashworth Scale score changes from immediately before stimulation to immediately afterward. It describes a single-group design, with no concurrent control group, and lists enrollment as 6. These design features are essential to interpreting any apparent pre-to-post difference. A change over time in the observed group would be a description of what happened around the intervention, not by itself evidence that stimulation caused the change.
Most importantly, the record does not report the observed primary outcome scores or an analysis of them. There is no posted mean at either assessment, mean change, standard deviation for the outcome, confidence interval, or test result. The registry also lists 0 analyses. As a result, the magnitude, direction, and precision of any primary outcome change cannot be assessed from the registry record. No conclusion about whether scores changed can be drawn from the outcome definition or the completed status alone.
The study description includes other assessments, such as reflex, gait, walking endurance, balance, and perceived spasticity measures. These identify additional domains considered by the investigators, but their presence in the record is not evidence of an observed result. Results for those outcomes are not reported in the registry record either. The outcome list alone does not establish whether the measures were completed, how their values were summarized, or whether they were analyzed.
Because there is no separate comparison group, the design cannot distinguish a possible intervention-associated change from other influences on repeated measurement. In general, repeat assessments can vary because of measurement variability, participant effort, the assessment context, or changes that occur over time. Those are general interpretive considerations, not claims about what occurred in this study. The registry record does not report information that would allow those influences to be evaluated.
The primary scale is ordinal, while the listed summary parameter is a mean and standard deviation. Those summaries may be familiar, but they can obscure how scores are distributed across ordered categories, especially when enrollment is limited. The record does not provide individual values or a distribution, so it is not possible to inspect whether scores cluster at particular levels or whether a mean adequately reflects the observations.
The absence of results is different from a finding of no change. It means the registry record does not provide the data needed to judge whether the observed scores changed, how large any change might have been, or how uncertain an estimate would be. The study’s completed status indicates its administrative status in the record; it does not supply the missing outcome estimates or statistical analyses. Interpretation should therefore remain limited to the registered question, design, measures, and the fact that results are not reported in the registry record.
9. Statistical Methods Explained
The registry describes a single-group study with repeated assessment of the primary outcome before and immediately after the intervention. It lists the primary outcome as a mean of a continuous measure with standard deviation, but the underlying MAS is an ordinal scale. The registry record does not report a statistical analysis plan, a test used for the primary outcome, an estimate of change, or a confidence interval. The concepts below explain general statistical considerations; they should not be read as a description of analyses that were actually conducted.
What does a within-group comparison tell us?
A within-group comparison contrasts measurements from the same participants at different times. Pairing can be useful because each participant serves as their own reference for the change between assessments. This does not create a control group. Without a concurrent comparison condition, a pre-to-post difference cannot isolate the intervention’s contribution from other sources of change or measurement variation. This is a general limitation of uncontrolled before-and-after designs, not a claim that any particular source of variation occurred in this study.
For this study, the primary comparison is between baseline immediately before stimulation and the immediate post-intervention assessment, within 30 minutes of the intervention. The record does not report whether the analysis used participant-level paired values, how the scores were summarized, or how missing assessments would be handled. It also does not report whether an analysis adjusted for any participant characteristics.
How should the scale’s measurement level be considered?
The MAS categories are ordered: higher scores indicate more muscle rigidity, and the registry defines the possible scale range as 0 to 4 for each assessed muscle group. Ordered categories have a meaningful ranking, but the distance between adjacent categories is not necessarily equal. A mean treats the score scale as if numerical differences can be averaged. That can be a useful descriptive summary in some settings, but it may not capture the distribution or the frequency of particular score categories.
For an ordinal outcome, analysts may consider summaries that retain category information, or statistical methods designed for ordered responses. Which method is appropriate depends on the actual data, study question, and analysis plan. The registry record does not state that any particular alternative method was used or planned. It would be inappropriate to attribute an unreported method to the investigators.
What does a standard deviation describe?
In general, a standard deviation describes how dispersed individual measurements are around their mean. It is not the same as uncertainty in the estimated mean or in an estimated change. A confidence interval is a range of values that, under the assumptions of the analysis, conveys the uncertainty around an estimate. Interpreting a confidence interval requires knowing the estimate, the method used to calculate it, and the assumptions behind that method. No standard deviation or confidence interval for the primary outcome is reported in the registry record.
With a small enrollment, individual observations can have a substantial influence on summaries and estimates. This is a general statistical consideration; the record does not provide individual participant measurements, so their influence cannot be assessed. A limited sample also makes it especially important to describe uncertainty rather than rely only on a point estimate. No point estimate or uncertainty interval is posted for the primary endpoint.
What role does a significance test play?
A significance test, when used, evaluates how compatible the observed data are with a specified statistical null model under the test’s assumptions. A p-value does not measure the size or clinical importance of an effect, and it does not establish causation. A p-value also does not replace an estimate and an interval describing its precision. The registry record does not report a p-value, a test statistic, a named test, or a prespecified significance threshold for the primary outcome.
The sample-size assumptions described in the record concern 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. The stated effect to detect is a fraction of the observed effect. These are planning assumptions, not an analysis of this single-group study and not evidence of observed power. The record does not give a protocol sample-size justification or establish that this illustration was used to design the trial.
Why can over-dispersion matter?
In general, over-dispersion occurs when observed variability is greater than a statistical model expects. If a model assumes less variability than is present, standard errors may be too small and intervals or tests may convey too much precision. Whether over-dispersion is relevant depends on the outcome and model. The registry record does not report a model or outcome distribution, so it is not possible to assess this issue for the study’s data.
Overall, the record provides enough information to identify the intended primary measure and its timing, but not to reproduce or evaluate an analysis. The statistical method, handling of missing observations, estimate of change, uncertainty, and inferential results are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists the MAS as the primary outcome and includes several other measures: reflexes, walking performance, walking endurance, balance, and perceived spasticity. Looking at multiple outcomes can create a multiplicity issue when statistical tests are conducted, because the chance of at least one apparently notable result can increase as more tests are considered. This is a general statistical concern, not evidence that the investigators conducted multiple tests or selected results after seeing the data.
The record lists 6 outcome measures, but reports 0 analyses. It does not state whether any multiplicity adjustment was planned, whether outcomes were ordered in a testing hierarchy, or whether the secondary measures were intended to be descriptive or inferential. Such details are not reported in the registry record. Without results or analysis details, it is not possible to assess the effect of multiplicity on any reported inference.
The registry record also does not report the number of participants with an observed value at each assessment, participant flow, withdrawals, or reasons for missing measurements. It does not state how missing data were handled or whether all enrolled participants were included in each analysis. Consequently, the completeness of the primary endpoint and secondary outcomes cannot be evaluated from the record.
Likewise, the record does not define an analysis population, such as a set based on enrollment, treatment received, or availability of outcome measurements. It does not report exclusions from analysis or how participants who did not complete an assessment were treated. These omissions do not establish that data were missing or that participants were excluded; they mean those details are not reported in the registry record. The completed status and the enrollment figure do not resolve these analysis questions.
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 |
|---|---|---|---|
| Transcutaneous Electrical Stimulation to Reduce Spasticity in PLS | 0 | 6 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Transcutaneous Electrical Stimulation to Reduce Spasticity in PLS | 0 of 6 |
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 |
|---|---|
| Transcutaneous Electrical Stimulation to Reduce Spasticity in PLS | 0 of 6 |
The registry reports serious adverse events for the transcutaneous electrical stimulation group. It lists 6 participants at risk for serious adverse events and 0 serious adverse events. It also lists 6 participants at risk for other adverse events and 0 other adverse events, with 0 deaths. No serious adverse event terms are listed.
These are the safety figures recorded for the study, not evidence that the intervention is free of risk. A zero count means that no events of the listed type are reported in this group in the registry record. With enrollment listed as 6, the observations cover a limited group and cannot establish how frequently uncommon events might occur in a broader population. The record does not provide further detail about the method or duration of adverse-event monitoring, event definitions, or whether all participants completed safety follow-up.
The study description includes an in-person clinic visit and a telephone interview 24 hours after treatment, but the safety figures should not be interpreted as covering follow-up beyond what the registry record describes. The available entries do not permit a comparison of safety with another treatment or with no intervention, because there is no concurrent comparison group. They also do not establish causation or rule out events that were not reported. This is a reading of the registry’s event counts, not medical advice.
12. What the Result Does, and Does Not, Mean
This study addresses a focused, short-term measurement question: whether the MAS score differs between the assessment immediately before stimulation and the assessment immediately after it. The registry record describes the intervention and the timing of these measurements, and identifies a group of people with PLS. It also records the study as completed and lists enrollment as 6. These details establish what was intended to be studied, but they do not reveal what happened to the outcome scores.
The primary results are not reported in the registry record. There is no posted estimate of the change in MAS score, no reported variability for the observations, and no statistical analysis or confidence interval. Therefore, the available record cannot show whether the outcome changed, in which direction it changed, or how precisely a change was estimated. Missing results should not be interpreted as either a positive finding or a finding of no difference.
Even if a pre-to-post change were reported, the single-group design would limit causal interpretation. There is no concurrent control condition against which to distinguish a change associated with the intervention from change that could arise from repeated assessment or other influences. That general design limitation does not tell us whether any such influence affected these participants; it identifies what the design cannot separate.
The endpoint also has a specific scope. The primary assessment is conducted immediately after the session, within 30 minutes of the intervention. It does not, by itself, address persistence of any change beyond that assessment. The study description mentions a telephone interview 24 hours after treatment and several secondary measures, but results for those measures are not reported in the registry record. Their inclusion does not establish any observed effect on walking, balance, reflexes, or perceived spasticity.
The most supportable interpretation is therefore limited: this is a completed, small, uncontrolled study with a defined primary outcome and assessment schedule, while its outcome estimates and analyses are absent from the registry record. The record can inform readers about the study’s question and methods as registered, but it does not support a conclusion about the size, precision, durability, or cause of a clinical change.
13. Why This Trial Matters Statistically
Statistically, this trial matters because it illustrates the difference between a clearly described research question and an interpretable result. The registry identifies a target population, a defined stimulation session, a primary scale, and the timing of its assessments. Those details help readers understand the intended comparison: MAS scores before and immediately after the intervention in a single group. But without the observed scores and an analysis, the effect and its uncertainty cannot be evaluated.
The design also highlights the limits of before-and-after evidence. Measuring the same participants at different times can describe within-person change, but without a separate comparison group it cannot isolate the effect of the intervention from other possible influences. This is especially important when a question concerns a short-term response and the outcome is measured soon after treatment. The record’s design information should therefore shape the strength of any interpretation, independently of whether a numerical change might eventually be reported elsewhere.
The primary outcome is an ordinal measure, while the record identifies a mean and standard deviation as the summary approach. This is a useful point for statistical scrutiny: the type of outcome should inform the choice and interpretation of summaries and models. A mean can compress the data into a single value, while the underlying category distribution may carry information that the mean does not show. The record does not provide the distribution or analysis, so that consideration cannot be resolved for this study.
Finally, the registry’s completed status is not a substitute for posted results. The distinction between study completion and result reporting matters for transparent evidence assessment. Readers can identify what was planned and which outcomes were named, while recognizing that the record does not report estimates, uncertainty, analysis populations, or missing-data handling. These gaps constrain what can be learned statistically from the registry entry.
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.
Several limitations specific to this record constrain interpretation. The study is recorded as single-group, with allocation NA and masking none. It therefore has no concurrent control group and no randomized comparison. Any reported pre-to-post change would be descriptive of the group over the assessment interval; the design could not by itself attribute that change to stimulation.
Enrollment is listed as 6, and the registry record does not report participant characteristics beyond the condition of primary lateral sclerosis. Eligibility criteria, baseline clinical profiles, and other details that could help readers understand who took part are not reported in the registry record. With limited enrollment, individual observations may be influential, while the absence of participant-level data prevents assessment of that possibility.
The primary endpoint is an ordinal scale, but its summary parameter is listed as a mean with standard deviation. The record does not provide score distributions, individual measurements, or a justification for the summary approach. It also does not report an analysis method, confidence interval, test result, or estimate of change. Thus, neither the result nor its precision can be assessed.
The registry lists additional outcomes but does not provide their results or say how multiplicity was handled. It also does not report participant flow, missing outcome data, the analysis population, or the handling of missing observations. These details are important for judging whether the reported outcomes, if available, represent the enrolled group and how robust the estimates might be.
Finally, the primary endpoint is assessed immediately after the session. The study description includes a 24-hour telephone interview, but the registry record does not report the results or details of longer follow-up. The immediate endpoint therefore cannot establish the duration of any change. Taken together, the missing results and analysis information, small enrollment, ordinal outcome, and uncontrolled design sharply limit the conclusions that can be drawn from this registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Transcutaneous Electrical Stimulation for Spasticity in Patients With Primary Lateral Sclerosis — NCT06012110.
- Registry record last updated 2026-08-25; status last verified 2026-07.
- Results first posted 2026-08-25.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes a completed, single-group study of transcutaneous electrical stimulation for spasticity in people with primary lateral sclerosis. It lists enrollment as 6, the sponsor as Nova Southeastern University, and the primary outcome as the Modified Ashworth Scale, measured immediately before and immediately after a 30-minute stimulation session. Higher MAS scores indicate more rigid muscles and a worse outcome.
The record also lists secondary measures covering reflexes, walking, balance, and perceived spasticity. It reports 0 serious adverse events, 0 other adverse events, and 0 deaths for the recorded group. However, primary and secondary outcome results, statistical analyses, uncertainty estimates, missing-data handling, and analysis populations are not reported in the registry record. The design has no concurrent control group, so the registered question is a within-group before-and-after comparison rather than a randomized treatment comparison.