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 Effect of Repetitive Transcranial Magnetic Stimulation on Language in Alzheimer's Disease (NCT00814697), a na phase 2 study. The primary outcome is Cognitive Assessment Task Scores Before, During and After rTMS..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00814697 |
| Phase | Phase 2 |
| Condition | Alzheimer's Disease, Aphasia, Dementia |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 12 |
| Arms in the primary outcome | n/a |
| Lead sponsor | The New York Memory Services |
| Results posted | Yes |
2. Clinical Question
Population
Patients with Alzheimer's disease. Aphasia and dementia are also listed among the conditions associated with the study. The registry record does not report further eligibility details or a demographic description of those enrolled.
Intervention
Repetitive transcranial magnetic coil stimulation, described as bilateral stimulation over the right and left dorsolateral prefrontal cortex. The record states that patients received 4 sessions over 2 weeks.
Comparator
There was no separate control group. The study is recorded as single-group and open-label, so it does not provide a concurrent comparison with sham stimulation, usual care, or another intervention.
Primary question
The registered primary outcome concerns cognitive assessment task scores before, during, and after rTMS. The tasks include measures of language and broader cognition. The record does not report the observed scores or a statistical estimate of change, so it does not establish how scores varied during the study.
The study is titled Effect of Repetitive Transcranial Magnetic Stimulation on Language in Alzheimer's Disease and is registered as NCT00814697. Its stated aim is to investigate targeted rTMS in relation to expressive language. In statistical terms, the available description identifies the population, intervention, and outcome assessments, but not an intervention-versus-control effect. Because all participants received rTMS, score changes over time, if reported, would be within-person or within-group observations rather than a randomized treatment contrast. Such changes alone would not separate an intervention effect from other explanations, including practice on repeated tasks or changes over time. The registry record does not report outcome estimates with which to assess even the direction or precision of any observed change.
3. Trial Design
This is a completed phase 2 study with a single-group, open-label design. The registry lists an enrollment of 12. Allocation is recorded as not applicable, and masking is recorded as none. There is no parallel control arm in the record, so the design does not support a like-for-like comparison between participants receiving rTMS and participants receiving a different treatment or no stimulation.
The intervention is repetitive transcranial magnetic coil stimulation. The arm description identifies stimulation over the right and left dorsolateral prefrontal cortex and states that patients received 4 sessions over 2 weeks. It names the Magstim Rapid2 stimulator and reports a peak magnetic field of 0.5-3.5 Tesla at 100% output. The record does not fully describe the stimulation protocol: the arm description is truncated, and further details are not reported in the registry record.
The primary outcome is described as cognitive assessment task scores before, during, and 4 weeks after rTMS. The named assessments are the Boston Diagnostic Aphasia Examination, CFL Category naming, and Mini-Mental State Examination. The primary-outcome timeframe is listed as 6 weeks, while its description identifies the post-treatment assessment as 4 weeks after treatment. The record does not clarify the timing of each assessment within the stated timeframe.
The study started in 2008-12, had primary completion in 2011-12, and is marked completed. The sponsor is The New York Memory Services. The record does not report a randomized allocation procedure, a masking procedure, or a comparator intervention. These design features matter when interpreting changes in repeated scores: without a concurrent control group and masking, the posted record cannot isolate treatment-related change from other influences on assessment results.
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: Exclusion criteria included newly diagnosed AD, pacemaker placement, a history of implanted metal object, seizures or epilepsy, a recent history of migraines, uncontrolled depression and those on medications lowering the seizure threshold.
Overall Study
| Stage | rTMS |
|---|---|
| STARTED | 12 |
| COMPLETED | 12 |
| NOT COMPLETED | 0 |
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 | rTMS |
|---|---|---|
| Participants analysed | 12 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 3 |
| Age, Categorical: >=65 years | Participants | 9 |
| Age, Continuous | years | 73.1 (SD 7.9) |
| Sex: Female, Male: Female | Participants | 5 |
| Sex: Female, Male: Male | Participants | 7 |
| Region of Enrollment: United States | participants | 12 |
6. Primary Endpoint
The registry lists the primary outcome as Cognitive Assessment Task Scores Before, During and After rTMS., measured over 6 weeks.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | units on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is cognitive assessment task scores measured before, during, and after rTMS. It includes the Boston Diagnostic Aphasia Examination (BDAE), CFL Category naming (CFL), and Mini-Mental State Examination (MMSE). The registry describes the outcome unit as units on a scale, the summary parameter as a mean, and the dispersion as a full range. It states that higher scores are associated with better cognition and that no absolute cut-offs were used because outcomes were not assessed categorically.
These measures serve different roles in describing language-related performance and broader cognition. Naming and verbal fluency are relevant to the study's stated focus on expressive language, while the MMSE is a broader cognitive assessment. Repeated assessment can describe how scores vary across the study's evaluation periods. That makes the time points relevant to the study question, but does not itself establish why a score changed.
The record lists possible score ranges of 0 to 15 for BDAE, 0 to 62 for CFL, and 0 to 30 for MMSE. It says the full-range data and means presented are for the assessment 4 weeks after rTMS treatments. However, the actual scores, ranges, and means are not reported in the registry record available for this analysis. Nor does the record report a quantified change from baseline, a confidence interval, or a statistical test. The endpoint description therefore explains what was intended to be measured, but does not provide the numerical results needed to judge the size or precision of any change.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies an open-label study of rTMS in patients with Alzheimer's disease and describes repeated cognitive assessments. It does not report the actual BDAE, CFL, or MMSE results. As a result, the posted information does not show whether scores increased, decreased, or remained similar over the assessment periods. It also does not provide an estimate of the magnitude or precision of any change.
The primary outcome description says that higher scores are associated with better cognition. That direction helps explain how a score would ordinarily be read, but it cannot substitute for the missing observed values. No score-based conclusion about participants' performance can be drawn from the outcome definition alone. The record also says that no absolute cut-offs were used, so the stated outcomes are continuous scale scores rather than classifications into categories.
Even if within-group results were available, this design would need cautious interpretation. A single-group study has no concurrent comparison arm. Repeated assessment can reveal changes over time, but the design cannot by itself distinguish an effect of stimulation from practice effects, natural variation, changes in participants' condition, or other influences. Open-label conduct also means the study was not masked; the registry record does not report procedures intended to conceal treatment assignment during assessments.
The record lists one primary outcome measure and zero analyses. It does not report a treatment-effect estimate, a confidence interval, a p-value, an adjustment method, or a statistical model. Consequently, there is no reported inferential analysis from which to assess statistical uncertainty or evidence against a no-change hypothesis. The fact that an outcome was registered does not mean that its results were posted.
The record reports no serious adverse events and no other adverse events in the rTMS group, with 12 at risk for each category. These counts describe what the registry reports; they do not establish that every possible adverse event was assessed or that no unreported events occurred. Deaths are not reported in the registry record. Safety counts should also be read in light of the small study enrollment and the absence of a comparison group, without converting the observations into a general safety conclusion.
Overall, the record documents the study question, design, planned assessments, and reported event counts, but it does not contain the outcome data or analyses needed to quantify a language or cognitive result. It therefore supports a description of what the study set out to examine, not a conclusion about the size, direction, or reliability of a treatment effect.
9. Statistical Methods Explained
The registry classifies the study as single-group, open-label, and phase 2. These are design descriptions, not results. A single-group study observes participants receiving the intervention without a concurrent control group. An open-label study is not masked, so participants and study personnel are not described as unaware of the intervention. Here masking is listed as none. The record does not report additional procedures for reducing observer or assessment bias.
What can repeated measurements show?
Repeated measures record an outcome at more than one time point for the same study group. They can describe the sequence of scores over time and may show whether observed values differ between assessments. But a before-and-after pattern is not, by itself, a controlled estimate of an intervention effect. A score can change for reasons other than the intervention, and repeating the same or similar tasks can influence later performance. A concurrent control group can help distinguish some changes associated with receiving an intervention from changes that also occur without it; this study has no such group in the registry record.
What does a mean and full range describe?
The registered summary parameter is a mean, with full range as the dispersion measure. A mean describes the average score in the observed group, while a full range describes the lowest and highest observed values. The range gives a sense of the spread between the extremes, but it does not show how observations are distributed between them. It can also be affected by particularly low or high values. A mean and range alone do not show the uncertainty around an estimated average as directly as a confidence interval would. No actual means or ranges are reported in the registry record for interpretation.
What would a confidence interval add?
In general, a confidence interval expresses the statistical uncertainty around an estimate under the assumptions of the analysis. A relatively narrow interval indicates greater precision than a wider interval, while the interval's location indicates which values remain compatible with the data and method. It is not a guarantee that the true value lies within a particular interval. The registry record does not report confidence intervals for the outcome, nor does it report an estimate to which an interval could be attached.
What is missing from the inferential analysis?
The record lists zero analyses. It does not report a model for repeated scores, a hypothesis test, a p-value, a standard error, a confidence interval, or an approach to handling multiple outcome measures or time points. Without those details and the observed data, statistical significance and precision cannot be assessed. It would be inappropriate to infer a statistical plan from the study title, the assessment schedule, or the fact that this is a phase 2 study. The analysis plan is not reported in the registry record.
How should a sample-size illustration be understood?
In general, a sample-size calculation describes how many participants a future study might require under specified assumptions about the effect to detect, variability, significance level, and power. It is a planning exercise, not a measurement of how much power the completed study actually had. The registry's planning assumptions describe an illustration based on a fraction of an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Those assumptions do not make this single-group study a two-arm comparison, and they do not supply an observed outcome result. No sample-size justification for the original study is reported in the registry record. Any planning figures should therefore be interpreted as hypothetical illustrations, not as observed power or as evidence of treatment effect.
Why can over-dispersion matter?
In general, over-dispersion occurs when observed variability is greater than a statistical model assumes. When that happens, a model that treats the data as less variable can understate uncertainty and make estimates appear more precise than warranted. The relevance of over-dispersion depends on the outcome and analysis model. The registry record does not report a fitted model or evidence that over-dispersion was assessed, so it cannot be said whether this issue arose in this study.
These general concepts explain what different summaries and methods can contribute, but they do not fill gaps in the recorded results. The registered score definitions and design do not reveal the actual participant-level observations, the analysis choices, or the uncertainty of any treatment-related change.
10. Multiplicity, Missing Data and Analysis Populations
The registry record identifies one primary outcome measure, but that outcome includes three named assessments: BDAE, CFL Category naming, and MMSE. It also refers to measurements before, during, and after rTMS. Considering multiple measures and assessment times can raise a multiplicity issue: the more comparisons examined, the greater the opportunity for apparently notable findings to occur by chance when many tests are considered. Statistical approaches can address multiplicity, but the registry record does not report whether any correction, prioritization, or prespecified contrast was used.
The record reports zero analyses and does not provide results for the individual tests or time points. It also does not state which score or time comparison would be treated as the principal inferential test. The registered outcome title names scores before, during, and after treatment, while the description identifies the post-treatment score at 4 weeks; the record does not provide a full analysis schedule or clarify how these time points relate to the 6-week timeframe.
Missing-data methods and analysis populations are not reported in the registry record. The record does not say whether all enrolled participants completed every assessment, how incomplete scores were handled, or whether an intention-to-treat, completer, or other analysis population was used. Without such information, the completeness and representativeness of any outcome summary cannot be assessed. No assumptions about missing observations or statistical methods for handling them should be inferred from the study design alone.
The registry enrollment is 12, but it does not report the number contributing data to each assessment. Thus, the enrollment figure should not be treated as proof that every scheduled measurement was available for analysis. The absence of reported analyses and missing-data details limits assessment of both possible multiplicity and possible selection introduced by incomplete outcome data.
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 |
|---|---|---|---|
| rTMS | 0 | 12 | 0.0% |
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 |
|---|---|
| rTMS | 0 of 12 |
The registry reports zero serious adverse events and zero other adverse events for the rTMS group. It lists 12 at risk for each category. These are the event counts recorded for this study, not a complete description of every symptom, event definition, or monitoring procedure. The registry does not list serious adverse-event terms, and deaths are not reported in the registry record.
Zero reported events should be read narrowly: the posted record contains no events in these reported categories. It does not prove that no symptoms occurred, that all events were captured, or that the intervention is free of risk. The record does not provide further detail on how events were collected, how long participants were followed for safety, or how severity and relatedness were assessed.
The study is single-group and has no comparator, so its safety counts do not provide a comparative estimate. The small enrollment also limits how much can be learned from the absence of recorded events about uncommon harms. These figures are descriptive registry entries rather than a statistical demonstration of safety.
12. What the Result Does, and Does Not, Mean
The record establishes that a phase 2, open-label, single-group study examined repetitive transcranial magnetic stimulation in patients with Alzheimer's disease. It identifies language-related and broader cognitive assessments, including BDAE, CFL Category naming, and MMSE, administered before, during, and after treatment. It also describes bilateral stimulation over the right and left dorsolateral prefrontal cortex and reports 4 sessions over 2 weeks.
What the record does not establish is the direction or size of any change in cognitive scores. Actual outcome values, score ranges, means, and analyses are not reported in the registry record. There is no reported effect estimate, confidence interval, p-value, or model. As a result, neither the statistical precision of an outcome nor the degree to which observed scores may have changed can be assessed from these entries.
The design also limits causal interpretation. With no concurrent control group, changes over time cannot be cleanly attributed to rTMS. Repeated testing, natural variation, and other influences could contribute to score patterns. Open-label conduct leaves the study unmasked, and the record does not describe procedures that would address potential influence on assessment or reporting.
The absence of reported adverse events is likewise a limited observation, not a general assurance about safety. The registry lists zero serious and zero other adverse events, but deaths are not reported and details of safety monitoring are not given. The record does not allow conclusions about uncommon events or comparisons with another treatment.
Accordingly, the study record is informative about the question asked and the broad design used, but it does not provide posted results sufficient to judge efficacy, precision, or comparative safety. The absence of outcome results is not evidence that there was no change; it means that the registry record does not report the information needed to determine what happened to the measured scores.
13. Why This Trial Matters Statistically
This trial is statistically informative in part because its design makes the distinction between observing change and estimating a treatment effect especially important. Repeated cognitive assessments can describe score patterns over time. However, without a concurrent comparator, those patterns do not isolate the effect of rTMS from practice, natural fluctuation, or other changes occurring during the study. A clearly described outcome and assessment schedule are useful, but they do not replace a design that supports causal comparison.
The registry also highlights why outcome descriptions and outcome results must be distinguished. It identifies named language and cognition measures, their score direction, and their possible ranges, but does not report the measured values or analyses. Readers can understand what investigators intended to measure, yet cannot assess the result's magnitude, variability, or uncertainty. A registered endpoint is not itself a finding.
Multiplicity is another relevant statistical concern. The outcome includes multiple assessments and time points, and the record does not state how these were prioritized or analyzed. Without an analysis plan or posted analyses, it is not possible to determine whether any reported comparison was prespecified or how uncertainty across multiple comparisons would be addressed.
Finally, the study illustrates the difference between planning calculations and evidence from observed data. Sample-size illustrations based on an assumed fraction of an observed effect are hypothetical planning tools. They do not establish that the completed study had adequate power, and they cannot replace an estimate with an uncertainty interval. Here, the registry record does not report the outcome estimates needed for that interpretation.
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.
Several trial-specific limitations constrain interpretation. The study has a single group and no concurrent control condition, so any score change cannot be separated from other influences over time. Its open-label status means masking was absent. The registry does not report whether assessors were otherwise kept unaware of treatment timing or whether other bias-reduction measures were used.
Although the record describes bilateral stimulation and 4 sessions over 2 weeks, the arm description is incomplete. Further intervention details are not reported in the registry record. The exact timing of each assessment is also unclear: the primary timeframe is listed as 6 weeks, while the description identifies a post-treatment assessment 4 weeks after rTMS. The record does not explain the relationship between these timing statements.
The primary outcome combines three named assessments, but no individual scores, means, full ranges, or analysis results are reported. The record also does not explain how multiple measures and time points were handled. Missing-data methods and the number of participants contributing to each assessment are not reported. These omissions prevent assessment of outcome completeness and the potential influence of missing observations.
The enrollment is 12, and the record provides no sample-size justification for the original study. It does not report the statistical plan, a model for repeated measures, a confidence interval, or a hypothesis test. The status is completed, but completion does not mean that outcome results are available in the registry record. These limitations make it impossible to quantify the study's cognitive findings or their uncertainty from the posted information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Effect of Repetitive Transcranial Magnetic Stimulation on Language in Alzheimer's Disease — NCT00814697.
- Registry record last updated 2014-01-28; status last verified 2014-01.
- Results first posted 2014-01-28.
- 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
NCT00814697 is a completed phase 2, open-label, single-group study sponsored by The New York Memory Services. The registry lists an enrollment of 12, a start date of 2008-12, and primary completion in 2011-12. The study examined repetitive transcranial magnetic coil stimulation in patients with Alzheimer's disease, with bilateral stimulation over the right and left dorsolateral prefrontal cortex.
The primary outcome concerns BDAE, CFL Category naming, and MMSE scores before, during, and after treatment. The registry describes higher scores as associated with better cognition and specifies means and full ranges, but the actual outcome results and analyses are not reported in the registry record. The record lists zero serious and zero other adverse events; deaths are not reported. With no comparator and no posted score analysis, the registry supports a description of the study design and recorded safety counts, but not an estimate of treatment effect.