Examining the Effectiveness of Deep TMS in Veterans With Alcohol Use Disorder: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Examining the Effectiveness of Deep TMS in Veterans With Alcohol Use Disorder (NCT04927364), a na na study. The primary outcome is Number of Participants With Relapse to Alcohol 6 Months After Treatment.

2. Clinical Question

3. Trial Design

This was a completed, single-group study sponsored by VA Palo Alto Health Care System. The registry lists enrollment of 8 and describes the study as examining deep transcranial magnetic stimulation in Veterans with alcohol use disorder. Phase is listed as NA. Allocation is also listed as NA, and masking is listed as none. The record does not describe a randomized assignment process or a control group, so the study is not a like-for-like treatment comparison.

The intervention was the Deep Transcranial Magnetic Stimulation H7 coil. The arm description says participants would receive 30 treatments, 3 times per day over 10 consecutive business days, with each treatment visit lasting approximately 30 minutes in total. This is the described schedule; the record does not report how many participants received every scheduled treatment or how many completed the treatment course.

The study start date is 2022-09-06, and the primary completion date is 2023-11-17. The registry status is completed. Those dates and status describe the study record, but do not establish that every planned assessment was obtained or that results were analyzed. The registry lists 3 outcome measures and 0 analyses. The primary outcome concerns relapse status 6 months after treatment, for participants who completed at least half of treatment sessions. The record does not report the size or characteristics of that outcome population. Without a control group, any observed outcome would be descriptive of participants in this study rather than an estimate of the difference caused by dTMS relative to another condition.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Participants who completed at least half of the treatment sessions.

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: Participants who received TMS.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With Relapse to Alcohol 6 Months After Treatment, measured over 6 months.

The primary endpoint is the number of participants with relapse to alcohol 6 months after treatment. It is a binary outcome at the participant level: each assessed participant is classified by whether self-reported relapse occurred, and the endpoint is expressed as a count of participants with the event. The registry specifies that the relevant population consists of participants who completed at least half of the treatment sessions.

Relapse status was to be determined by contacting participants and using the Alcohol Timeline Followback and Brief Addiction Monitor questionnaires. These instruments are described as brief standardized measures of alcohol and substance use. The stated approach makes the endpoint a follow-up assessment based on participants' reports rather than a measure of treatment attendance or an objective biological measure.

A relapse count can describe how many assessed participants met the endpoint definition. To interpret that count as a proportion or rate, the number of participants whose status was assessed would also be needed. The registry record does not report either the primary event count or the assessed denominator. It also does not report a definition of relapse beyond the description of self-reported status and the named measures. Thus, the endpoint's intended meaning is clear at a broad level, but the posted record does not permit estimation of its observed frequency or precision.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a count of participants classified as having experienced relapse, which makes it a binary participant-level endpoint summarized as a count. The registry describes follow-up at 6 months after treatment and an assessment population defined by completion of at least half of treatment sessions. This definition is important because the enrolled population, the population that began treatment, the population that met the completion condition, and the population with observed follow-up may differ. The registry record does not report those participant counts or how missing follow-up was handled.

What does a binary count describe?

A binary outcome assigns each assessed participant to an event or no-event category under the stated endpoint definition. A count of events is easy to understand, but its meaning depends on the number of participants whose outcome status is known. The same event count can represent different underlying frequencies when denominators differ. A proportion would require both the event count and the assessed denominator; neither is reported for the primary endpoint in this record. It would therefore be inappropriate to calculate a percentage or infer that enrollment equals the analysis population.

For binary outcomes, uncertainty can generally be expressed with a confidence interval around an event proportion. A confidence interval describes the range of values reasonably compatible with the observed data under the specified statistical method. It is not a guarantee that the true value lies within a particular interval, and its width depends on the amount and pattern of information available. Since the registry does not report the primary event count, denominator, or interval, no outcome precision can be assessed from the posted record.

Why does the study structure matter?

The registry identifies a single-group design, with no masking and no like-for-like control comparison. A single-group description can support an account of what happened among the observed participants, if outcome data are reported. It cannot, on its own, separate an intervention effect from other possible explanations for an outcome. In a comparative trial, a between-group contrast can help address that question, subject to its design and analysis assumptions. No such contrast is available in this record.

Masking is listed as none. In general, masking can reduce the influence of knowledge about treatment assignment on outcome assessment or participant reporting, depending on who is masked and how outcomes are measured. The endpoint relies on self-reported status gathered using named questionnaires. The record does not describe additional procedures intended to reduce reporting or assessment influences. These general methodological points do not establish that any particular bias occurred.

How should the planning assumptions be read?

The planning note describes an illustration using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a stated fraction of the observed effect. It also distinguishes participant-per-arm planning from event totals for time-to-event settings. Those are planning conventions, not a report of the study's actual design: the registered study is single-group, and no two-arm allocation is described. The note explicitly characterizes the calculations as planning illustrations rather than the trial's own design.

Planning calculations answer a conditional question: under specified assumptions, what amount of information might be needed to detect a chosen effect with a chosen statistical procedure? They do not show that an effect was observed, that the planned information was obtained, or that a study had a particular probability of success after completion. Sample-size illustrations are not observed power. The registry record does not report the trial's own sample-size justification, and it does not report the primary outcome values needed to assess an observed effect from the registry entry.

In general, a normal approximation is a mathematical shortcut whose suitability depends on the data and assumptions. For binary outcomes with limited information, approximate methods can behave differently from methods designed for sparse counts. The record does not report an analysis method for the primary endpoint, so no particular estimator, test, or interval procedure can be attributed to this study. No recalculated estimate can replace the sponsor's analysis; if a recalculation differs from a sponsor analysis, the sponsor's own analysis takes precedence. The registry lists no analyses, so a sponsor analysis is not posted in this record.

What would be needed for an informative estimate?

At a minimum, interpretation of the planned endpoint would require the number of participants assessed at follow-up, the number meeting the relapse definition, and a clear account of how participants without an observed status were treated. A confidence interval could then convey statistical uncertainty around an estimate, subject to an appropriate method. An analysis plan would clarify whether the primary result was intended to be descriptive or tested against a prespecified value, and how any other outcomes were to be handled. These details are not reported in the registry record. The absence of a posted analysis means readers cannot determine whether a model, adjustment, or formal hypothesis test was used.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Active dTMS")
n      <- c(5)
events <- c(3)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Active dTMS  5  3  60.0  14.7  94.7  23.1  88.2  22.3  88.2

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 3 outcome measures and 0 analyses. The primary outcome is identified as relapse status 6 months after treatment, but the registry record does not report how the other outcomes were prioritized in statistical testing, whether a formal testing hierarchy was prespecified, or whether any adjustment for multiple comparisons was planned. When several outcomes or statistical tests are considered, the chance of at least one apparently notable finding can rise if each is interpreted separately. Methods such as a prespecified hierarchy or multiplicity adjustment can address that concern, but no method can be attributed to this study from the record.

The endpoint description defines an outcome population of participants who completed at least half of treatment sessions. The record does not report how many participants met that criterion, how many were contacted, how many posted usable responses, or whether any outcome information was missing. It does not describe imputation, sensitivity analyses for missing data, or assumptions about participants without follow-up. Consequently, the extent to which missing status could affect the reported endpoint cannot be assessed.

The registry does not describe an intention-to-treat population, a per-protocol population, or another analysis population for the primary endpoint. The stated treatment-completion condition is not enough to establish which participants were included in an analysis, particularly because no analysis is posted. The number enrolled should not be treated as the denominator for the primary result without a reported analysis population and outcome data.

These omissions limit assessment of selective reporting, missing-data handling, and the relationship between planned and reported analyses. They do not establish that such practices were inappropriate; they mean the relevant methods are not reported in the registry record.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry's adverse-event figures for Active dTMS list 0 serious adverse events among 8 participants at risk and 0 deaths among 8 at risk. The record also lists 0 other adverse events among 8 at risk. No serious adverse-event terms are listed. These are counts in the registry record and should be read as the posted safety information, rather than as proof that no adverse event of any kind occurred.

In general, an event count is more informative when the reporting period, event definitions, ascertainment procedures, and completeness of reporting are clear. The record does not provide further detail about those matters in the registry record for this analysis. It also does not describe a comparison group, so these figures cannot estimate a relative safety difference between dTMS and another condition. A count of zero in a small single-group study can be compatible with uncertainty about the frequency of uncommon events; it does not establish that the underlying risk is zero. No rate or confidence interval should be inferred from the posted counts.

13. What the Result Does, and Does Not, Mean

The registry record documents a completed single-group study of deep transcranial magnetic stimulation in Veterans with alcohol use disorder, including a planned assessment of self-reported relapse 6 months after treatment. It also records adverse-event counts for the Active dTMS group. Those design and reporting details can help readers understand what the study intended to examine and what safety figures were entered.

The posted record does not establish the observed primary relapse result. It gives no event count or assessed denominator, and it lists 0 analyses. Therefore, it does not support a numerical estimate of relapse frequency, a confidence interval describing its precision, or a statistical test of the primary endpoint. The enrollment figure is not sufficient to fill in these missing outcome data, particularly because the endpoint population depends on treatment-session completion and follow-up status.

The single-group design also limits causal interpretation. Even if a before-and-after or follow-up outcome were posted, an outcome within the treated group would not by itself show what would have happened under a different condition. The record does not contain a randomized comparison or control group that would support a direct treatment contrast. This limitation concerns the design's ability to identify causation, not whether participants experienced any particular outcome.

The safety counts are descriptive and should not be generalized beyond what the registry records. Zero reported events in a study of this size does not prove absence of risk, and the lack of a comparator prevents a comparative safety estimate. The appropriate statistical reading is therefore restrained: the record describes the study and reports zero listed adverse-event counts, but it does not post primary efficacy results or an analysis from which treatment effects can be estimated.

14. Why This Trial Matters Statistically

This study illustrates the difference between a registered research question and a reported statistical result. The registry specifies a clinically relevant follow-up endpoint, the assessment approach, and a treatment-completion condition for the endpoint population. Those details clarify what the investigators intended to measure. Yet a clearly defined outcome does not become interpretable evidence of an observed result unless the event count, denominator, and analysis are also reported.

It also illustrates why design determines the scope of a statistical conclusion. A single-group study can describe outcomes among participants who were assessed, but it does not provide a contemporaneous control contrast. That distinction matters when readers are tempted to treat a post-treatment outcome as an estimate of what the intervention caused. Statistical precision and causal identification are separate issues: a precise estimate within one group would still not provide a randomized between-group comparison.

The record highlights the importance of defining the analysis population. The primary endpoint applies to participants who completed at least half of treatment sessions, rather than automatically to everyone enrolled. Without reporting how many participants met that criterion and how many had follow-up data, readers cannot determine the denominator or assess missingness. The enrollment figure alone cannot answer those questions.

Finally, the posted safety counts show why zero observed events need careful interpretation. Such counts are useful descriptive information, but they do not demonstrate that risk is absent or establish a comparison. Together, these features make the registry record statistically informative about the intended design and reporting gaps, while leaving the primary outcome's observed frequency and precision unresolved.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The main limitation for interpreting this specific record is that it does not report the primary endpoint result or any analysis. The relapse count, the number assessed at 6 months, and an estimate of uncertainty are not reported in the registry record. The study's enrollment of 8 cannot stand in for the endpoint denominator because the primary outcome population is restricted by treatment completion and may also depend on follow-up availability.

The single-group design has no reported control condition, and allocation is listed as NA. This prevents a direct comparison with another group and limits what can be inferred about whether any observed outcome was attributable to dTMS. Masking is listed as none, while the primary endpoint depends on self-reported measures. The record does not give further details about outcome ascertainment or procedures to address potential reporting influences.

The record does not report how many participants completed treatment, how many completed at least half of sessions, or how many provided follow-up data. It also does not report a missing-data method, an analysis population, or sensitivity analyses. The treatment schedule is described, but the record does not establish actual adherence to the schedule for each participant.

Although 3 outcome measures are listed, the registry does not report an analysis plan or a method for handling multiple outcomes. It lists 0 analyses. The sample-size justification for the trial itself is not reported in the registry record; planning illustrations should not be mistaken for the original design rationale or for evidence of observed power. These limitations leave both the primary outcome and its statistical precision undetermined in the posted record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Examining the Effectiveness of Deep TMS in Veterans With Alcohol Use Disorder — NCT04927364.
• Registry record last updated 2025-12-29; status last verified 2025-12.
• Results first posted 2024-07-10.
• 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.

19. Record Summary

NCT04927364 is a completed, single-group study sponsored by VA Palo Alto Health Care System, with enrollment of 8. It examined deep transcranial magnetic stimulation using an H7 coil in Veterans with alcohol use disorder. The described schedule was 30 treatments, 3 times per day over 10 consecutive business days, with each visit lasting approximately 30 minutes.

The primary outcome was the number of participants with self-reported relapse 6 months after treatment among those completing at least half of treatment sessions. The record lists 3 outcome measures and 0 analyses, but does not report the primary event count, denominator, or an outcome estimate. The adverse-event record lists 0 serious adverse events, 0 other adverse events, and 0 deaths among 8 at risk. No control group is described, so these safety counts are not comparative estimates.