This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Theta Burst Stimulation for Schizophrenia (NCT03288779), a na na study. The primary outcome is Brief Assessment of Cognition (BACS) Composite T Score.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03288779 |
| Phase | NA |
| Condition | Schizophrenia, Schizoaffective Disorder |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 6 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Duke University |
| Results posted | Yes |
2. Clinical Question
Population
The registry lists schizophrenia and schizoaffective disorder as conditions. Its summary describes inpatient individuals with schizophrenia and says the intended group had minimal positive symptoms and predominant cognitive deficits. Six participants were enrolled.
Intervention
The intervention was theta burst stimulation, described as a device intervention. The study summary presents it as a form of transcranial magnetic stimulation intended to evaluate effects on working memory and related cognitive deficits.
Comparator
This was a single-group, open-label study, with no masking. The registry does not describe a separate control group or randomized comparison. The listed arm is therefore not a like-for-like control for estimating a treatment contrast.
Primary question
The primary endpoint was change from baseline in the Brief Assessment of Cognition composite T-score. The registry describes a mean change and labels the timeframe as 30 minutes. It does not report the observed change or its confidence interval, so the direction and precision of the posted endpoint result cannot be assessed.
3. Trial Design
This completed study, NCT03288779, is titled “Theta Burst Stimulation for Schizophrenia” and is sponsored by Duke University. The registry lists schizophrenia and schizoaffective disorder as conditions and records six participants enrolled. The recorded start date is 2017-10-24 and the primary completion date is 2018-06-30.
The design is listed as single group, with allocation marked NA and masking listed as none. The arm description calls it a pilot open-label study. These details matter for interpretation: the registry does not describe a randomized comparison or a separate control group, so any change from baseline would be a within-participant observation rather than a controlled estimate of the difference between interventions.
The intervention is theta burst stimulation. The summary frames the study as an evaluation of effects on working memory in people with schizophrenia and discusses gamma oscillations, neural activity, quality of life, and cortical inhibition as areas of interest. The listed secondary outcome is change in gamma and theta oscillations measured by EEG. The registry record does not provide further details about procedures, treatment schedule, or the assessment schedule beyond the primary endpoint timeframe.
The phase is listed as NA. A protocol-level sample-size justification, eligibility details beyond the summary, and additional design rationale are not reported in the registry record. The study's completed status indicates that the record marks the study complete; it does not, by itself, establish that outcome results were posted. In this record, the primary endpoint is described, but its numerical result is not reported.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Patients With a Diagnosis of Schizophrenia |
|---|---|
| STARTED | 6 |
| COMPLETED | 3 |
| NOT COMPLETED | 3 |
Reasons for not completing this period:
| Reason | Patients With a Diagnosis of Schizophrenia |
|---|---|
| Withdrawal by Subject | 3 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Patients With a Diagnosis of Schizophrenia |
|---|---|---|
| Participants analysed | 6 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 6 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age, Continuous | years | 33 (SD 7) |
| Sex: Female, Male: Female | Participants | 2 |
| Sex: Female, Male: Male | Participants | 4 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 |
| Race (NIH/OMB): White | Participants | 4 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 6 |
| Brief Assessment of Cognition (BACS) Composite T Score | Composite T- Score | 26.3 (SD 17.4) |
6. Primary Endpoint
The registry lists the primary outcome as Brief Assessment of Cognition (BACS) Composite T Score, measured over 30 minutes.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | Composite T- Score |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the Brief Assessment of Cognition in Schizophrenia (BACS) composite T-score, expressed as mean change from baseline. The registry says the score is a weighted average of age-normalized T-scores from the BACS subtests: Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Semantic Fluency, Letter Fluency, and Tower of London. The tasks were performed and results recorded on an iPad.
The endpoint is intended to summarize performance across several cognitive tasks in a single measure. As a general statistical concept, a composite can represent performance across multiple related domains, while a mean change expresses the average difference from participants' baseline measurements. The record states that positive changes indicate better performance and gives possible bounds of -131 and 131 for the change score. These bounds describe the scale, not the observed result.
The registry lists a 95% confidence interval as the measure of dispersion and gives the timeframe as 30 minutes. It does not report the mean change or the confidence interval itself. The record also does not clarify the timing represented by the 30-minute timeframe beyond listing it for this endpoint. Consequently, the endpoint's definition and intended direction are available, but its observed magnitude and statistical precision are not.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a cognitive endpoint and a study completed with six participants, but it does not post a numerical result for the endpoint. There is no reported mean change from baseline, confidence interval, or analysis result to interpret. The record therefore does not establish whether the measured score changed, in which direction it changed, or how precisely any estimate was obtained.
The design also places a limit on what a result could establish. This is a single-group, open-label study, not a randomized comparison. A within-participant change can describe how measurements differed from baseline in the enrolled group, but, without a separate comparison group, it cannot isolate the intervention's effect from other explanations for change. The registry does not report masking, and it lists masking as none. This is relevant when interpreting performance-based outcomes, since participants and study personnel were not masked according to the record.
The endpoint is described as mean change, with a 95% confidence interval intended to express uncertainty around that estimate. In general, a confidence interval conveys a range of values compatible with the data and the stated method; a narrower interval indicates greater precision than a wider interval. Here, no interval is posted, so precision cannot be judged. The six-person enrollment is important context for any estimate, but it cannot substitute for the missing estimate or its uncertainty.
The registry lists a secondary EEG outcome concerning change in gamma and theta oscillations. It does not provide a numerical result for that outcome either. The study summary explains why oscillations were of interest, but a rationale is not evidence of a measured result. The number of outcome measures is recorded as two and the number of analyses as zero; the record does not provide analysis outputs to compare across outcomes.
Sample-size illustrations displayed with the page are planning calculations, not evidence about the trial's observed outcome or its power. The record describes those illustrations as based on the observed effect and a hypothetical two-arm, equal-allocation design, with a normal approximation and a two-sided significance level of 0.05. Those assumptions do not change the actual single-group design, and they do not supply the missing endpoint result. No conclusion about the size or direction of an observed effect should be drawn from a planning illustration.
9. Statistical Methods Explained
The registry identifies the primary outcome as a continuous measure summarized by a mean. In general, a mean represents the arithmetic average of observations, while a mean change describes the average of participants' changes from baseline. The record specifies that the BACS composite change is calculated using a weighted average of subtest T-scores normalized for age. It describes the intended score direction: positive changes indicate better performance. These definitions explain what an eventual estimate would represent, but the numerical estimate is not reported in the registry record.
What does a confidence interval communicate?
The endpoint lists a 95% confidence interval for dispersion. As a general explanation, a confidence interval communicates the uncertainty around an estimated quantity under the method used to calculate it. It is not a guarantee that the true value lies inside a particular interval, and it does not by itself establish clinical importance. Width matters: a wider interval reflects less precision than a narrower one. Because the registry does not report the interval or the mean change, neither the estimate nor its precision can be assessed from this record.
A confidence interval is especially relevant when interpreting a small study because the observed estimate and its uncertainty should be considered together. Enrollment was six. That fact alone does not determine the interval width; variability in the measurements and the analysis method also matter. Neither the observed variability nor the calculation details for an endpoint estimate are reported. It would therefore be inappropriate to infer a particular degree of precision from enrollment alone.
What does the design allow?
This is a single-group study with no masking, and allocation is listed as NA. The endpoint is framed as change from baseline, which gives a within-group summary. In general, within-group change and a between-group treatment contrast answer different questions. A randomized controlled comparison can estimate how outcomes differ between assigned groups, while a single-group pre-post summary describes change observed in one group. The registry does not describe a control group that could provide the former comparison. Thus, even if a change estimate were available, the design would not identify how much of that change was attributable to the intervention rather than other influences.
Open-label status is also part of the context. In general, knowledge of the intervention can influence expectations, behavior, or the assessment process. This does not show that such influence occurred in this study; it identifies a consideration when reading an unmasked study. The registry records masking as none and does not describe additional steps intended to address this issue.
How should the planning illustrations be read?
The sample-size illustrations are planning calculations and should not be read as observed trial results or as observed power. The record describes the illustration assumptions as a two-sided significance level of 0.05, equal allocation between two hypothetical arms, and a normal approximation. It also states that the effect to detect is a specified fraction of the observed effect. These are assumptions for the illustrations, not a description of this study's design: the actual study is listed as single group. The planning table can show how sample-size requirements would vary under its stated assumptions, but it cannot repair the lack of a control group or provide the missing endpoint estimate.
In general, over-dispersion means that data vary more than a particular statistical model expects. When present, a model that understates variation can give uncertainty estimates that are too small. The registry record does not report an over-dispersion assessment or a model for the primary endpoint, so no claim about its relevance to this analysis can be made.
Are hypothesis tests or adjustments reported?
The registry records zero analyses, and no primary endpoint test statistic or p-value is reported. The planning illustration's significance-level assumption is not evidence that the study used that threshold for its outcome analysis. The record does not report a statistical analysis plan, covariate adjustment, or methods for handling repeated measurements. These details should not be inferred from the endpoint description alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures: the BACS composite T-score as the primary outcome and change in gamma and theta oscillations measured by EEG as a secondary outcome. It records zero analyses, and numerical outcome results are not reported in the registry record. The relationship between the outcomes, any additional tests, and any plan for controlling false-positive findings across multiple analyses are not reported in the registry record.
As a general statistical issue, testing several outcomes or several versions of an outcome can increase the chance of finding an apparently notable result by chance. Methods to address multiplicity may include defining a primary endpoint in advance or adjusting interpretation across tests. The registry identifies a primary and a secondary outcome, but does not report whether a formal multiplicity procedure was planned or used. The presence of a primary outcome should not be taken as evidence that such a procedure was applied.
The endpoint is defined as change from baseline, but missing-data rules are not reported in the registry record. The record does not say how incomplete assessments, withdrawals, or unavailable measurements were handled, nor does it describe imputation or sensitivity analyses. These omissions prevent assessment of whether missing observations could have influenced an estimate.
The analysis population is also not reported in the registry record. Although six participants were enrolled, the record does not specify how many contributed to each endpoint analysis or whether an intention-to-treat, per-protocol, or other population was used. The enrolled total therefore should not be assumed to equal the number analyzed for every outcome. Further details about exclusions and endpoint-specific denominators are not available in this record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Patients With a Diagnosis of Schizophrenia | 0 | 6 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Patients With a Diagnosis of Schizophrenia | 0 of 6 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Patients With a Diagnosis of Schizophrenia | 0 of 6 |
The registry safety row is titled “Patients With a Diagnosis of Schizophrenia” and lists six participants at risk for serious adverse events and six at risk for other adverse events. It records zero participants affected by serious adverse events, zero affected by other adverse events, and zero deaths. These are the event counts reported for this record.
These figures should be read as counts within the recorded study group, not as proof that no adverse events could occur or that the intervention is safe. The group was small, and the registry does not provide event descriptions because no serious adverse event terms are listed. It also does not provide further detail about how events were collected, the length of safety observation, or whether every participant completed all safety assessments. Those details are not reported in the registry record.
As a general statistical point, observing zero events in a small group does not establish that the underlying event risk is zero. The counts are useful as a description of what the registry reports, but they do not give a precise estimate of risk or support a comparison with another treatment group. This study has no listed control group, so the safety counts cannot be interpreted as a controlled difference.
12. What the Result Does, and Does Not, Mean
The posted record describes a pilot, open-label, single-group study of theta burst stimulation and defines a cognitive outcome based on the BACS. It also lists an EEG outcome concerning gamma and theta oscillations. The record gives the enrollment and endpoint definitions, but it does not report numerical results for these outcomes. Accordingly, this page cannot characterize the observed cognitive change, its direction, or its precision, nor can it describe a measured EEG change.
The endpoint's stated interpretation is that positive changes indicate better performance. That explains how a reported score would be read, but it is not an observed finding. Similarly, the study summary's interest in working memory and neural oscillations describes the study rationale, not a demonstrated result. No treatment conclusion follows from the endpoint definition or the rationale alone.
Even with complete within-group results, the single-group design would not provide a randomized treatment contrast. Change from baseline can be informative descriptively, but other influences over time cannot be separated from intervention effects using a control comparison that the registry does not describe. Open-label status and the absence of masking are further features to consider when interpreting performance-based measures.
The registry reports zero serious adverse events, zero other adverse events, and zero deaths among the recorded group. These counts describe the posted safety record, but they do not establish the absence of risk. The study's six-person enrollment and lack of a comparison group limit what can be inferred about safety rates or differences between interventions.
Overall, the record supports a description of the study design, intended outcome measures, and recorded safety counts. It does not support a conclusion about whether the intervention changed cognition or EEG measures. The absence of posted outcome estimates is distinct from a finding of no effect: the result is not reported in the registry record.
13. Why This Trial Matters Statistically
This record illustrates why statistical interpretation begins with the design and the availability of results, not just the name of an endpoint. The BACS composite is described in detail, including its subtests, score direction, and confidence-interval format. Yet without the mean change or interval, readers cannot assess the magnitude or precision of the outcome. A well-defined endpoint is necessary for interpretation, but it is not a substitute for a reported estimate.
The single-group design is equally important. A change-from-baseline measure can summarize what happened within the enrolled group, but it does not offer the same inference as a randomized comparison. This distinction helps prevent overstatement when reading pilot or open-label research. The six-person enrollment also makes it especially important not to confuse a planning illustration with observed evidence or with power achieved in the study.
The record gives planning assumptions for sample-size illustrations, including a hypothetical two-arm allocation, even though this trial is listed as single group. Recognizing that difference prevents those calculations from being mistaken for the actual study plan. The illustrations concern hypothetical planning conditions; they cannot provide missing outcome data or create a control comparison.
Finally, the safety counts show the value and limits of registry summaries. Zero recorded events is a descriptive finding for the listed group, while uncertainty about risk, observation, and comparison remains. Statistically, a careful account should keep separate what the record measures, what it reports, and what its design can support. Here, the strongest reading is a transparent description of the available design and safety information, alongside a clear statement that efficacy-related outcome results are not reported in the registry record.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation for interpreting outcomes is that numerical results are not reported in the registry record. The BACS endpoint's mean change and 95% confidence interval are absent, and the EEG outcome has no numerical result. The record also lists zero analyses, so there are no posted analysis outputs to evaluate. The study's completed status does not fill these gaps.
The study enrolled six participants and is listed as single group, open label, with no masking. There is no described randomized control group for comparison. These design features limit the interpretation of any within-group change and restrict comparisons with alternative care. Because no result is posted, the size of any observed change and its uncertainty cannot be assessed in addition to those design constraints.
The registry provides limited detail about outcome timing: the BACS timeframe is listed as 30 minutes, but further assessment-timing information is not reported in the registry record. It also does not report the statistical analysis plan, missing-data procedures, endpoint-specific analysis populations, or multiplicity handling. The number enrolled should not be assumed to equal the number with complete measurements or included in an analysis.
The summary describes an intended population of inpatients with schizophrenia and discusses cognitive deficits, while the registry lists both schizophrenia and schizoaffective disorder as conditions. Further eligibility and participant-characteristic details are not reported in the registry record. This limits assessment of how closely the enrolled group corresponds to any broader population.
Safety interpretation is constrained by the small recorded group and the lack of a comparison arm. The registry records no serious adverse events, other adverse events, or deaths, but it does not provide additional safety-collection or observation details. These limitations should be kept distinct from the reported counts themselves.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Theta Burst Stimulation for Schizophrenia — NCT03288779.
- Registry record last updated 2019-11-25; status last verified 2019-08.
- Results first posted 2019-11-25.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT03288779 is a completed, Duke University-sponsored, single-group, open-label study of theta burst stimulation for schizophrenia. The registry records six participants enrolled, with start date 2017-10-24 and primary completion date 2018-06-30. Masking is listed as none, and allocation and phase are listed as NA.
The primary outcome is mean change from baseline in the BACS composite T-score, with a 95% confidence interval listed and a timeframe of 30 minutes. The secondary outcome is change in gamma and theta oscillations measured by EEG. Numerical outcome results and analysis outputs are not reported in the registry record. The safety listing records zero serious adverse events, zero other adverse events, and zero deaths among six participants at risk for each adverse-event category.