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 A Pilot Study of a Non-Invasive Neuromodulation Device for Treatment of Parkinson's Disease (NCT02134795), a na na study. The primary outcome is Motor UPDRS Score (Unified Parkinson's Disease Rating Scale).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02134795 |
| Phase | NA |
| Condition | Parkinson's Disease |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 6 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Scion NeuroStim |
| Results posted | Yes |
2. Clinical Question
Population
The registry describes people with mild to moderate Parkinson's disease. Six participants were enrolled. Further eligibility criteria and participant characteristics are not reported in the registry record, so the enrolled group cannot be characterized more fully from this record.
Intervention
The intervention was caloric vestibular stimulation using the TNM Device. The plan allowed up to 3 sessions of 19 minutes each across as many as 2 study visits. The first visit was described as including 2 sessions separated by 1 hour, with 1 session during a second visit.
Comparator
There was no separate control group. The study used a single-group design, with motor scores planned to be measured before and after device use. Those repeated measurements were intended to compare each participant's post-stimulation scores with that participant's baseline, not with outcomes in a parallel group.
Primary question
The primary question was whether motor scores on the Unified Parkinson's Disease Rating Scale (UPDRS) changed at scheduled times after caloric vestibular stimulation relative to baseline. The scheduled assessments extended from 25 minutes through 220 minutes. The registry states that the study was halted before any participant could complete this endpoint; therefore, it contains no primary outcome data with which to answer the question.
3. Trial Design
This was a single-center, open-label, single-group pilot study of caloric vestibular stimulation in Parkinson's disease. The registry lists the phase as NA, allocation as NA, and masking as none. The intervention was the TNM Device, classified as a device. With no distinct comparator group, the design was not a randomized treatment comparison.
The registry describes a planned schedule of up to 3 sessions of 19 minutes each, across as many as 2 study visits. At the first visit, 2 sessions were planned, separated by 1 hour; a single session was planned at a second visit. These descriptions concern the planned intervention schedule. The record does not report how many sessions any participant actually received or how many visits were completed.
The study started in 2014-05, had a primary completion date of 2014-09, and is listed as terminated. Six participants were enrolled. The registry explicitly states that the study was halted early before any participants could complete the primary endpoint. The reason for termination and the timing of the halt are not reported in the registry record.
A pilot study can be used to explore procedures or collect preliminary observations, but its design does not by itself establish a treatment effect. Here, the absence of a control group would also limit interpretation of any observed before-and-after change: time, repeated testing, expectation, and other factors could contribute to a change. In this case, there are no endpoint observations to interpret. The registry does not report the intended eligibility criteria in detail, the rationale for the enrollment target, or a statistical analysis plan.
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 | Caloric Vestibular Stimulation (CVS) |
|---|---|
| STARTED | 6 |
| COMPLETED | 6 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: The study was halted early before any of the participants could complete this endpoint. Therefore, there is no outcome data to analyze.
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 | Caloric Vestibular Stimulation (CVS) |
|---|---|---|
| Participants analysed | 6 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 6 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex/Gender, Customized: Unknown | Participants | 6 |
| Region of Enrollment: United States | Participants | 6 |
6. Primary Endpoint
The registry lists the primary outcome as Motor UPDRS Score (Unified Parkinson's Disease Rating Scale), measured over Changes in motor score at 25, 50, 75, 100, 130, 160 and 220 minutes relative to baseline.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was the motor score on the Unified Parkinson's Disease Rating Scale (UPDRS). The registry describes a motor examination before device use as baseline, followed by planned assessments after device sessions. Scores were to be recorded at 25, 50, and 75 minutes after the first use, and at 100, 130, 160, and 220 minutes after a second use. The endpoint was framed as change in motor score at these times relative to baseline. The registry also planned a video recording of the motor examination at baseline and during the final test.
In general, a repeated motor assessment can describe how a measured score changes over time within a participant. A baseline reference gives context for interpreting subsequent measurements, while multiple post-baseline times can distinguish an immediate observation from later observations. That is the general purpose of the schedule described in this record; the registry does not report how any changes were to be combined into a single summary or tested statistically.
The endpoint was not completed by any participant, according to the registry. No motor scores, changes from baseline, variability measures, or analysis results are reported. As a result, the intended measure cannot be used to estimate the size or precision of any change in this study.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical fact is that the primary endpoint has no outcome data. Although six participants were enrolled, the registry states that the study was halted before any participant could complete the motor UPDRS endpoint. Enrollment therefore cannot be treated as the number of participants with usable primary outcome measurements. No endpoint estimate, confidence interval, hypothesis test, or participant-level trajectory is reported.
The planned endpoint involved repeated motor scores relative to baseline. Had those measurements been completed, the results would have described changes over scheduled times in this group. However, the record contains no values from which to judge either the direction or magnitude of change. It also provides no estimate of between-participant variability or measurement precision. No conclusion about the pattern of motor scores can be drawn from the planned schedule alone.
The single-group design is important to interpretation even apart from the missing endpoint. A before-and-after comparison in one group does not separate a possible intervention-associated change from other influences on scores. General examples include natural variation over time, familiarity with repeated testing, and expectations in an open-label study. These are design considerations, not documented explanations for any result in this trial; no primary result exists to explain.
The registry lists no analyses. It does not report a statistical analysis plan, an analysis population, a method for handling missing outcome data, or an inferential result. The reason the endpoint was not completed is described only as early halting; the reason for that halt is not reported in the registry record. It is therefore not possible to determine from this record whether missing endpoint data arose from a particular operational issue, participant-level circumstance, or another cause.
The adverse-event record lists six participants at risk and zero affected for serious events, other events, and deaths. These are counts in the registry's adverse-event summary, not evidence about the unmeasured primary motor outcome. The record does not state the adverse-event observation window or provide event terms. Zero recorded events in a small enrolled group does not establish that an intervention has no risks.
Overall, the posted results document enrollment, early termination, an uncompleted primary endpoint, and the recorded adverse-event counts. They do not provide evidence for estimating the intervention's effect on motor scores. The absence of a reported effect is not the same as an estimate showing no change; it reflects that the intended endpoint was not observed.
9. Statistical Methods Explained
No statistical analyses are reported for the primary endpoint. The registry lists zero analyses, and it supplies no outcome values, estimates, confidence intervals, or p-values. The intended repeated-measures schedule can be described, but a statistical method actually used to analyze those measurements is not reported in the registry record.
What would a change-from-baseline analysis describe?
In general, a change-from-baseline analysis compares a participant's measurement after an intervention with that participant's earlier measurement. Repeating this at several times can describe the time course of the measured outcome. Because measurements from the same participant are related, an analysis should account for that dependence rather than treating each assessment as though it came from a different person. This is a general statistical principle, not a claim about an analysis conducted in this trial.
The record specifies baseline and seven planned post-baseline assessment times: 25, 50, 75, 100, 130, 160, and 220 minutes. It describes assessments around a first use and a second use of the device. It does not report whether a single time point, an overall pattern, or some other summary was intended to serve as the principal statistical contrast. That choice matters because different summaries answer different questions. A selected time point focuses on that assessment; a model of the full sequence uses information across times but requires choices about the form of change and the relationship among repeated measures.
What do estimates and confidence intervals mean?
In general, an estimate describes the effect or difference calculated from observed data. A confidence interval expresses the uncertainty around an estimate under the assumptions of the statistical method. A narrower interval indicates greater precision under that method, while a wider interval indicates less precision. Neither an estimate nor an interval can be recovered from a schedule of planned measurements alone. Since no participant completed the primary endpoint, this record provides neither for motor-score change.
A hypothesis test, when planned and performed, assesses how compatible observed data are with a specified null hypothesis under a statistical model. A p-value is not the probability that a treatment works, and it does not convey the size or practical importance of a change. Here, no primary endpoint data or test result is reported, so there is no p-value to interpret. The registry also does not report a prespecified statistical plan that would identify a null hypothesis or testing procedure.
Why does the design affect the analysis?
In general, a single-group pre-post design can describe within-group change, but it cannot make the same direct contrast as a design with a separate control group. Without a concurrent comparator, changes may reflect influences other than the intervention. Open-label status means that masking was not used; it can also matter when outcomes involve examination or assessment, because awareness of the intervention may influence conduct or scoring. These points explain general design considerations and do not establish that any particular bias occurred in this study.
The registry lists allocation as NA and describes the study as single-group. It therefore does not report a randomized allocation procedure or a like-for-like control comparison. The title and summary describe the project as a pilot study, but a pilot label does not identify a statistical method or justify treating any planned result as confirmatory.
How should planning illustrations be read?
General sample-size calculations estimate how many participants would be needed under specified assumptions to detect a target effect with a chosen statistical approach. The registry's planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the target effect is described as a stated fraction of an observed effect. These are assumptions for a planning illustration, not a description of the single-group trial's allocation or proof of power achieved in the study.
The primary endpoint was not completed, so the record contains no observed motor-score effect from which to base an effect-size estimate for this trial. Any planning illustration that refers to an observed effect cannot turn the missing trial outcome into observed evidence. A hypothetical count of participants per arm for 80% power, if presented as a planning scenario, would not be the number enrolled, an estimate of observed power, or a result of this trial. The trial's own sample-size justification is not reported in the registry record.
The record does not report whether interim analyses were planned or performed, how missing data were to be handled, or whether any sensitivity analyses were specified. General methods for missing data depend on why measurements are missing and on assumptions about the unobserved outcomes. With no completed primary endpoints and no reported analysis plan, there is no basis for selecting or evaluating such an approach for this study.
10. Multiplicity, Missing Data and Analysis Populations
The primary endpoint included assessments at multiple post-baseline times. Repeated assessment creates a multiplicity question if each time is tested separately: conducting several tests can increase the chance of finding at least one apparently notable result by chance. In general, a statistical plan may specify one primary time point, define a combined repeated-measures analysis, or adjust for multiple tests. The registry does not report which approach, if any, was planned. It also reports no analyses, so there are no multiple-testing results to interpret.
The record states that no participant completed the primary endpoint. It does not report the number of participants with partial endpoint measurements, whether any baseline or interim scores were collected, or why participants did not complete the endpoint. It does not describe an imputation method, a complete-case analysis, or another missing-data strategy. The reason for the early halt is not reported in the registry record.
An analysis population is the defined set of participants whose data are included in an analysis. Common approaches can include analyzing participants according to initial assignment or restricting analysis to those meeting specified criteria, but the appropriate approach depends on the design and prespecified plan. The registry does not report a primary analysis population or any completed primary analysis. Since there was no separate randomized allocation and the endpoint was uncompleted, the six enrolled participants should not be assumed to constitute an analyzed endpoint population.
These omissions leave the endpoint's intended handling, multiplicity strategy, and analysis population unknown. They are not evidence that a particular method was or was not used outside the information recorded in the registry.
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 |
|---|---|---|---|
| Caloric Vestibular Stimulation (CVS) | 0 | 6 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Caloric Vestibular Stimulation (CVS) | 0 of 6 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Caloric Vestibular Stimulation (CVS) | 0 of 6 |
The adverse-event summary lists six participants at risk for serious adverse events and zero affected. It also lists six at risk for other adverse events and zero affected. The death count is zero, and no serious adverse-event terms are listed. These are the recorded counts for the caloric vestibular stimulation group.
In general, an at-risk count identifies the group considered in an adverse-event summary, while an affected count records participants with an event in that category. The figures do not provide event rates beyond those counts, and no further safety detail should be inferred from them. The registry does not report the observation period for these counts, the method of event collection, or event-specific descriptions. It also does not state whether the counts cover all participants through the same duration of follow-up.
Zero recorded events in this group means that the registry reports no affected participants in these categories; it does not establish that the intervention has no risk. The group was small, and the primary endpoint was not completed. Safety counts are distinct from motor-score outcomes and cannot answer the primary question about change in UPDRS motor scores. The record also does not report a comparator group against which the adverse-event counts could be contrasted.
12. What the Result Does, and Does Not, Mean
The record establishes that a pilot study of caloric vestibular stimulation using the TNM Device enrolled six participants and was terminated before any participant completed the primary motor UPDRS endpoint. It also records the intended schedule of motor assessments and the adverse-event counts. These registry entries describe the conduct and status of the study, not the effect of the intervention on motor scores.
No primary outcome data are available in the registry record. Consequently, the study does not provide an estimate of change from baseline, an estimate of uncertainty, or a statistical test for the primary question. It cannot show whether motor scores increased, decreased, or remained similar after device use. A missing estimate must not be interpreted as an estimate of no change.
The single-group, open-label design would have limited causal interpretation even if the endpoint had been completed. In general, without a concurrent control group, observed before-and-after changes cannot be separated from other factors that may influence measurements over time. This limitation concerns the design; it does not fill the gap created by the absent outcome data.
The recorded absence of adverse events is also limited to the counts and categories in the registry. It does not establish the absence of risk, and it does not indicate what the unmeasured motor endpoint would have shown. No detailed event terms or observation period are reported.
The appropriate reading is narrow: a small pilot study was initiated, six participants were enrolled, and the planned primary endpoint was not completed before the study was halted. The registry does not report why the study was terminated, a statistical analysis of motor scores, or a basis for judging the intervention's efficacy. The record is therefore informative about the endpoint's incompletion and the limits of the available evidence, but it cannot answer the intended clinical question.
13. Why This Trial Matters Statistically
This study matters statistically because it illustrates the difference between enrollment and an analyzable primary endpoint. Six participants were enrolled, but the registry states that no participant completed the endpoint. The enrollment count alone cannot support an estimate of motor-score change. A planned measurement schedule is not a substitute for observed measurements.
The record also shows why design and outcome availability must be considered together. The study was single-group and open-label, with baseline and repeated post-device assessments planned. Such a design can describe changes within participants if data are collected, but it does not include a separate group to help distinguish intervention-associated change from other influences. Here, the endpoint was not completed, so even a descriptive within-group analysis is unavailable.
For statistical interpretation, the absence of a reported estimate is not a null finding. There is no result demonstrating no change, and there is no result demonstrating a change. This distinction is essential when a trial stops before its primary outcome can be assessed. Likewise, the adverse-event counts are limited observations and should not be mistaken for an evaluation of the motor endpoint or a comprehensive statement about safety.
The registry leaves important interpretive details unreported, including the reason for termination, the analysis plan, missing-data methods, and the intended analysis population. These gaps make it impossible to assess how the primary endpoint would have been analyzed or how any partial measurements might have been handled. The record's statistical value is therefore mainly in clarifying what was planned, what was enrolled, and why no endpoint-based inference can be drawn from the posted results.
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 most direct limitation is that the primary endpoint was not completed by any participant. No motor-score results or analysis estimates are reported. This prevents assessment of the direction, magnitude, and precision of any change at the scheduled times.
Only six participants were enrolled. The registry does not describe their characteristics in detail, so it is not possible to assess how they compare with the broader population of people with Parkinson's disease. Eligibility criteria beyond the brief description are not reported in the registry record. The study was single-center, which also limits what can be learned about how its procedures might perform in other settings.
The design had no separate comparator group and was open label. In general, those features constrain causal interpretation and can matter for measured outcomes, particularly when examinations are repeated. The record does not report any method intended to address those design limitations. It also does not report the number of participants who completed individual intervention sessions or visits, so the extent of intervention exposure cannot be established.
The trial was terminated, but the reason and circumstances of termination are not reported in the registry record. The statistical analysis plan, sample-size justification, analysis population, interim-analysis plans, and missing-data methods are also not reported in the registry record. These omissions prevent evaluation of whether the intended statistical approach was prespecified and how incomplete measurements would have been treated.
Safety information is limited to the recorded counts: six participants at risk and zero affected for serious and other events, with zero deaths. Event details and the observation window are not reported. These limitations mean the registry offers a brief account of enrollment, intended assessments, early termination, and recorded event counts, rather than a completed evaluation of motor outcomes or a comprehensive account of safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Pilot Study of a Non-Invasive Neuromodulation Device for Treatment of Parkinson's Disease — NCT02134795.
- Registry record last updated 2025-05-02; status last verified 2025-04.
- Results first posted 2025-05-02.
- 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
NCT02134795 is a single-center, open-label pilot study of caloric vestibular stimulation using the TNM Device in people with Parkinson's disease. The registry describes a single-group design, lists six participants enrolled, and records the study as terminated. The planned primary endpoint was change in motor UPDRS score from baseline at scheduled times after device use.
The registry states that the study was halted before any participant could complete that endpoint. No motor outcome analyses are reported. The adverse-event summary lists six participants at risk, zero affected for serious and other adverse events, and zero deaths. The reason for termination and the statistical analysis plan are not reported in the registry record.