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 Treating Non-epileptic Seizures Using Magnetic Brain Stimulation (NCT02796924), a na na study. The primary outcome is Number of Weekly Psychogenic Non-epileptic Seizure-events.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02796924 |
| Phase | NA |
| Condition | Nonepileptic Seizures |
| 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 Manitoba |
| Results posted | Yes |
2. Clinical Question
Population
The registry describes patients with psychogenic non-epileptic seizures, also called PNES, and lists nonepileptic seizures as the condition. The enrollment was 10. The registry does not give additional details about participant characteristics, eligibility criteria, or the diagnostic process, so the population represented by those enrolled cannot be described more specifically from this record.
Intervention
The intervention was a device-based course of repetitive transcranial magnetic stimulation, or rTMS. The arm description specifies 30 sessions of high-frequency stimulation at 20Hz over the right temporal-parietal junction, using a MagStim Rapid2 machine. The registry summary frames the purpose as investigating whether this approach is feasible for decreasing PNES episode frequency; it does not report treatment results.
Comparator
The record describes a single group called Patients, with no control group or alternative treatment listed. Allocation is recorded as NA, and the study model is SINGLE GROUP. Consequently, the registry does not describe a randomized, like-for-like comparison from which an effect relative to a concurrent control can be estimated.
Primary question
The primary endpoint is the number of weekly psychogenic non-epileptic seizure-events, recorded using seizure logs. The stated timeframe is one week and three months post-rTMS treatment. The question is whether the recorded frequency after treatment is consistent with a change in weekly events. The registry record does not report the observed means or standard deviations, nor an analysis comparing the time points.
3. Trial Design
This is a completed, single-group study sponsored by the University of Manitoba. The registry lists the study start as 2016-06 and primary completion as 2019-04. It records enrollment of 10 and identifies the study model as SINGLE GROUP. The phase is listed as NA. These design details describe the registry record; they do not establish how many participants completed treatment or contributed data to the primary endpoint.
The intervention is described as 30 sessions of high-frequency repetitive stimulation at 20Hz. Stimulation was applied over the right temporal-parietal junction using a MagStim Rapid2 machine. The registry classifies the intervention as a device. The brief summary says the study was intended to investigate feasibility of using rTMS to decrease PNES episode frequency. The record does not provide further details about the treatment schedule, adherence, or how feasibility was defined.
There is no comparator arm in the listed design. Allocation is NA and masking is NONE. As a result, the design does not provide a concurrent control group for separating treatment-associated change from other changes over time. An observed pre- and post-treatment difference, if one were reported, would therefore be a within-group observation rather than a randomized treatment contrast.
The registry lists one primary outcome measure and zero analyses. It names the primary measure, unit, summary type, dispersion, and timeframe, but does not report numerical outcome results. The statistical analysis plan, including the handling of repeated measurements, missing observations, and any adjustment for baseline values, is not reported in the registry record. Enrollment alone should not be treated as the number analyzed for the primary endpoint.
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 | Patients |
|---|---|
| STARTED | 10 |
| COMPLETED | 10 |
| 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.
| Characteristic | Unit | Patients |
|---|---|---|
| Participants analysed | 10 | |
| Age, Continuous | years | 44.9 (SD 8.0) |
| Sex/Gender, Customized: Gender – Female | Participants | 7 |
| Sex/Gender, Customized: Gender – Male | Participants | 3 |
| Sex: Female, Male: Female | Participants | 8 |
| Sex: Female, Male: Male | Participants | 2 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| 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 | 2 |
| Race (NIH/OMB): More than one race | Participants | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 7 |
| Region of Enrollment: Canada | Participants | 10 |
| Number of weekly seizure-events | events | 8.1 (SD 6.0) |
6. Primary Endpoint
The registry lists the primary outcome as Number of Weekly Psychogenic Non-epileptic Seizure-events, measured over One week and three months post-rTMS treatment.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | events |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the number of weekly psychogenic non-epileptic seizure-events, measured in events and recorded using seizure logs. It is specified as a mean with standard deviation, which treats the outcome as a continuous measure for reporting purposes. The timeframe is one week and three months post-rTMS treatment. The registry does not further explain the timing or collection procedure for these observations.
Weekly event frequency is relevant to the stated study aim because the brief summary focuses on whether rTMS can decrease the frequency of PNES episodes. A count over a defined period gives a direct description of the recorded event burden during that period. The mean conveys the average recorded weekly frequency for the analyzed group; the standard deviation describes how dispersed individual measurements are around that average. Neither summary alone describes the full distribution of event counts.
For repeated measurements, the relation between a participant’s observations at different times matters when estimating change and its uncertainty. The record does not report a numerical mean, standard deviation, or estimated change at either stated post-treatment timepoint. It also does not report an analysis comparing the observations across time. Accordingly, the endpoint’s definition is available, but the magnitude and precision of any observed change cannot be assessed from the registry results described in this record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically relevant measurement goal: weekly seizure-event frequency after rTMS. It does not, however, report numerical results for that endpoint. No mean or standard deviation is listed, and no estimated change, confidence interval, or statistical test is reported. There is therefore no posted endpoint estimate to interpret for magnitude, direction, or precision. The study’s stated aim should not be mistaken for evidence that the intended decrease occurred.
The single-group design shapes what any future or unreported within-group result could establish. A change between observations after treatment would describe the group’s recorded experience over time. Without a concurrent control group, that change cannot by itself isolate an effect attributable to rTMS. Changes could also reflect time-related variation, changes in recording, or other influences; the registry does not assess these possibilities. This is a design limitation, not a conclusion about what happened to participants.
Masking is recorded as NONE, and the outcome relies on seizure logs. The record does not describe any independent verification of those logs or the procedures used to reduce recording or assessment bias. That leaves uncertainty about how consistently events were captured, but the available information does not establish that the logs were inaccurate.
The registry lists enrollment of 10. That number does not show how many participants contributed endpoint observations at each stated timepoint. The number analyzed, the amount of missing endpoint data, and the reasons for any missingness are not reported in the registry record. Without these details, the completeness and representativeness of any endpoint data cannot be judged.
The registry’s safety counts should also be interpreted separately from the efficacy endpoint. It records zero serious adverse events among 10 at risk, nine affected by other adverse events among 10 at risk, and zero deaths among 10 at risk. The record does not list the serious adverse-event terms or describe the other adverse events. These counts describe what was entered in the record; they do not supply an estimate of seizure-frequency change or a comparative safety assessment.
The record marks the study completed, but completion status does not fill the gap in posted outcome results. The primary endpoint remains defined, while its observed values and analysis are not reported. Consequently, the registry supports a description of the question and design, but not a conclusion about the size, precision, or causal interpretation of an endpoint effect.
9. Statistical Methods Explained
The statistical methods that can be described are limited by what the registry reports. It specifies a continuous primary outcome summarized as a mean with standard deviation, but lists zero analyses. No model, test, confidence interval, or analysis population is reported in the registry record. The explanations below describe general statistical principles relevant to this endpoint; they are not claims about methods used in this study.
What does a mean describe?
For a continuous outcome, the mean is the arithmetic average of the observed values in the group being analyzed. Here, the intended observations are weekly counts of seizure-events. A mean can provide a concise description of the group’s average recorded frequency, but it does not show whether most participants had values near that average or whether a smaller number of larger values influenced it. A mean is most informative when read alongside the spread of observations and details about how the measurements were collected.
What does the standard deviation describe?
The standard deviation describes the dispersion of individual observations around the mean. A relatively small standard deviation indicates values are more concentrated around the average; a larger one indicates more spread. It is not the same as the uncertainty in the estimated mean. The standard error and a confidence interval address uncertainty in an estimate, and would depend on the analysis and available observations. Neither a standard error nor a confidence interval for the primary endpoint is reported in the registry record.
Why can event counts need special consideration?
Weekly seizure-event measurements are counts, even though the registry classifies the endpoint as continuous and specifies a mean and standard deviation. In general, count data may be skewed, may include many low values, or may have variability that differs from what a simple model assumes. Over-dispersion is a general statistical term for variability greater than a model expects. If present, it can make uncertainty estimates from an overly restrictive model unreliable. The record does not provide the observed distribution or name a count-data model, so it is not possible to determine whether over-dispersion occurred or how it was handled.
How should repeated timepoints be handled?
The endpoint timeframe names one week and three months post-rTMS treatment. When measurements are collected at more than one time from the same participant, those observations are generally correlated: a participant’s measurements may be more alike than measurements from different participants. General methods for repeated observations account for this within-participant relation when estimating change and uncertainty. Treating repeated observations as unrelated can misstate precision. The registry does not report how measurements at these timepoints were analyzed, whether they were compared with a baseline measure, or whether a repeated-measures method was used.
What would a confidence interval add?
In general, a confidence interval expresses the uncertainty around an estimated quantity under the assumptions of the analysis. It helps distinguish a comparatively precise estimate from one compatible with a broad range of values. A point estimate alone does not show its precision, and a significance test alone does not show the plausible magnitude of an effect. No confidence interval or point estimate for the primary outcome is reported in the registry record, so neither magnitude nor precision can be evaluated.
What do the planning illustrations represent?
The registry describes sample-size assumptions for planning illustrations based on the observed effect, not on the trial’s own design. The stated assumptions include a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. These are hypothetical planning assumptions, not a description of the single-group study’s design or an observed-power calculation. Sample-size illustrations are planning aids and do not provide evidence that an effect was detected. The registry does not report a sample-size justification for this trial.
In general, a recalculation from posted summary statistics would be distinct from the sponsor’s own analysis and would be unadjusted if based only on summary values. No such endpoint summary values or sponsor analysis are reported, so there is no recalculated endpoint result to interpret. The registry record does not report the analysis method, model assumptions, hypothesis tests, or any sponsor-led statistical result.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome measure, the number of weekly psychogenic non-epileptic seizure-events, with observations described at one week and three months post-rTMS treatment. It does not report an analysis plan specifying how those timepoints were to be compared, whether one was designated as the principal comparison, or how multiplicity across outcomes or timepoints would be handled. Although one primary measure is listed, that alone does not establish the full set of analyses performed.
The registry records zero analyses. A statistical analysis plan, including model choice, covariate adjustment, treatment of repeated measurements, and inferential procedures, is not reported in the registry record. It is therefore not possible to assess whether analyses were prespecified, whether any were exploratory, or how results were selected for reporting.
The record does not give the number of participants with endpoint data at each timepoint, the amount of missing data, or reasons for missing observations. It also does not describe an approach to missing data, such as whether analyses used only available observations or applied an imputation method. These details matter because an analysis based on incomplete observations may represent a different subset of participants at different times. Without information on missingness and its handling, the effect of incomplete data on an estimate cannot be evaluated.
An analysis population is not specified. Enrollment of 10 does not establish the number included in an endpoint analysis, nor whether all enrolled participants began or completed the intervention. The registry does not report adherence or any population definition such as an intention-to-treat set. These gaps limit assessment of both the analytic sample and the robustness of any result.
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 |
|---|---|---|---|
| Patients | 0 | 10 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Patients | 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 |
|---|---|
| Patients | 9 of 10 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Patients |
|---|---|---|
| Headache | Nervous system disorders | 6 of 10 |
| Fatigue | Nervous system disorders | 4 of 10 |
| Vivid dreams | Nervous system disorders | 4 of 10 |
| Pain | Nervous system disorders | 1 of 10 |
| Nausea | Nervous system disorders | 1 of 10 |
| Migraine | Nervous system disorders | 1 of 10 |
The registry reports serious adverse events for the Patients group as zero affected among 10 at risk. It reports other adverse events as nine affected among 10 at risk, and deaths as zero among 10 at risk. These are recorded counts for the group; they are not comparative estimates because no control group is listed.
The serious adverse-event terms are not listed in the registry record. The descriptions or types of other adverse events, their severity, timing, and relationship to treatment are also not reported. As a result, the count for other events cannot be used to characterize what those events were or how important they were. Likewise, a zero count in the serious-event and death categories records no events entered in those categories; it does not establish that no risk exists.
The number at risk indicates the denominator recorded for each safety category, but the registry does not explain the monitoring period or whether all participants were followed for the same duration. The safety counts should therefore be read as registry-reported observations with limited context, not as a complete description of the intervention’s safety or as evidence from a controlled comparison.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a completed single-group study was intended to investigate rTMS feasibility for decreasing PNES episode frequency. It specifies a treatment course and a primary measure based on weekly seizure-event logs. It does not report the primary endpoint’s observed means or standard deviations, an estimated change, or a statistical analysis. Thus, the posted record does not show how seizure frequency changed after treatment or how precise an estimate might be.
The absence of a concurrent comparator is important to interpretation. Even if within-group measurements had shown a change, this design would not by itself distinguish a treatment-associated change from other changes over time. A comparison against a control group can help address that question, whereas a single-group before-and-after pattern cannot provide the same protection against alternative explanations. The record does not report a randomized comparison.
The listed safety observations are limited to counts: zero serious adverse events among 10 at risk, nine with other adverse events among 10 at risk, and zero deaths among 10 at risk. The record does not identify the other events or provide comparative safety data. These counts do not answer the primary seizure-frequency question and should not be used to infer an overall benefit or harm balance.
The study can therefore be described as a completed investigation with a defined outcome and a stated feasibility aim, but its registry entry does not permit an assessment of efficacy, the magnitude of change, or its precision. The details needed to evaluate missing data, analysis choices, and participant-level outcome completeness are also absent. These limits concern what can be concluded from the registry record, rather than proving that no other analyses or information exist outside it.
13. Why This Trial Matters Statistically
This study is statistically instructive because it makes the distinction between a defined research question and a reported result especially clear. The registry names a primary outcome, its units, summary type, and timing. Those details help identify what investigators intended to measure. But without reported observations and an analysis, the endpoint cannot answer whether the recorded frequency changed, by how much, or with what uncertainty.
The single-group structure also illustrates why design determines the scope of inference. Repeated measurements can describe change within a group, but without a concurrent comparison group they do not isolate the cause of that change. Statistical analysis cannot fully compensate for the absence of a control condition. This distinction is central when interpreting studies that measure outcomes before and after an intervention.
The outcome is a count summarized as a mean and standard deviation. General statistical considerations for counts include distribution shape and possible over-dispersion, while repeated observations raise questions about within-participant correlation. The registry does not say how these matters were handled. Recognizing such questions is useful for understanding why a statistical plan and sufficiently detailed reporting are necessary for readers to evaluate an estimate.
Finally, a completed status, an enrollment figure, and safety counts do not substitute for primary outcome results. The record provides enough information to characterize important aspects of the design, but not enough to estimate the primary effect or judge its precision. This is a practical reminder that transparency about methods, analysis populations, missing observations, and outcome estimates is essential to statistical interpretation.
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 central limitation for interpreting this specific registry record is that it does not report numerical results for the primary endpoint. Although the outcome is named and its summary measure is specified, there are no posted means, standard deviations, estimated changes, confidence intervals, or tests. The record therefore cannot support a quantitative assessment of the endpoint.
The study is listed as single-group, with allocation recorded as NA and no comparator described. This prevents a like-for-like comparison with a concurrent control group. Masking is recorded as NONE, and the outcome is based on seizure logs. The registry does not describe independent outcome verification or measures to reduce reporting or assessment bias.
The timing and analysis of observations are not fully described. The timeframe names one week and three months post-rTMS treatment, but the record does not explain the collection schedule in greater detail, whether baseline measurements were used, or how repeated observations were compared. It also does not identify a statistical model or analysis plan.
Enrollment is recorded as 10, but the number contributing data at each timepoint, the number completing treatment, and the handling of missing observations are not reported in the registry record. Participant characteristics and details of eligibility are also not available in the information recorded. These omissions limit assessment of the analyzed population and the applicability of any unreported findings.
Safety reporting is similarly limited: the record gives counts but does not name serious adverse-event terms or describe the other adverse events, monitoring period, or treatment relationship. These limitations constrain interpretation of both outcomes and safety, without establishing what the unreported results or event details would show.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Treating Non-epileptic Seizures Using Magnetic Brain Stimulation — NCT02796924.
- Registry record last updated 2020-09-30; status last verified 2020-03.
- Results first posted 2020-09-30.
- 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 University of Manitoba sponsored this completed, single-group study of rTMS for nonepileptic seizures. The registry lists enrollment of 10, with a study start of 2016-06 and primary completion of 2019-04. The intervention description specifies 30 sessions of 20Hz stimulation over the right temporal-parietal junction using a MagStim Rapid2 machine. Masking is recorded as NONE, and no comparator group is listed.
The primary endpoint is the mean number of weekly psychogenic non-epileptic seizure-events, with standard deviation, recorded using seizure logs at one week and three months post-rTMS treatment. The registry does not report endpoint results or an analysis; it lists zero analyses. Safety counts are zero serious adverse events among 10 at risk, nine other adverse events among 10 at risk, and zero deaths among 10 at risk. Event descriptions are not reported in the registry record.