Niche Trial: Navigated Inhibitory rTMS to Contralesional Hemisphere Trial: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Niche Trial: Navigated Inhibitory rTMS to Contralesional Hemisphere Trial (NCT02089464), a randomized na study. The primary outcome is Upper Extremity Fugl-Meyer Score.

2. Clinical Question

3. Trial Design

The registry describes NCT02089464, the Niche Trial, as a pivotal, prospective, multicenter, randomized, double-blind, sham-controlled study. Its official title describes a Phase III trial, while the phase field is recorded as NA. The recorded status is completed. The record lists enrollment of 199 and dates of 2014-04 for study start and 2016-05 for primary completion.

The design is parallel-group, with triple masking recorded in the registry. The two groups received either NBS-guided rTMS plus task-oriented rehabilitation or sham rTMS plus task-oriented rehabilitation. The active treatment targeted the contralesional hemisphere and was described as 1 Hz rTMS. The study summary says treatment was delivered for 6 weeks, and the primary outcome was assessed 6 months after treatment.

The primary outcome results are listed for the intent-to-treat population. The posted group counts for this outcome are 132 in the active-rTMS group and 67 in the sham-rTMS group. Those counts are the denominators attached to the outcome data; the record does not explain any difference between those denominators and the enrollment entry.

The record names secondary measures spanning arm function, motor function, stroke severity, stroke impact, mood, and quality of life. It reports numerical results for the Arm-Research Action Test, Wolf Motor Function Test, and NIH Stroke Scale in the posted comparisons. Further details about allocation concealment, the original analysis plan, and the trial's sample-size justification 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

Analysis population for the primary outcome, as defined in the registry: Intent to treat

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 Upper Extremity Fugl-Meyer Score, measured over Baseline - 6 months post-treatment.

The primary endpoint is a count of participants whose Upper Extremity Fugl-Meyer Score improved by at least the stated Minimal Clinically Important Difference of 5 points at 6 months post-treatment. The registry gives the timeframe as Baseline - 6 months post-treatment and identifies the population as intent to treat. In practical terms, this endpoint turns a change on a motor-function scale into a yes-or-no outcome: whether each participant reached the prespecified threshold.

A threshold-based outcome can make a result easier to relate to a change regarded as clinically meaningful, rather than focusing only on an average score change. It also discards information about how far above or below the threshold each participant's change fell. Two participants with different score changes can count identically if both meet the threshold, while a change just short of the cutoff is classified differently from one that reaches it. The primary result therefore answers a specific question about the proportion reaching the cutoff; it is not a complete account of all changes in upper-extremity function.

The threshold is part of the endpoint definition in the registry. The record does not provide further detail about how that threshold was selected or about the distribution of individual score changes. The posted result should be read as a comparison of threshold attainment between the randomized groups, not as a comparison of mean UEFM scores.

7. Results Posted in the Registry

• NBS-rTMS + Task-oriented Rehabilitation: 66.7% (88/132) versus 64.2% (43/67) on control; risk difference 2.5 percentage points (95% CI -11.5 to 16.5), risk ratio 1.04 (0.84–1.29); unadjusted two-proportion z-test p = 0.727.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Arm-Research Action Test (ARAT)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • NBS-rTMS + Task-oriented Rehabilitation: mean 5.00 versus 5.00 on control; difference 0.00 (95% CI -2.92 to 2.92), standardized effect d = 0.00; z-test p = 1.000.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between NBS-rTMS + Task-oriented Rehabilitation and the control. The interval gives the range of effects that remain compatible with the data.

Wolf Motor Function Test

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • NBS-rTMS + Task-oriented Rehabilitation: mean -9.00 versus -10.60 on control; difference 1.60 (95% CI -8.49 to 11.69), standardized effect d = 0.05; z-test p = 0.756.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between NBS-rTMS + Task-oriented Rehabilitation and the control. The interval gives the range of effects that remain compatible with the data.

NIH Stroke Scale (NIHSS)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • NBS-rTMS + Task-oriented Rehabilitation: mean -0.40 versus -0.70 on control; difference 0.30 (95% CI -0.06 to 0.66), standardized effect d = 0.24; z-test p = 0.105.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between NBS-rTMS + Task-oriented Rehabilitation and the control. The interval gives the range of effects that remain compatible with the data.

The registry lists secondary measures covering arm activity, motor-task performance, stroke severity, stroke impact, mood, and quality of life. The numerical summaries available in the posted comparisons include ARAT, WMFT, and NIHSS. Across these measures, the overall pattern does not provide a consistent, clear separation between the randomized groups. The secondary results therefore do not materially change the interpretation of the primary threshold-based comparison.

Secondary outcomes can help describe whether a pattern appears across different domains, but they are not interchangeable. A scale score, a task-completion time, and a stroke severity measure represent different aspects of health and use different units. An apparent pattern across them needs to be interpreted with attention to outcome definitions, analysis methods, and the direction in which each scale changes. The registry record does not establish that the listed measures were designed as a single combined test of treatment effect.

Multiplicity matters because testing several outcomes creates more opportunities for chance findings. Unless a prespecified strategy accounts for that, an unadjusted secondary p-value has less evidential weight than a single primary test. The registry record does not report a multiplicity adjustment or a hierarchy for the secondary analyses. The secondary outcomes are best treated as supportive context, not as independent confirmation or grounds for overriding the primary result.

The range of named outcomes is informative about what the study sought to assess, but the registry summaries do not provide a basis to infer results for every domain or to generalize beyond the reported measures and assessment timeframe. Numerical results for outcomes not included in the posted comparisons are not reported in the registry record.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Arm-Research Action Test (ARAT)
• Wolf Motor Function Test
• NIH Stroke Scale (NIHSS)
• Chedoke-McMaster Stroke Assessment (CMSA)
• Stroke Impact Scale (SIS)
• Patient Health Questionnaire (PHQ9)
• Quality of Life Assessment: EuroQol EQ-5D Scale

9. Statistical Interpretation

10. Statistical Methods Explained

What is the primary effect measure?

The primary outcome is binary: each participant either reached the UEFM improvement threshold or did not. A risk is the proportion with the event in a group. The posted proportions are 0.667 for NBS-rTMS plus rehabilitation and 0.642 for sham rTMS plus rehabilitation. A risk difference subtracts the comparator risk from the active-group risk, so zero represents equal observed proportions. The recalculated risk difference is 0.025. Its interval, -0.115 to 0.165, describes uncertainty around that unadjusted estimate.

Other relative measures can express the same binary comparison in different ways. The recalculated risk ratio is 1.039, with an interval of 0.837 to 1.289; the recalculated odds ratio is 1.116, with an interval of 0.603 to 2.068. A risk ratio compares the risks directly, while an odds ratio compares the odds of the event. These are different scales of effect, not separate outcomes. The reported registry analysis is a chi-squared test and gives p = 0.76; the recalculated unadjusted p-value is 0.727.

What does a confidence interval convey?

In general, a confidence interval represents the uncertainty in an estimate under the method used to construct it. A narrow interval indicates that the estimate is more precisely localized; a broad interval leaves more plausible values compatible with the data and method. For a risk difference, an interval that includes zero does not establish a direction of difference. It also does not prove that the true difference is zero. The registry does not report the confidence level for its own analysis; the listed intervals accompany the unadjusted recalculations.

How are continuous outcomes handled?

The posted secondary measures include mean changes and standard deviations for ARAT, WMFT, and NIHSS. A mean describes the central value of the group results, while a standard deviation describes the spread of participant measurements around that mean. A mean difference compares group means. The recalculated mean-difference intervals for the listed comparisons cross zero, so those calculations do not establish a clear difference in either direction. The sponsor-reported tests use methods that vary by outcome: two-sided t-tests are listed for ARAT and NIHSS, and a Wilcoxon (Mann-Whitney) test is listed for WMFT.

Methods can target different features of the data. A t-test compares means under its assumptions; a rank-based test compares distributions through the ordering of observations and does not require the same modeling assumptions. The registry does not report enough detail to assess all implementation choices, such as transformations, covariate adjustment, or handling of unusual observations.

Why can over-dispersion matter?

In general, over-dispersion means that observed variability is greater than a statistical model expects. When that happens, standard errors based on the narrower model may be too small, making intervals look too tight and tests more decisive than warranted. The primary endpoint is a participant count, and the record does not report an over-dispersion model or a protocol-defined adjustment for it. The simple recalculation uses the posted summary counts and should be understood as unadjusted, not as a reconstruction of any unreported model.

What should be inferred from a p-value?

A p-value describes how unusual results at least as incompatible with a specified null hypothesis would be if that null and the test assumptions held. It is not the probability that the null hypothesis is true, nor a measure of the clinical importance of the estimate. The reported p-value and the effect estimate with its interval answer related but different questions. The primary p-values do not indicate a statistically clear departure from equal group risks under their respective analyses; they do not establish equality or rule out potentially meaningful differences.

11. Confidence Intervals and Precision

The recalculated primary risk difference is 0.025, with an interval from -0.115 to 0.165. Because the interval includes zero, the data do not precisely determine whether the observed difference reflects a higher or lower threshold-attainment proportion in the active-rTMS group. The range also extends meaningfully on both sides of zero, so the estimate should not be read as proving that any possible difference is negligible.

Precision is about how tightly the data locate an effect, not just whether a test crosses a significance threshold. The registry reports 88 threshold achievers among 132 in the active group and 43 among 67 in the sham group. Those observed counts support the estimated comparison, while the interval reflects uncertainty in estimating the underlying group difference from these data. A p-value alone would not communicate the possible magnitude of the difference as directly.

The recalculated intervals for the risk ratio and odds ratio also span their respective null values: 1.039 with interval 0.837 to 1.289 for the risk ratio, and 1.116 with interval 0.603 to 2.068 for the odds ratio. The null value for these relative measures is 1, unlike the null value of zero for a difference. The multiple effect scales are consistent with uncertainty about the direction and magnitude of the primary comparison.

The posted summaries do not include the confidence level used for these recalculated intervals, nor a confidence interval from the sponsor's reported primary test. The sponsor's chi-squared analysis reports p = 0.76. That p-value and the recalculated intervals come from different presentations of the evidence; the registry record does not give enough detail to attribute their small numerical differences to a specific calculation choice.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size illustrations express the required number of participants per arm, not total events. The primary endpoint and the listed continuous outcomes are not time-to-event outcomes; the note about total events applies to time-to-event tables using the Schoenfeld method. The registry record does not report the original trial's sample-size justification or its planning assumptions, so the illustrations should not be mistaken for the trial's original design calculation.

The planning assumptions listed for these illustrations are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set to a stated fraction of the observed effect. For the primary endpoint, the illustration based on 100% of the observed effect gives 5,738 participants per arm for 80% power and 7,681 participants per arm for 90% power. Planning for 75% of the observed effect gives 10,244 participants per arm for 80% power and 13,713 participants per arm for 90% power. Planning for 50% of the observed effect gives 23,145 participants per arm for 80% power and 30,983 participants per arm for 90% power.

In plain language, the 80% column gives the modeled group size for a design with an 80% chance of detecting the specified effect under the stated assumptions if that effect is real. The 90% column applies a higher chance-of-detection target and therefore calls for more participants in these illustrations. Smaller effects are harder to distinguish from random variation and require more participants. These figures are planning illustrations, not observed power; they are based on the observed effect and do not establish what the original trial was designed to detect.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.642; treatment proportion p₁ = 0.667; average p̄ = 0.654.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.6726 = 1.3183.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.6724 = 0.5659.
4. n = (1.3183 + 0.5659)² / (0.0249)² = 5,737.5, rounded up to 5,738 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
p0 <- 0.641791044776119                          # control proportion
p1 <- 0.666666666666667                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(2089464)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 5,738 (80% power), 7,681 (90% power)
 75% of observed effect: n per arm = 10,244 (80% power), 13,713 (90% power)
 50% of observed effect: n per arm = 23,145 (80% power), 30,983 (90% power)
power.prop.test: 5737.5 
Simulated power at n = 5,738 per arm: 0.802 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The registry's primary analysis is a chi-squared superiority test comparing the randomized groups. It reports p = 0.76 and does not include an effect estimate or interval in the reported analysis entry. The recalculation uses the posted participant counts and produces an unadjusted risk difference of 0.025, with an interval from -0.115 to 0.165 and p = 0.727.

The recalculation is a supplementary, unadjusted analysis of the posted summary data; it is not a replacement for the sponsor's analysis. The registry record does not explain the small difference between the sponsor-reported p-value and the recalculated p-value, so no particular cause should be inferred. The recalculated interval adds an estimate and an uncertainty range on the risk-difference scale, while the sponsor's entry provides the result of its stated test. Both results do not show a statistically clear between-group difference in the primary outcome.

The primary record identifies an intent-to-treat population, but the details of the sponsor's statistical implementation, including any adjustments or missing-data procedures, are not reported in the registry record. The sponsor-reported result should therefore be read as the official registry analysis, with the recalculation serving as a transparent unadjusted comparison based on the posted counts.

15. Multiplicity, Missing Data and Analysis Populations

The registry identifies a primary outcome and lists multiple secondary outcomes. It also records 9 outcome measures and 8 analyses. Testing multiple outcomes can increase the chance of at least one apparently notable result arising by chance if all are interpreted without adjustment. The registry record does not report a multiplicity correction, an outcome hierarchy, or a rule defining which secondary results would be confirmatory. Consequently, unadjusted secondary findings should be interpreted cautiously and should not be treated as equivalent in evidential status to the designated primary comparison.

The primary outcome population is identified as intent to treat. The record does not describe the operational definition used for that population, the handling of participants with missing endpoint data, imputation methods, or sensitivity analyses for missingness. It also does not report whether all randomized participants contributed to each secondary analysis or how missing secondary measurements were handled. The outcome denominators are posted by group, but the registry entry does not explain any differences between those denominators and enrollment.

The statistical plan is not reported in enough detail to determine whether the tests, covariate adjustments, subgroup analyses, or missing-data methods followed a prespecified protocol. Interim analyses and stopping rules are also not reported in the registry record. These absences do not demonstrate that such procedures were not used; they limit what can be verified from the registry entries.

These reporting gaps matter for interpretation. Missing outcomes can affect a comparison if their availability is related to group assignment or participant outcome, and multiple testing can make isolated secondary findings less persuasive. Without the relevant methods, the posted results can be described as recorded, but their robustness to those choices cannot be fully assessed.

16. 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.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: cerebrovascular accident (3.0%), pneumonia (1.5%), convulsion (1.5%), renal failure acute (1.5%), hypertensive crisis (1.5%).

The registry reports serious adverse events affecting 11 participants in the NBS-rTMS plus rehabilitation group, with 132 listed at risk, and 7 participants in the sham-rTMS plus rehabilitation group, with 67 listed at risk. Other adverse events are reported for 30 participants in the active group and 15 in the sham group, using the same group denominators. The registry also records 1 death in the active group and 0 in the sham group.

These are descriptive counts. They do not by themselves establish that an event was caused by the assigned intervention, and they do not show how event severity, timing, duration, or relatedness was assessed. The record lists cerebrovascular accident at 3.0% among the leading serious-event terms, and pneumonia, convulsion, acute renal failure, hypertensive crisis, and deep vein thrombosis at 1.5% each. The listed percentages should be read as registry-reported term frequencies; further denominator and attribution details are not reported in the registry record.

Comparing these counts requires care because the group sizes differ, and the event listings do not supply a full account of exposure time or event-level detail. The posted safety information is useful for describing what the registry records, but it is not by itself a causal safety comparison.

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

The primary result is a comparison of the proportion of participants meeting a 5-point UEFM improvement threshold at 6 months post-treatment. The observed proportions were 0.667 with NBS-rTMS plus task-oriented rehabilitation and 0.642 with sham rTMS plus the same rehabilitation. The unadjusted difference is estimated as 0.025, but the interval extends from -0.115 to 0.165 and includes zero. The data do not establish a clear between-group difference on this endpoint.

This finding is not proof that the treatments have identical effects. The uncertainty interval allows for a range of possible differences, including effects in either direction. Nor does the result establish that active rTMS has no effect for any individual participant. The comparison addresses group-level threshold attainment under this trial's design, population, and assessment timeframe.

The result also does not isolate the effect of rehabilitation, because both groups received task-oriented rehabilitation. It compares active, navigation-guided rTMS added to rehabilitation against sham rTMS added to rehabilitation. The endpoint captures whether participants reached a specified change threshold; it does not describe every aspect of motor recovery or the amount of change for participants who did not meet that threshold.

The registry's sponsor-reported chi-squared analysis has p = 0.76, while the unadjusted recalculation gives p = 0.727. Neither analysis provides a statistically clear difference in the primary comparison. The registry does not report enough methodological detail to establish the robustness of results to missing-data assumptions, multiplicity procedures, or other unreported analysis choices.

The conclusions should remain tied to the posted results and stated follow-up. They do not establish what happens at other follow-up times, in patient subgroups not separately reported, or on outcomes for which numerical results are not included in the registry comparison.

18. Why This Trial Matters Statistically

This trial illustrates why effect estimates and their uncertainty are more informative than a significance test alone. The primary outcome has an estimated risk difference of 0.025, but the interval from -0.115 to 0.165 includes both no difference and values on either side. That combination conveys a small observed difference with limited precision, rather than a definitive finding of equivalence or a precisely known treatment effect.

It also highlights the importance of distinguishing a clinically motivated threshold from the underlying scale. Counting participants who reach the 5-point MCID gives a direct threshold-attainment comparison, but it does not show the distribution of individual UEFM changes. Statistical interpretation depends on understanding exactly what the endpoint counts and what information it leaves out.

The randomized, sham-controlled, masked, parallel design provides a structured comparison of active and sham stimulation when both are paired with rehabilitation. At the same time, the registry's limited reporting of the original statistical plan, missing-data methods, and multiplicity strategy constrains independent appraisal of some analytic choices. A transparent account of these details would help readers evaluate how the reported tests and outcomes were selected and handled.

Finally, the sample-size illustrations demonstrate how strongly planning requirements depend on the effect targeted. Detecting a smaller fraction of the observed effect calls for more participants per arm under the stated assumptions. These retrospective planning illustrations are not evidence about the original design or observed power; they show why effect-size assumptions should be stated clearly when planning future studies.

19. 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 registry entry does not report the original sample-size justification or the assumptions used to design the trial. The posted sample-size illustrations instead use the observed effect and specified planning assumptions, so they cannot establish whether the trial was adequately sized for its intended target. The details of allocation concealment and the full statistical analysis plan are also not reported in the registry record.

Although the primary population is labeled intent to treat, the registry does not describe missing endpoint data, imputation, sensitivity analyses, or the handling of participants without a six-month measurement. The posted group denominators are available, but the record does not explain the difference between those outcome denominators and the enrollment entry. These limits make it difficult to assess the sensitivity of the results to missingness or analysis-population decisions.

The primary endpoint dichotomizes a scale change at the 5-point MCID. This is understandable as a threshold-attainment measure, but it does not preserve the amount of change for participants on either side of the cutoff. The registry does not post the full distribution of individual UEFM changes in the primary comparison. A reader therefore cannot assess from this result alone how score changes were distributed within each group.

Secondary results span different measures and tests, while adjustment for multiple comparisons is not reported. The registry's safety summary gives counts and leading serious-event terms but does not provide detailed timing, relatedness, or exposure information. Numerical results are not reported for every named outcome in the posted comparisons. These registry-reporting limitations restrict how far the findings can be interpreted beyond the stated primary comparison and assessment timeframe.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Niche Trial: Navigated Inhibitory rTMS to Contralesional Hemisphere Trial — NCT02089464.
• Registry record last updated 2020-09-01; status last verified 2020-08.
• Results first posted 2020-09-01.
• 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.

23. Record Summary

NCT02089464 is the completed Niche Trial, a randomized, parallel, sham-controlled study of NBS-guided 1 Hz rTMS plus task-oriented rehabilitation versus sham rTMS plus the same rehabilitation after stroke. The registry describes triple masking and lists enrollment of 199. The primary outcome was the number of participants meeting or exceeding the 5-point UEFM MCID at 6 months post-treatment, in an intent-to-treat population.

The primary posted counts were 88 of 132 in the active-rTMS group and 43 of 67 in the sham group. The recalculated risk difference is 0.025, with an interval from -0.115 to 0.165; the registry-reported chi-squared analysis gives p = 0.76. The posted comparison does not establish a clear between-group difference. Secondary measures and adverse-event counts provide additional descriptive information, but multiplicity, missing-data procedures, and the original sample-size justification are not reported in the registry record.