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 Effectiveness of CES on Emotional and Cellular Wellbeing (NCT03369418), a randomized na study. The primary outcome is HADS Questionnaire Combined Score.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03369418 |
| Phase | NA |
| Condition | Anxiety, Depression |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 44 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of California, Los Angeles |
| Results posted | Yes |
2. Clinical Question
Population
The trial enrolled 44 participants and listed anxiety and depression as its conditions. The registry record does not report further details about participant characteristics or eligibility criteria in the registry record for this analysis.
Intervention
The active intervention was an Alpha-Stim device with active electrodes, described as intended for daily treatment. The active-device description states that its frequency was preset to 0.5 Hz and 100 microampere, with treatment lasting one hour daily.
Comparator
The comparison group received an Alpha-Stim inactive device for daily treatment. Its description says the electrodes were inactive and the device would not transmit anything when turned on. The device display was described as stating 0.5 Hz and 100 microampere.
Primary question
The stated primary outcome was the combined score on the Hospital Anxiety and Depression Scale (HADS), measured after completion of the study, described as one year. The question was whether the combined symptom score differed between the active and inactive device groups. The registry record does not report a single numerical comparison for that outcome.
The investigators’ stated aims also included assessing cellular-health markers. The registry record lists telomere length as a secondary outcome. Its brief summary additionally mentions telomerase activity, but that measure is not listed among the secondary outcomes in the registry record for this analysis. The clinical question therefore includes both symptom measurement and interest in cellular markers, while the reported primary endpoint is the combined HADS score.
3. Trial Design
The registry describes NCT03369418 as a randomized, double-masked, parallel-group trial comparing Alpha-Stim active and Alpha-Stim inactive devices. The listed enrollment was 44. The sponsor was the University of California, Los Angeles. The trial began in 2016-03, reached primary completion on 2018-10-20, and has a status of completed. Its phase is listed as not applicable.
In a randomized design, assignment to groups is determined using a chance-based process rather than being chosen solely by participants or investigators. In a parallel design, each participant is assigned to one group, and the groups are compared. These are general descriptions of the design terms; the registry record does not report further details of the assignment procedure.
The record labels masking as double, but does not specify in the registry record which particular people were masked or how masking was maintained. The descriptions distinguish an active device with active electrodes from an inactive device with inactive electrodes. The inactive-device description states that it would not transmit anything when turned on. The record does not report whether participants or staff could identify assignments, whether masking was assessed, or whether any procedures were used to preserve it.
The active-device description specifies daily one-hour treatment and settings of 0.5 Hz and 100 microampere. The inactive-device description says treatment was daily and that the device display stated those settings, while its electrodes were inactive. These are the descriptions recorded for the devices, not evidence about adherence or the treatment actually received by each participant. Adherence, deviations from the device instructions, and details of follow-up are not reported in the registry record.
The primary completion date and completed status describe the trial’s administrative record. They do not, by themselves, establish how many participants completed treatment or contributed data to each outcome analysis. Those analysis-population details are not reported in the registry record.
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 | Active | Inactive |
|---|---|---|
| STARTED | 16 | 14 |
| COMPLETED | 13 | 11 |
| NOT COMPLETED | 3 | 3 |
Reasons for not completing this period:
| Reason | Active | Inactive |
|---|---|---|
| Withdrawal by Subject | 3 | 3 |
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 | Active | Inactive | Total |
|---|---|---|---|---|
| Participants analysed | 13 | 11 | 24 | |
| Age, Continuous | years | 28.62 (SD 7.29) | 27.09 (SD 5.72) | 27.92 (SD 6.52) |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 13 | 11 | 24 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 3 | 0 | 3 |
| Race (NIH/OMB): White | Participants | 7 | 5 | 12 |
| Race (NIH/OMB): More than one race | Participants | 0 | 2 | 2 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 2 | 3 | 5 |
6. Primary Endpoint
The registry lists the primary outcome as HADS Questionnaire Combined Score, measured over After completion of the study (1 year).
| Element | Registry entry |
|---|---|
| Result type | Least Squares Mean |
| Measure of spread | Standard Error |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the combined HADS score, described as a score on a scale. The Hospital Anxiety and Depression Scale assesses symptoms of anxiety and depression. According to the registry description, its minimum is 0 and its maximum is 52, with higher scores indicating more symptoms. The combined score sums the anxiety and depression scores, and the registry identifies that combined measure as the primary outcome.
A combined score provides one overall measure for the primary comparison, rather than treating anxiety and depression as separate primary endpoints. It is aligned with the stated aim of assessing emotional well-being through symptoms of anxiety and depression. As a general statistical point, defining a primary endpoint gives a trial a central outcome around which the main comparison can be organized. It does not mean that every aspect of emotional well-being is captured by that measure.
The registry gives the timeframe as after completion of the study, described as one year. It reports the outcome parameter as a least-squares mean and the dispersion as a standard error. The registry record does not report the numerical least-squares means, standard errors, group contrast, confidence interval, or a single primary-outcome test in the registry record for this analysis. The primary outcome has several categories or time points and is not reduced to one comparison in the posted statistical summary. Thus, the endpoint’s definition and intended timing are described, but the size and precision of a treatment-group difference cannot be interpreted from a single posted estimate.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized, double-masked, parallel comparison of Alpha-Stim active and Alpha-Stim inactive devices in a trial with enrollment of 44. Its primary outcome is the combined HADS score after study completion, described as one year. The record’s description defines the score and its direction: higher scores indicate more symptoms. These details clarify what the primary measure represents, but they do not state what the groups’ results were.
No numerical primary-outcome estimate, group-specific mean, standard error, confidence interval, or single comparison is reported in the registry record for this analysis. The registry notes that the primary outcome has several categories or time points and is not reduced to one comparison. Without an estimate and its uncertainty, it is not possible to describe the magnitude or precision of a difference between groups from the registry record. A direction of effect, statistical significance, or clinical importance cannot be inferred from the design description or the trial’s completed status.
The registry lists telomere length as a secondary outcome. The brief summary describes an aim to assess telomere length and telomerase activity, but telomerase activity is not included in the listed secondary outcomes in the registry record for this analysis. Numerical results for either cellular measure are not reported in the registry record. The stated research aims therefore should not be mistaken for evidence that any particular change was observed.
The adverse-event figures record no serious events in either group and no deaths. Other adverse events are recorded for both groups: 2 among 13 at risk in the active group and 6 among 11 at risk in the inactive group. These counts describe the registry entries, but without additional detail about event types, timing, severity classifications, or participant-level follow-up, they do not establish the comparative safety profile of the devices.
Overall, the record supports a description of the study design, intervention descriptions, and selected outcome and safety entries. It does not support a numerical conclusion about the primary endpoint or cellular outcomes. A missing comparison is not evidence that the groups were equivalent, nor does it establish that one group had better results.
9. Statistical Methods Explained
The registry labels the primary outcome parameter as a least-squares mean and the measure of dispersion as a standard error. No numerical least-squares means or standard errors are reported in the registry record for this analysis. These labels describe statistical summaries, not the results themselves.
What is a least-squares mean?
As a general statistical explanation, a least-squares mean is a model-based estimate of a group mean. It can reflect adjustment for variables included in a statistical model, whereas a simple arithmetic mean is calculated directly from observed values. The term alone does not reveal which variables, if any, were included in a model. The registry record does not report the model specification, adjustment variables, or analysis method used to obtain the stated least-squares mean. It is therefore not possible to determine from this label alone how adjusted the estimate was or how it relates to the raw group average.
What does a standard error describe?
As a general statistical explanation, a standard error describes the uncertainty of an estimated quantity across repeated samples under a statistical model. It is not the same as a standard deviation, which describes variability among individual observations. A standard error can help convey how precisely a group estimate has been estimated, but it does not by itself provide the full uncertainty for a comparison between groups. A confidence interval for the contrast or a suitable test result would be needed to describe that comparison more directly. No such numerical comparison is reported in the registry record.
Why does the missing comparison matter?
The primary outcome description covers the combined HADS score, and the registry says that the primary outcome has several categories or time points rather than a single reduced comparison. When a result is not condensed to one contrast, the reader cannot identify a single estimate that represents the main comparison from the record’s posted information. The definition of the endpoint remains useful, but it does not substitute for the group estimates, a contrast, and uncertainty around that contrast. The record does not report which categories or time points underlie this issue in the registry record for this analysis.
As a general statistical concept, a confidence interval gives a range of values compatible with the data and the assumptions of the analysis, and conveys precision as well as direction. It is not reported for the primary comparison in the registry record for this analysis. Without the estimate and its interval, the size of any group difference cannot be evaluated. The record also does not report a primary-outcome p-value in those details, so no significance statement can be made.
How should the planning illustrations be read?
The sample-size assumptions describe a planning illustration based on the observed effect, not the trial’s original design. The stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. For non-time-to-event outcomes, the stated quantity is participants per arm for 80% power or another listed power level. These are planning assumptions, not observed trial results. They do not show that the trial had a particular probability of detecting an effect, and they must not be described as observed power.
As a general explanation, such planning exercises ask how many participants might be needed under chosen assumptions to detect a target effect with a chosen probability, if those assumptions hold. When the target is expressed as a fraction of an observed effect, the illustration depends on that effect estimate and should not be treated as an independent confirmation of it. The registry record does not report that these assumptions were used to set the trial’s enrollment target. Its own sample-size justification is not reported in the registry record. No numerical sample-size illustration is cited in this explanatory text.
What is not established by the design labels?
Randomization, masking, and a parallel structure describe important aspects of trial conduct, but do not disclose the analysis plan. The record does not report the statistical model, the specific group contrast, handling of baseline measurements, covariate adjustment, interim analyses, or rules for excluding observations. The registry’s least-squares-mean label does not fill in these details. They are not reported in the registry record.
Likewise, a reported standard error does not show whether uncertainty was calculated with methods suited to the data distribution, nor does the record state whether distributional assumptions were checked. As a general matter, model assumptions and the way missing observations are handled can affect estimates and uncertainty. The registry entries do not describe those choices for this trial.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome is described as a combined HADS score, but the registry notes that it has several categories or time points and is not reduced to one comparison. The registry entries available for this analysis do not identify the categories or time points involved or report a single primary contrast. The registry record does not report how multiple outcome comparisons or time points were handled statistically.
The record lists telomere length as a secondary outcome. The trial summary also mentions telomerase activity as an aim, but that measure is not listed among the secondary outcomes in the registry record for this analysis. The statistical plan for the secondary outcome, and any approach to multiplicity across outcomes, are not reported in the registry record. As a general statistical point, when several outcomes or comparisons are considered, the chance of at least one apparently unusual result can depend on how many analyses are conducted and how they are interpreted. No particular adjustment or testing strategy can be attributed to this trial from the registry entries.
The registry record does not report the number of participants with outcome data, missing-data counts, reasons for missingness, or methods for handling missing observations. It also does not report whether analyses followed the original randomized assignments, were limited to participants who completed treatment, or used another analysis population. These details matter because an analysis based on a subset of enrolled participants may differ from one based on all randomized participants, and missingness can affect both estimates and precision. These are general considerations, not claims about what occurred in this trial.
Enrollment and completed status alone do not establish how many participants contributed to a given outcome analysis. Analysis populations, missing-data methods, and any sensitivity analyses are not reported in 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 |
|---|---|---|---|
| Active | 0 | 13 | 0.0% |
| Inactive | 0 | 11 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Active | 0 of 13 |
| Inactive | 0 of 11 |
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 |
|---|---|
| Active | 2 of 13 |
| Inactive | 6 of 11 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Active | Inactive |
|---|---|---|---|
| fatigue | General disorders | 1 of 13 | 0 of 11 |
| ear infection | Ear and labyrinth disorders | 1 of 13 | 0 of 11 |
| increased irritability | Psychiatric disorders | 0 of 13 | 1 of 11 |
| upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | 0 of 13 | 1 of 11 |
| vitamin d deficiency | Endocrine disorders | 0 of 13 | 1 of 11 |
| headahce | Nervous system disorders | 0 of 13 | 1 of 11 |
| panic attack | Psychiatric disorders | 0 of 13 | 1 of 11 |
| insomnia | General disorders | 0 of 13 | 1 of 11 |
The registry lists serious adverse events for 13 participants at risk in the active group and 11 at risk in the inactive group. It records 0 serious adverse events in each group. Deaths are recorded as 0 in both groups. For other adverse events, the record lists 2 among 13 at risk in the active group and 6 among 11 at risk in the inactive group.
These are counts in the registry record, not a complete account of each event. The registry entries available for this analysis do not provide event descriptions, onset dates, duration, severity details for the other events, or information about how events were collected. The numbers at risk for the adverse-event entries do not match the overall enrollment figure, and the record does not explain the analysis-population or follow-up basis for those counts. No reason for that difference should be inferred.
As a general statistical point, small event counts can be imprecise, and counts alone do not establish whether an observed difference is meaningful. A comparison would also need context about event definitions, follow-up, and the population assessed. The recorded zero serious events and zero deaths should be read as registry counts for the listed groups, not as proof that such events could not occur or that the groups had identical safety experience. The record does not report a formal statistical comparison of adverse events.
12. What the Result Does, and Does Not, Mean
The record establishes that a completed randomized, double-masked, parallel trial compared active and inactive Alpha-Stim devices. It identifies anxiety and depression as conditions of interest and the combined HADS score as the primary outcome. It also documents an interest in cellular-health markers, with telomere length listed as a secondary outcome. These registry entries describe the research question and the trial structure.
The record does not establish whether the active group had a higher or lower combined HADS score than the inactive group. It does not report a single primary-outcome estimate, a confidence interval, or a p-value in the registry record for this analysis. Thus, it does not establish the size, direction, or precision of a group difference. Absence of a reported comparison cannot be interpreted as evidence that the groups were the same or that a difference was absent.
Nor does the stated aim to evaluate cellular health establish that telomere length or telomerase activity changed. Telomere length is listed as a secondary outcome, while telomerase activity appears in the brief summary but is not among the listed secondary outcomes in the registry record for this analysis. Numerical results for these measures are not reported in the registry record.
The adverse-event entries report zero serious events and zero deaths in both groups, with other adverse events recorded for each. Those counts do not by themselves provide a complete comparison of safety, particularly without event detail and information about the groups assessed. They should not be expanded into a conclusion about overall risk.
As a general interpretation principle, conclusions should match the information actually reported: a defined outcome and trial design can be described even when numerical outcome results are unavailable. The registry entries support a clear account of what the investigators intended to compare, but they do not support a claim about the effectiveness of either device or a definitive conclusion about its effects.
13. Why This Trial Matters Statistically
This trial raises a useful statistical distinction between knowing what was measured and knowing what the comparison found. The registry defines a combined HADS endpoint, its score range, the meaning of higher scores, and the intended timing. It also identifies a randomized, double-masked, parallel design. Those details allow readers to understand the planned clinical question, but they are not a substitute for an estimate of the difference between groups and its uncertainty.
The record also illustrates why endpoint structure matters. A combined anxiety and depression score gives one primary measure, while the registry’s note that the primary outcome has several categories or time points leaves no single comparison in the posted summary. Without a specific contrast, estimates, or uncertainty, readers cannot assess the magnitude or precision of the primary result. This is a limitation of the available statistical reporting, not evidence about what the underlying data would show.
The distinction between an observed result and a planning illustration is also important. The stated sample-size assumptions are based on the observed effect and chosen design assumptions; they are not a report of the trial’s original enrollment rationale or observed power. Planning calculations can help explore what sample sizes might correspond to specified assumptions, but they cannot repair the absence of a reported primary comparison.
Finally, the trial’s symptom outcome and its cellular-health aims represent different kinds of measurements. The record identifies telomere length as secondary and mentions telomerase activity in its summary, but no numerical cellular results are reported in the registry record for this analysis. Keeping the outcome definitions, reported estimates, and interpretation boundaries distinct is central to reading the record accurately.
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 efficacy is that the registry record does not report a single numerical comparison for the primary HADS outcome. It gives an endpoint definition and identifies least-squares mean and standard error as the parameter and dispersion, but the group estimates, contrast, and uncertainty are not reported in the registry record for this analysis. The record itself notes that the primary outcome has several categories or time points and is not reduced to one comparison.
Details needed to understand the analysis are also not reported in the registry record. These include the model specification, analysis population, missing-data handling, treatment of multiple outcomes or time points, and any interim analyses. The registry entries available for this analysis do not describe participant characteristics, eligibility criteria, adherence, or deviations from device instructions. As a result, the enrolled population and the data contributing to each outcome cannot be characterized beyond the listed enrollment.
The brief summary names telomere length and telomerase activity as cellular-health markers of interest, while the listed secondary outcome is telomere length. Numerical findings for either measure are not reported in the registry record. This limits interpretation of the cellular-health aims and leaves unclear whether telomerase activity was analyzed as an outcome.
The safety entries include counts and numbers at risk, but not event details or an explanation of the group sizes assessed. The record therefore does not support a detailed comparison of event types or a complete characterization of safety. These limitations concern what is reported in the registry record; they do not imply what the unreported analyses or underlying data would show.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Effectiveness of CES on Emotional and Cellular Wellbeing — NCT03369418.
- Registry record last updated 2020-08-19; status last verified 2020-08.
- Results first posted 2020-08-19.
- 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
NCT03369418, titled “Effectiveness of CES on Emotional and Cellular Wellbeing,” is listed as a completed randomized, double-masked, parallel trial sponsored by the University of California, Los Angeles. The recorded enrollment is 44. The trial began in 2016-03, and its primary completion date is 2018-10-20. Its phase is listed as not applicable.
The trial compared Alpha-Stim active and inactive devices. Its primary outcome was the combined HADS score after study completion, described as one year. Telomere length is listed as a secondary outcome; the brief summary also mentions telomerase activity. The registry record does not report a single primary-outcome comparison or numerical findings for the outcomes in the registry record for this analysis.
The safety entries record 0 serious adverse events and 0 deaths in each group. Other adverse events are recorded as 2 among 13 at risk in the active group and 6 among 11 at risk in the inactive group. Further details of those events are not reported in the registry record.