rTMS Bimodal Treatment For Tinnitus: A Pilot Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for rTMS Bimodal Treatment For Tinnitus: A Pilot Study (NCT01590264), a na na study. The primary outcome is Adverse Events.

2. Clinical Question

The registry also lists change in the Tinnitus Handicap Inventory as a secondary outcome. No result for that outcome is reported. Thus, the clinical question recorded for the pilot focuses on feasibility and safety monitoring, while the potential change in tinnitus handicap is listed without a posted estimate. The small single-group design is descriptive and cannot establish how outcomes would compare under a different condition.

3. Trial Design

This completed study is registered as a pilot of bimodal repetitive transcranial magnetic stimulation for tinnitus. It is classified as a single-group study, with enrollment of 5 participants. The phase is listed as not applicable. Allocation is not reported as a randomized process, and masking is listed as none. The summary describes the investigation as open-label and as a feasibility pilot. No parallel control arm is recorded.

The intervention is named Bimodal rTMS and classified as a device intervention. Its description specifies placement of the magnet over the DLPFC and TPJ for 2 weeks of treatment, scheduled across 10 days. The study summary instead refers to the left DLPFC and left TPC. These are the terms used in the registry descriptions; additional treatment details beyond the listed settings and locations are not reported in the registry record.

The primary outcome is Adverse Events, measured as participants and queried daily for 2 weeks. The registry describes the outcome as a foremost feasibility measure and says the relation of adverse events to treatment is primary. The listed secondary outcome is change in the Tinnitus Handicap Inventory. Although the record lists 2 outcome measures, it records no analyses. Outcome results for the secondary measure, methods for assessing it, and the timing or scoring details beyond its stated change are not reported in the registry record.

The registry records the study as completed and gives the study start as 2012-05 and primary completion as 2012-09. It identifies Washington University School of Medicine as sponsor. These administrative details do not supply a statistical analysis plan: the planned analysis methods, sample-size justification, interim analyses, and definition of analysis populations are not reported in the registry record. Because there is no control group, the design can describe observations in the treated group but cannot provide a controlled estimate of the intervention’s effect.

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.

Before assignment: Subjects were enrolled for one pre-treatments screening visits, received two weeks of rTMS treatment, and were assessed at the last treatment day. There was no additional follow-up.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Pilot study based on convenience sample.

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.

6. Primary Endpoint

The registry lists the primary outcome as Adverse Events, measured over Daily for 2 weeks..

The primary endpoint is the number of participants with adverse events. The registry says participants were to be queried daily during 2 weeks of treatment. It identifies adverse events, and their relation to treatment, as the primary measure because the study was intended as a feasibility pilot. This endpoint therefore concerns recorded safety events during the treatment period, rather than a comparative measure of tinnitus improvement.

A participant count is a straightforward descriptive way to report whether any enrolled participants had an event recorded. It is not the same as a count of every event: a participant may experience more than one event, but the posted measure is defined in participants. The registry does not provide event descriptions, severity grading criteria, causality assessment procedures, or detail on how missing daily queries would be handled. Those details are not reported in the registry record.

The adverse-event counts record 0 participants affected among 5 at risk in both the serious-event and other-event categories. These are the posted counts, not evidence that every scheduled query was completed or that no unrecorded event occurred. The registry does not report follow-up completeness or an uncertainty interval around these counts.

Change in the Tinnitus Handicap Inventory is listed as a secondary outcome, but no result or analysis is recorded. Consequently, the registry record does not provide a numerical estimate of change in tinnitus handicap. The endpoint information supports a descriptive account of the recorded event counts and the intended feasibility focus, but not an estimate of comparative benefit or a conclusion about the frequency of events beyond the posted observations.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The available statistical information is primarily descriptive. The record identifies a single-group study with 5 enrolled participants and lists participant counts at risk and affected for adverse events. It records 2 outcome measures and 0 analyses. No statistical analysis plan is reported in the registry record, so the intended inferential methods, model specifications, and decision criteria cannot be reconstructed.

What does a participant count describe?

The primary measure is expressed in participants, and the registry’s definition of the event outcome is participants with an event. A participant count indicates how many people were recorded as affected in the relevant category. It is not a count of all event episodes, and it does not convey how long each participant was observed beyond the stated daily queries during 2 weeks of treatment. The posted count is 0 affected among 5 at risk for serious events, and 0 affected among 5 at risk for other events.

General statistical explanation: descriptive counts are often useful for a feasibility study because they communicate what was observed without implying a comparison or a causal effect. A denominator gives context for a count. However, a count alone does not explain whether all participants completed all assessments, how events were defined, whether multiple events per participant were possible, or how event severity and relatedness were judged. Those procedures are not reported in the registry record.

Why does a confidence interval matter?

General statistical explanation: a confidence interval communicates the uncertainty associated with an estimate. For a participant proportion, it can show how imprecise an observed event frequency may be, especially when the sample is limited. The registry does not report a confidence interval or another uncertainty measure for the adverse-event counts. No interval should be inferred from the counts in the record.

Even if a count is zero, that observation does not establish that the underlying rate is zero. The result means no affected participants were recorded in the relevant category among those at risk in this study. It does not quantify the range of plausible rates in a wider population. The uncertainty is especially relevant when a pilot is small, but a numerical uncertainty statement cannot be made without a reported analysis.

What can the design estimate?

The single-group design is suited to describing what was observed in the group receiving Bimodal rTMS, but it does not provide a concurrent control condition. General statistical explanation: a controlled comparison helps distinguish differences associated with an intervention from background change, other exposures, or measurement effects. Without a comparator, a before-and-after change, if it had been reported, would not by itself identify the intervention as its cause. Here, no Tinnitus Handicap Inventory change result is reported either.

The record states that masking was none and describes the study as open-label. No allocation procedure is reported. These design features should be kept in mind when interpreting subjective assessments or event reporting. The registry does not describe blinded outcome assessment, independent event adjudication, or any adjustment for possible sources of bias.

What is missing from the analysis record?

The registry does not report analysis populations, missing-data methods, statistical tests, effect estimates, or multiplicity procedures. It also does not report interim analyses or a sample-size justification. Without these details, it is not possible to determine whether all enrolled participants were included in every outcome assessment, how incomplete records were handled, or whether analyses were prespecified.

The registry’s sample-size assumptions refer to an illustration for two arms, with equal allocation, a two-sided significance level of 0.05, and a normal approximation. The effect to detect is described as a fraction of the observed effect. This is a planning framework, not the actual single-group design. The assumptions do not establish that the pilot was designed or powered for a two-arm comparison, and the computed planning values are not reported in the record. Such planning illustrations are not observed power and should not be mistaken for the results of this pilot.

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("Bimodal rTMS")
n      <- c(5)
events <- c(0)
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  Bimodal rTMS  5  0  0.0  0.0  52.2  0.0  43.4  0.4  45.9

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 2 outcome measures: adverse events as the primary outcome and change in the Tinnitus Handicap Inventory as a secondary outcome. It records 0 analyses. No multiplicity procedure, hierarchy beyond the primary and secondary labels, or prespecified approach to interpreting multiple outcomes is reported in the registry record. As a result, no adjustment or testing strategy can be attributed to the study.

The registry does not report how missing observations were handled. Although adverse events were intended to be queried daily for 2 weeks, the record does not state whether all planned queries were completed, how many observations were missing, or whether participants discontinued follow-up. The completeness of the daily safety assessments is therefore not reported in the registry record. The secondary outcome’s assessment schedule and missing-data handling are also not reported.

Analysis populations are not described. The registry does not say whether analyses were intended to include all enrolled participants, only those who completed treatment, or another defined group. With no analyses posted, there is no population-specific result to interpret.

General statistical explanation: multiplicity arises when several outcomes or statistical tests are considered, because repeated opportunities to identify a finding can affect the interpretation of nominal significance levels. Missing-data methods matter because incomplete observations can affect both estimates and their uncertainty. These are general considerations, not claims about procedures used in this pilot. The record does not report the methods needed to assess either issue.

12. Safety Results

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

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

The adverse-event record reports 0 participants affected by serious adverse events among 5 at risk. It also reports 0 participants affected by other adverse events among 5 at risk. These are participant counts, not counts of the total number of event episodes. The death count is not reported in the registry record.

The study description says participants were to be queried for adverse events daily for 2 weeks of treatment. This describes the intended monitoring schedule; it does not establish that every query was completed. The registry does not report monitoring completeness, event definitions, severity criteria, relatedness assessments, or individual event details. Accordingly, the zero affected counts should be read as the recorded results, not as proof that no event occurred or that the event risk is absent.

General statistical explanation: safety counts from a small group are descriptive and are most informative when interpreted with their denominator, duration of observation, and completeness of reporting. No confidence interval or other uncertainty estimate is reported. The counts alone cannot indicate how precisely event frequency is known beyond the participants recorded in this study.

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

The registry record documents a feasibility pilot of open-label Bimodal rTMS in a single group of 5 participants. Its primary outcome was adverse events, with daily queries planned during 2 weeks of treatment. The posted adverse-event counts are 0 participants with serious events and 0 with other events among 5 at risk in each category. These observations describe the recorded safety data for this group.

The record does not report an analysis of adverse events, uncertainty intervals, or details about completion of monitoring. It also does not report a death count. For that reason, the observed zero counts should not be interpreted as proof that the intervention has no safety risks. They do not estimate event frequency precisely for people outside the study.

The study has no separate comparator and is listed as unmasked. It therefore cannot provide a controlled estimate of how outcomes differ from another treatment or from no intervention. The record lists change in the Tinnitus Handicap Inventory as a secondary outcome but does not report a result. It consequently does not establish whether participants’ tinnitus handicap changed during the study.

The findings are also limited by absent statistical and operational details. Analysis populations, missing-data handling, multiplicity procedures, sample-size justification, and interim analyses are not reported in the registry record. These omissions prevent a fuller assessment of how outcomes were analyzed and how complete the observations were.

The appropriate reading is narrow: the registry records a completed feasibility pilot, a planned daily safety-query schedule, and zero participants affected in the two posted adverse-event categories. It does not provide evidence from a controlled comparison or a reported estimate of change in tinnitus symptoms. General statistical interpretation: descriptive pilot findings can inform what was observed and what questions a later study might address, but they do not substitute for a controlled effect estimate.

14. Why This Trial Matters Statistically

This trial is statistically informative because it makes the distinction between feasibility monitoring and comparative treatment evaluation visible. The registry identifies adverse events as the primary outcome and describes daily querying during treatment. That focus is consistent with a pilot whose stated purpose is feasibility, rather than a controlled comparison of clinical outcomes.

The design is single-group and open-label, with enrollment of 5 participants. This means the posted counts answer a limited descriptive question: how many participants in this group were recorded as affected by each adverse-event category? The record reports zero affected participants in both categories. It cannot answer how those counts would compare with a control group, because no control group is recorded.

The registry also illustrates why an outcome being listed is not the same as an outcome being analyzed. Change in the Tinnitus Handicap Inventory appears as a secondary outcome, but no result is reported, and the record lists 0 analyses. Readers therefore cannot assess a numerical change, its precision, or its statistical interpretation from the registry record.

General statistical explanation: a well-defined denominator, an explicit endpoint, and transparent analysis methods are essential for judging what a study’s results mean. The adverse-event denominator is recorded, but follow-up completeness and uncertainty estimates are not. The analysis populations, missing-data handling, multiplicity approach, and sample-size justification are also not reported. These gaps limit the conclusions that can be drawn even from the simple event counts.

The record’s planning assumptions describe a hypothetical two-arm illustration, while the actual study is single-group. Keeping those distinct is important: planning assumptions do not turn a single-group pilot into a comparative trial, and planning calculations are not evidence of an observed treatment effect. The study matters statistically as a clear example of how design, endpoint, and reporting determine the scope of valid interpretation.

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 most direct limitation is the single-group design. With no comparator, the registry cannot support a like-for-like treatment comparison. The study is also open-label, with masking listed as none. These design characteristics limit causal interpretation, particularly for subjective outcomes and event reporting.

The record reports enrollment of 5 participants and describes the sample as a convenience sample. It does not report additional participant characteristics or eligibility details. Generalizability to other groups cannot be assessed from the registry information alone.

Although adverse events were to be queried daily for 2 weeks, completion of those queries is not reported. The registry gives zero affected participants in each adverse-event category but does not provide event definitions, severity grading, relatedness assessments, or the death count. The completeness and detail of safety ascertainment therefore cannot be evaluated fully.

The secondary outcome, change in the Tinnitus Handicap Inventory, is listed without a result. No analyses are recorded. Statistical methods, analysis populations, missing-data handling, multiplicity procedures, interim analyses, and sample-size justification are not reported in the registry record. There are no reported uncertainty estimates for the adverse-event counts.

The treatment description refers to the DLPFC and TPJ, while the study summary refers to the DLPFC and TPC. The registry does not clarify the difference in terminology. It states a 2-week treatment period over 10 days, but further implementation and adherence details are not reported. Together, these limits mean the record supports only a narrow descriptive account of the registered design and posted safety counts, not a comprehensive evaluation of treatment effects or safety.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: rTMS Bimodal Treatment For Tinnitus: A Pilot Study — NCT01590264.
• Registry record last updated 2013-04-02; status last verified 2012-09.
• Results first posted 2013-04-02.
• 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.

19. Record Summary

The registry identifies NCT01590264 as a completed, single-group, open-label feasibility pilot sponsored by Washington University School of Medicine. It records enrollment of 5 participants and an intervention named Bimodal rTMS. The treatment description specifies stimulation over the DLPFC and TPJ for 2 weeks across 10 days; the summary refers to the DLPFC and TPC.

Adverse events were the primary outcome, with daily queries planned during treatment. The registry reports 0 participants affected by serious adverse events and 0 affected by other adverse events, among 5 at risk in each category. The death count is not reported. Change in the Tinnitus Handicap Inventory is listed as a secondary outcome, but no result is reported. The record lists 2 outcome measures and 0 analyses.

No comparator is recorded. Analysis methods, missing-data procedures, analysis populations, multiplicity handling, interim analyses, and sample-size justification are not reported in the registry record. The available evidence is therefore descriptive and limited to the posted study details and adverse-event counts.