Transcranial Direct Current Stimulation (tDCS)-Enhanced Stroke Recovery: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Transcranial Direct Current Stimulation (tDCS)-Enhanced Stroke Recovery (NCT01007136), a randomized na study. The primary outcome is Upper Extremity Fugl-Meyer.

2. Clinical Question

3. Trial Design

The registry describes a randomized, quadruple-masked, parallel-group trial. It lists an enrollment of 62 and identifies ischemic stroke as the condition. The record does not report the details of sequence generation, allocation concealment, who was masked, or how masking was maintained. The phase is listed as NA. The trial is marked terminated; the registry dates shown are a start in 2009-03 and primary completion in 2014-03. The reason for termination is not reported in the registry record.

The primary clinical comparison is between tDCS with occupational therapy and sham tDCS with occupational therapy. Both arm descriptions refer to a one-hour physical therapy session. In the tDCS arm, 1 mA current was delivered over the lesioned motor cortex during the first 20 minutes. In the sham arm, current was ramped up and down for the first seconds. The record also lists tDCS and sham arms with no arm movement, as well as an fMRI control group with no intervention. That control subgroup did not have clinical intervention or clinical outcome measures performed; its data were used for the fMRI and TMS component.

For the primary outcome, the posted occupational-therapy comparison includes 15 participants in the tDCS arm and 13 in the sham arm. These are the outcome-specific counts, not the overall enrollment. The record says that all subjects with outcome data at the prespecified follow-up were included. It does not report a full accounting of enrollment, allocation, follow-up, exclusions, or missing outcomes by reason. Therefore, the relationship between total enrollment and the outcome-specific counts cannot be fully reconstructed from the registry record. No additional details about treatment adherence, therapy standardization, or follow-up procedures are 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.

Before assignment: Enrolled participants were assigned to groups unless they were found to meet one of the exclusion criteria, or withdrew their consent.

Overall Study

Analysis population for the primary outcome, as defined in the registry: All subjects with outcome data at the prespecified follow-up timepoint were included. "fMRI Control Group no Intervention" subgroup did not have clinical intervention or clinical outcome measures performed, their data was used for the fMRI and TMS component of the study.

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: One subject who did not meet enrollment criteria was erroneously enrolled and was removed by PI from the study immediately after enrollment, prior to randomization. Therefore the total number of enrolled is one more then randomized.

6. Primary Endpoint

The registry lists the primary outcome as Upper Extremity Fugl-Meyer, measured over 2 weeks.

The primary endpoint is the Upper Extremity Fugl-Meyer measure at 2 weeks. It is a continuous motor outcome, reported as a mean with a standard deviation. The registry describes it as an upper-extremity motor outcome measure with scores from 0-66; higher values mean better performance. It is used to quantify motor function in the area relevant to the trial’s stated question about hand weakness and recovery after stroke.

A continuous score retains more gradation than a simple classification such as improved or not improved. It can represent differences in performance across participants, and a comparison of arm means describes the average score in each group. That summary does not show how each participant changed from baseline, because a baseline value or change-from-baseline result is not included in the posted primary outcome summaries. Nor does the group mean describe the full distribution of individual responses.

At the prespecified follow-up, the registry says that participants with outcome data were included. The record does not report a baseline-adjusted analysis or a threshold for defining a clinically important difference. The score range and direction of interpretation help explain the measure, but they do not by themselves establish how much difference would matter clinically. The interpretation should therefore keep the outcome’s scale, timing, and available-data population in view.

7. Results Posted in the Registry

• tDCS and Occupational Therapy: mean 30.20 versus 36.80 on control; difference -6.60 (95% CI -22.83 to 9.63), standardized effect d = -0.30; z-test p = 0.425.

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.

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:
  • tDCS and Occupational Therapy: mean 19.70 versus 30.90 on control; difference -11.20 (95% CI -28.86 to 6.46), standardized effect d = -0.54; z-test p = 0.214.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between tDCS and Occupational Therapy and the control. The interval gives the range of effects that remain compatible with the data.

The registry lists one secondary clinical outcome: the Wolf Motor Function Test at 3 months. Thus, the record does not offer a set of several posted secondary clinical endpoints from which to judge consistency across many measures. The occupational-therapy comparison on that measure points in the same general direction as the primary comparison: the recalculated average is lower in the tDCS arm than in the sham arm. Its interval also includes zero. This directional alignment is a descriptive feature, not independent confirmation of a treatment effect.

The secondary outcome concerns motor function and is related to the primary focus on upper-extremity motor performance, but it is a distinct measure taken at a different follow-up time. Agreement in direction across related measures can be informative, while it cannot make the estimates independent or remove their uncertainty. The registry record lists no reported secondary analyses. The numerical comparison is an unadjusted recalculation from the posted arm summaries, so it should not be treated as a registry-reported confirmatory finding.

Unadjusted secondary results carry less weight when many outcomes, timepoints, or comparisons may have been considered. Even without evidence that many analyses were conducted, testing multiple endpoints can increase the chance that at least one result appears unusual by chance. The registry lists 14 outcome measures, but only one secondary outcome is identified in the information summarized for this result; the record does not specify which measures were analyzed, how they were prioritized, or whether any adjustment for multiple testing was planned. No multiplicity correction should be presumed.

The appropriate reading is therefore restrained: the single posted secondary clinical comparison is directionally consistent with the primary estimate, but it is uncertain, unadjusted, and not reported as a formal registry analysis. It adds context about another motor measure and follow-up, but it does not resolve the precision limitations of the primary result or establish a broader pattern across secondary endpoints.

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

• Wolf Motor Function Test

9. Statistical Interpretation

10. Statistical Methods Explained

The primary measure is continuous, so the registry reports a mean and standard deviation for each arm. A mean represents the average score among participants contributing outcome data. A standard deviation describes how spread out participant scores are around that mean; it is not the uncertainty in the mean itself. In these results, the tDCS arm has a mean of 30.2 and standard deviation of 21.2, while the sham arm has a mean of 36.8 and standard deviation of 22.4. The observed spread is substantial relative to the arm means, which is relevant when judging how much information the available participants provide about a difference between group averages.

The displayed mean difference is an unadjusted recalculation using the two arm means. Its direction is tDCS minus sham, so a negative value means the tDCS arm’s observed mean is lower. The recalculated difference is -6.6 units. It is expressed in the original score units, which makes its scale directly interpretable against the Fugl-Meyer measure. It is not adjusted for baseline values or other participant characteristics. A difference in observed means can reflect the treatment contrast, chance variation, differences in who contributed outcome data, or other features that an adjusted design or analysis might address; the posted summaries alone cannot separate those possibilities.

The confidence interval gives a range of values compatible with the estimate under the method’s assumptions. For this comparison, the interval runs from -22.83 to 9.629. An interval that crosses zero does not establish that there is no effect; it indicates that the data do not narrowly distinguish a negative difference from no difference or a positive difference. The registry record does not state the confidence level for the interval. In general, confidence intervals are useful because they display both the estimated direction and the precision, whereas a p-value alone does not show the range of plausible effect sizes.

The unadjusted p-value is 0.425. In general, a p-value is calculated under a null hypothesis and a statistical model; it measures the compatibility of the observed data with that model, not the probability that a treatment is beneficial or ineffective. Here, the p-value is not adjusted for other endpoints or comparisons. The registry record does not report a multiplicity procedure, a prespecified statistical analysis plan, or a registry-reported analysis for this primary comparison. It is therefore best treated as a descriptive, unadjusted inferential statistic accompanying the recalculation, rather than as a complete account of the trial’s planned analysis.

The comparison also reports a standardized effect size of -0.303. A standardized effect expresses the mean difference in standard-deviation units rather than in Fugl-Meyer points. In general, this can help compare effects across measures with different scales, but it removes the original scale’s direct interpretation. The sign retains the same direction: negative indicates a lower tDCS mean relative to sham under the stated subtraction order. The pooled standard deviation used in the recalculation is 21.76. The standardized effect is not a separate outcome, and it does not resolve the uncertainty reflected by the confidence interval.

The outcome-specific analysis population matters. The registry says that all subjects with outcome data at the prespecified follow-up were included. It does not state that missing outcomes were imputed, nor does it describe an intention-to-treat analysis or a per-protocol analysis. Those methods should not be assumed. If outcome availability differs between groups or is related to measured performance, a complete-case summary can represent a selected subset of the randomized participants. The registry record does not provide enough information to evaluate that possibility.

General statistical context: random assignment is intended to make treatment groups comparable on average, including on characteristics not measured at baseline, but randomization does not guarantee balance in a small realized sample. Masking can limit some forms of influence on treatment delivery or outcome assessment, though the registry does not specify who was masked or how masking success was assessed. The parallel design assigns participants to groups for comparison over the same trial period; the registry does not report further details of assignment or follow-up that would support a more specific account.

General statistical context: variability and sample size jointly affect precision. Greater variation in individual scores makes a group mean less precise, while more observed participants generally provide more information, subject to the assumptions of the analysis and the quality of the data. Here, the outcome-specific counts are 15 and 13 in the two occupational-therapy arms, and the standard deviations are large relative to the difference estimate. The wide interval is consistent with limited precision. This explanation describes general statistical principles; it does not establish the reason the trial enrolled or analyzed the number of participants it did.

For planning illustrations, the posted calculations use the observed effect and specified assumptions described with the planning figures. Those are not the trial’s original design calculations: the registry record does not report the original sample-size assumptions. A planning calculation based on an observed effect is sensitive to that effect estimate, which is uncertain in a small sample. Such illustrations can show how required group size changes under the chosen assumptions, but they cannot substitute for a prespecified design rationale or an observed treatment effect.

11. Confidence Intervals and Precision

The primary mean difference is -6.6 units, with a confidence interval from -22.83 to 9.629. Because this interval includes zero, the posted data do not distinguish the observed difference from no mean difference at the interval’s range of uncertainty. The interval also includes values on both sides of zero, so it allows for an average difference favoring either arm. The registry record does not report the confidence level for this interval; the numerical limits should be read as posted rather than assigned an unstated confidence level.

The interval is wide in relation to the point estimate. That width is a practical expression of limited precision: the estimate gives a direction and central value, but the available data leave a broad range of possible mean differences. The outcome-specific counts are 15 and 13, and the reported standard deviations are 21.2 and 22.4. Group means are summaries, while the standard deviations indicate considerable participant-to-participant variation. With relatively few outcome observations and substantial spread, a mean difference can be estimated imprecisely.

Precision is distinct from whether a result crosses a conventional statistical threshold. A p-value of 0.425 does not make the confidence interval narrow, and it does not show that the arms are alike. Conversely, the interval’s inclusion of zero does not show that the true mean difference is exactly zero. To demonstrate similarity within a clinically meaningful range would require a suitable prespecified margin and an analysis designed for that question; such a margin is not reported in the registry record.

The interval is based on the unadjusted recalculation from the posted summary statistics, and it concerns the outcome-data population described in the registry. It does not capture every possible source of uncertainty, such as missing outcomes or unreported analytic choices. The result should therefore be read as a fairly imprecise estimate from the available summaries, not as a definitive estimate of the treatment contrast for all enrolled participants.

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 planning figures are participants per arm, not total participants and not total events. They are illustrations based on the observed effect, not the trial’s original design calculations; the original design assumptions are not reported in the registry record. The stated planning 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 set to the stated fraction of the observed effect. The separate rule for time-to-event calculations is not relevant to these continuous outcomes.

The 80% power column means the number of participants per arm estimated to give an 80% chance of detecting the specified effect under those assumptions if that effect is the true effect. The 90% column expresses the corresponding planning target for a 90% chance. These are design probabilities under a model, not guarantees for an individual study. For the primary comparison, planning for 100% of the observed effect gives 171 participants per arm for 80% power and 229 participants per arm for 90% power. Planning for 75% of the observed effect gives 304 and 407 participants per arm, respectively; planning for 50% gives 683 and 914.

The pattern matters more than treating any one figure as a definitive target. A smaller effect is harder to distinguish from random variation, so detecting a smaller fraction of the observed effect requires more participants under the same assumptions. The observed effect itself is uncertain, and basing a planning illustration on it can make the resulting figures sensitive to chance variation in this trial. These figures are not observed power. They do not indicate the probability that the trial’s result is correct or the chance that an effect exists; they are planning illustrations under the stated assumptions.

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, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -6.600; pooled standard deviation σ = 21.762.
2. n = 2 × (1.96 + 0.842)² × 21.762² / -6.600² = 170.7, rounded up to 171 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
delta <- -6.6                      # observed difference in means
sigma <- 21.7620700372849                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^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 (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(1007136)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 171 (80% power), 229 (90% power)
 75% of observed effect: n per arm = 304 (80% power), 407 (90% power)
 50% of observed effect: n per arm = 683 (80% power), 914 (90% power)
power.t.test: 171.6 
Simulated power at n = 171 per arm: 0.798 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-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. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when a study evaluates more than one outcome, timepoint, treatment contrast, or subgroup. If many hypotheses are tested, the chance of at least one apparently noteworthy result by chance can increase. The registry lists 14 outcome measures and one secondary outcome is identified in the posted clinical results. It does not report which of the listed measures were formally analyzed, how the primary outcome was prioritized in the statistical plan, or whether any multiplicity adjustment was planned or performed. The posted unadjusted p-values should therefore not be read as accounting for all possible comparisons.

The record lists no reported analyses for the primary comparison and no reported analyses for the secondary outcome. The comparisons discussed are unadjusted recalculations from arm-level summary statistics. The registry record does not report a prespecified statistical analysis plan, any interim analyses, stopping rules, subgroup analysis plan, or adjustment for baseline covariates. These items should be treated as not reported in the registry record, rather than inferred from the trial design or the posted outcome summaries.

Missing data also limit interpretation. For the primary endpoint, the record says that all subjects with outcome data at the prespecified follow-up were included. That describes an available-outcome population; it does not establish that all randomized participants contributed data. The record does not report the number or reasons for missing primary outcomes by assigned arm, how missing values were handled, or whether sensitivity analyses assessed the effect of missingness. It also does not report a complete participant flow that would reconcile enrollment with outcome-specific counts.

In general, complete-case summaries can be biased if outcome availability is related to treatment assignment or to participant outcomes, although the available record cannot establish whether that happened in this trial. Nor does the registry provide enough information to determine whether the analysis population followed an intention-to-treat principle. The stated population should be described as participants with outcome data at the prespecified follow-up, without assigning it a stronger analysis label. These gaps matter because conclusions from randomized assignment depend in part on how follow-up and analysis preserve the intended comparison.

15. 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: recurrent stroke (5.9%), hip fracture (5.9%), death (5.3%), mental status change hospitalisation (5.3%).

The registry reports safety counts for five groups, with denominators labeled as participants at risk. In the tDCS-and-occupational-therapy group, serious adverse events affected 2 of 19 at risk, other adverse events affected 9 of 19, and 1 death was reported. In the sham-and-occupational-therapy group, serious events affected 2 of 17, other events affected 3 of 17, and no deaths were reported. For the groups with no arm movement, serious events affected none of 6 in the tDCS group and none of 4 in the sham group; other events affected 2 of 6 and none of 4, respectively. The fMRI control group had no serious or other adverse events reported among 15 at risk and no deaths.

These counts are descriptive and should be read with their group sizes in mind. The record lists serious-event terms including recurrent stroke, hip fracture, death, and mental status change hospitalisation, each with a percentage, but does not assign those terms to particular treatment groups in the information summarized. The adverse-event denominators differ from the outcome-specific counts for the primary comparison. The registry record does not provide further detail about event timing, severity classification, relatedness assessment, or how the risk groups were defined. The counts alone do not establish that an event was caused by an intervention or permit a complete comparative safety analysis.

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

The posted primary data show a lower mean upper-extremity Fugl-Meyer score in the tDCS-plus-occupational-therapy group than in the sham-plus-occupational-therapy group at 2 weeks. The unadjusted recalculated difference is -6.6 units, and the interval from -22.83 to 9.629 spans zero. This combination conveys both the observed direction and the uncertainty: the point estimate favors a higher average score in the sham group, while the interval does not tightly identify the size or direction of the underlying mean difference.

The result does not establish that the groups are equivalent. An interval that includes zero can arise because the true difference is small, because the data are too imprecise to distinguish a difference, or through other features not resolvable from the summary. The registry record does not report an equivalence margin or a non-inferiority design. Similarly, the unadjusted p-value of 0.425 does not establish that there is no treatment effect and is not the probability that the observed result is due to chance.

The figures also do not establish whether any difference is clinically important. The scale range and the fact that higher scores mean better performance clarify direction, but a threshold for an important change is not reported. The primary result is a comparison of group means at follow-up, not an account of each participant’s change from baseline. The record does not provide the information needed to infer individual improvement, recovery trajectories, or how many participants experienced a meaningful change.

The findings should be confined to the posted comparison, endpoint, follow-up, and available outcome population. The record describes additional groups and a separate fMRI/TMS component; those data do not automatically answer the clinical comparison. No reason for trial termination is reported, and the available outcome summaries do not explain the termination. More generally, one small outcome-specific comparison with an imprecise interval cannot by itself settle whether the intervention changes motor outcomes in other settings or populations. It gives a limited estimate with substantial uncertainty, not medical advice or a basis for an individual treatment decision.

17. Why This Trial Matters Statistically

This trial is statistically instructive because it separates a point estimate from the strength of evidence around that estimate. The observed mean difference has a direction, but its confidence interval extends across zero and is wide. A reader who focuses only on the sign of the point estimate could overstate what the data establish; a reader who focuses only on the p-value could mistakenly treat a non-small value as proof of no effect. Precision and uncertainty are central to interpreting a small available-outcome comparison.

The registry also illustrates the importance of distinguishing enrollment from the population contributing to a specific endpoint. Enrollment is 62, while the primary occupational-therapy comparison has 15 and 13 outcome observations. The record states that participants with outcome data at follow-up were included, but does not explain the full movement from enrollment to those counts. Transparent participant flow and missing-data methods are important for understanding how closely an outcome analysis reflects the randomized groups.

Another statistical issue is the boundary between registry-reported analyses and post hoc recalculation. The posted means and standard deviations support a straightforward unadjusted comparison, but the record lists no reported inferential analyses. That distinction matters: a calculation from summaries can aid interpretation, but it does not recover unreported details of a planned model, covariate adjustment, multiplicity strategy, or sensitivity analysis.

Finally, the presence of multiple listed outcomes and additional study groups makes a narrowly defined contrast essential. The main clinical question concerns active versus sham stimulation when both groups receive occupational therapy. Groups without arm movement and an fMRI control subgroup have different roles in the record and should not be folded into that contrast. A clear account of the target comparison, outcome timing, analysis population, and uncertainty makes the statistical reading more faithful to what the registry actually documents.

18. 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 record leaves important design and analysis details unresolved. It does not report the original sample-size justification or its assumptions, so the planning illustrations based on the observed effect cannot be taken as the trial’s original design rationale. The reason the trial was terminated is also not reported in the registry record. Termination status alone does not explain whether enrollment, follow-up, or analysis was affected.

The primary comparison is based on outcome-specific counts of 15 and 13, and the registry describes inclusion of people with outcome data at the prespecified follow-up. A full participant-flow account, reasons for missing outcomes, and missing-data methods are not reported. This makes it difficult to assess how the observed-data population relates to all randomized participants. Baseline Fugl-Meyer scores and an analysis of change from baseline are not included in the posted primary summaries, nor is a baseline-adjusted estimate reported.

The results are means and standard deviations rather than participant-level data or a complete distributional description. The registry record does not report an analysis model, diagnostics, or sensitivity analyses. It also does not report who was masked, details of allocation concealment, treatment adherence, therapy standardization, or a clinically important difference threshold. These omissions do not prove that such procedures or analyses did not occur; they mean they are not reported in the registry record.

The broader study includes no-arm-movement groups and a no-intervention fMRI control subgroup, but the clinical question addressed by the main comparison is the tDCS-plus-therapy arm versus sham-plus-therapy. The fMRI subgroup did not have clinical outcome measures performed. The information summarized does not provide enough detail to combine those groups or assess all study objectives. In addition, the registry lists 14 outcome measures while the posted clinical summary identifies one secondary outcome; the status and analysis of the other measures are not clear from the registry record.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Transcranial Direct Current Stimulation (tDCS)-Enhanced Stroke Recovery — NCT01007136.
• Registry record last updated 2020-09-22; status last verified 2020-09.
• Results first posted 2020-09-22.
• 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.

22. Record Summary

The registry identifies NCT01007136 as Transcranial Direct Current Stimulation (tDCS)-Enhanced Stroke Recovery, with the official title TDCS-enhanced Stroke Recovery and Cortical Reorganization. The sponsor is University of Texas Southwestern Medical Center. The study is listed as randomized, quadruple-masked, and parallel, with an enrollment of 62. Its condition is ischemic stroke, its phase is listed as NA, and its status is terminated. The recorded start is 2009-03 and primary completion is 2014-03.

The primary clinical outcome is the Upper Extremity Fugl-Meyer measure at 2 weeks. In the occupational-therapy comparison, the unadjusted recalculated mean difference is -6.6 units, with a confidence interval from -22.83 to 9.629 and an unadjusted p-value of 0.425. The registry record lists no reported analysis for this comparison. The outcome summaries include participants with outcome data at follow-up; the registry does not report the original design assumptions, a complete missing-data account, or the reason for termination.