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 Memory Training in Aneurysmal Subarachnoid Hemorrhage Patients (NCT02864940), a randomized na study. The primary outcome is CLCE-24.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02864940 |
| Phase | NA |
| Condition | Ruptured Aneurysm, Memory Deficits, Subarachnoid Hemorrhage |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 38 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Rush University Medical Center |
| Results posted | Yes |
2. Clinical Question
Population
Patients with ruptured cerebral aneurysms and disabling baseline memory deficits, within the first 24 months after rupture. The registry record describes this target population but does not provide further eligibility details.
Intervention
Online cognitive exercises designed by Lumosity, used for 10 weeks.
Comparator
Online crossword puzzles used for 10 weeks as an active control.
Primary question
At one year, what CLCE-24 cognitive and emotional complaint scores were reported for participants assigned to Lumosity exercises compared with participants assigned to crossword puzzles?
The study aim was to determine whether periodic online cognitive exercises improve memory function in patients with ruptured cerebral aneurysms and disabling baseline memory deficits. The primary measure, however, captures a broader set of cognitive complaints, including concerns related to memory, attention, executive functioning, processing speed and visuospatial perception. It is therefore important to distinguish the study’s stated interest in memory function from the scope of the registered primary measure.
The comparison is between two online activities rather than between cognitive exercises and no activity. Both groups were assigned a 10-week program, so the registered comparison concerns the Lumosity program relative to crossword puzzles. The registry record reports CLCE-24 scores at one year and describes only 7 participants in each arm as having participated in the games and completed their post-assessment. The record does not establish what happened to other enrolled participants or provide a complete analysis of the intended study population.
3. Trial Design
This was a randomized, parallel-group trial with no masking. The registry record lists an enrollment of 38 and identifies the study status as terminated. It gives a study start of 2016-06 and a primary completion date of 2018-08-15. The reason for termination is not reported in the registry record.
Participants were assigned to one of two online activities. The intervention arm used Lumosity cognitive exercises for 10 weeks; the control arm used online crossword puzzles for 10 weeks. The study summary describes the crossword activity as an active control. The registry record does not provide details about how randomization was generated or implemented, whether allocation was concealed, how often participants were expected to use the activities, or how adherence was assessed.
The registered primary outcome was CLCE-24 score at one year. The record says that only 7 participants in the control arm and 7 participants in the intervention arm participated in the games and completed their post-assessment. These are the groups for which the posted primary outcome values are reported. The record does not explain the relationship between this limited assessment participation and the enrollment figure, or describe the disposition of other enrolled participants.
No masking was used. The record does not say whether outcome interviewers were masked to assignment. It lists 3 outcome measures and no posted secondary outcomes, but it does not provide a complete account of the intended analysis population, analysis methods, or reasons for termination. The study’s statistical plan and any 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
| Stage | Intervention Arm | Control Arm |
|---|---|---|
| STARTED | 20 | 18 |
| COMPLETED | 7 | 7 |
| NOT COMPLETED | 13 | 11 |
Reasons for not completing this period:
| Reason | Intervention Arm | Control Arm |
|---|---|---|
| Never took part in intervention or control arm activities or completed post assessments | 13 | 11 |
Analysis population for the primary outcome, as defined in the registry: only 7 subjects in the control arm and 7 subject in the intervention arm participated in the games and completed their post assessment.
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: 18 subjects in the control arm completed the pre-intervention assessments for CLCE-24, working memory and Activities of daily living. 20 subjects in the Intervention arm completed the pre-intervention assessments for CLCE-24, and Activities of daily living. 19 subjects completed the working memory assessment.
| Characteristic | Unit | Control Arm | Intervention Arm | Total |
|---|---|---|---|---|
| Participants analysed | 18 | 20 | 38 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 16 | 19 | 35 |
| Age, Categorical: >=65 years | Participants | 2 | 1 | 3 |
| Sex: Female, Male: Female | Participants | — | — | 0 |
| Sex: Female, Male: Male | Participants | — | — | 0 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| CLCE-24 | Number of complaints | 13.7 (8 to 21) | 12.1 (7 to 21) | 12.9 (7 to 21) |
| Working memory | Units on a Scale | 36.17 (8 to 79) | 38 (12.5 to 85) | 37 (8 to 85) |
| Activity of Daily Living | percentage of impairment | 32 (6 to 82) | 23 (6.6 to 55.5) | 27.5 (6 to 82) |
6. Primary Endpoint
The registry lists the primary outcome as CLCE-24, measured over One year.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | score on scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the Cognitive and Emotional Consequences CLCE-24-C score, recorded as a score on a scale at one year. Its 13 items address cognitive complaints, with examples including difficulty doing two things at once or remembering new information. The items cover executive functioning, attention, memory, speed of processing and visuospatial perception. The measure is intended to capture complaints experienced by the patient, rather than performance on a single memory task.
An interviewer scores each item as 0 for no complaint, 1 for a possible complaint or 2 for a complaint being present. Total scores range from 0-26, with higher scores indicating more cognitive complaints. In this context, a lower score represents fewer reported complaints on the scale; it does not by itself establish a change in objective cognitive ability or isolate memory from the other domains.
The posted outcome values are described as means, with full ranges reported for each arm. The registry record gives a mean of 12.6 and a range of 9.0-14.0 for the control arm, and a mean of 10.4 and a range of 7.0-15.0 for the intervention arm. The endpoint is relevant to the study’s broader concern about cognitive complaints after hemorrhage, but interpretation should account for the limited number of participants with reported post-assessments and the absence of an inferential comparison in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome consists of a mean CLCE-24 score and a full range for each arm at one year. The control arm’s reported mean is 12.6, with a range of 9.0-14.0. The intervention arm’s reported mean is 10.4, with a range of 7.0-15.0. The numerical ordering is consistent with a lower average complaint score in the intervention arm, while the reported ranges overlap. These descriptive statistics alone do not establish whether the observed pattern reflects a reliable difference between assigned activities.
Only 7 participants in each arm are described as having participated in the games and completed their post-assessment. That limited assessment group is central to interpreting the results. The record does not explain why other enrolled participants are not represented in the posted primary outcome, whether their outcomes were unavailable, or how their absence was handled. Consequently, the reported arm summaries cannot be assumed to represent all randomized participants.
No statistical analyses are posted in the registry record. There is no reported estimate of the between-arm comparison, confidence interval, hypothesis test or adjustment for baseline score. The posted means and ranges therefore describe the outcome data but do not quantify the uncertainty around a treatment contrast. It is not possible from these summaries alone to distinguish a meaningful underlying difference from variation that could occur in a small assessed group.
The full range is a description of the lowest and highest reported values, not a confidence interval. It conveys the observed spread but does not show how precisely the mean estimates the population mean. Because no other measure of dispersion is posted, the degree of variation around the group means cannot be characterized with a standard deviation or standard error from the registry record.
The trial was unmasked, and the endpoint reflects complaints elicited and scored in an interview. In general, knowledge of assignment can influence participant reports or outcome assessment; the registry record does not say whether interviewers were masked. This is a potential interpretation concern, not evidence that assessment bias occurred. The registry status is terminated, but the reason is not reported, so termination should not be attributed to the outcome pattern or to any specific operational issue.
Overall, the record supports a descriptive account of scores among the participants with reported post-assessments. It does not provide enough statistical detail to make a supported claim about the comparative effect of the two activities, and it does not establish that the observed summaries apply to the full enrolled population.
9. Statistical Methods Explained
The available statistical information is descriptive. The primary measure is reported as a mean score with a full range in each arm. There are no posted analyses, no reported estimate of the between-arm contrast and no reported confidence interval or hypothesis-test result. This means the registry record allows readers to examine the reported group summaries but not to assess a formally estimated comparative effect.
What does a mean describe?
In general, a mean is an average that combines the observations in a group into one summary. It can be useful for comparing groups, but it does not show the individual scores or how tightly they cluster. A mean can be affected by unusually low or high values, particularly when the group being summarized is small. Here, the reported means are 12.6 for control and 10.4 for intervention. The record does not give enough information to calculate the uncertainty around either mean or around their contrast.
The CLCE-24 score has a defined bounded range of 0-26, with higher scores indicating more complaints. A bounded scale can still have a distribution that is uneven, concentrated at particular values, or otherwise different from the assumptions of a statistical model. The registry record does not provide individual scores or a distribution plot, so the shape of the score distribution cannot be evaluated from the reported summaries.
What does the full range tell us?
In general, the full range gives the smallest and largest observed values in a group. The control range is 9.0-14.0 and the intervention range is 7.0-15.0. A range is sensitive to the most extreme observations and does not describe the spread of the other values in between. It also does not quantify the precision of a mean. A confidence interval serves a different purpose: it expresses uncertainty about an estimated quantity under the analysis assumptions. No confidence interval is reported for this outcome.
The outcome description identifies the dispersion as a full range; no standard deviation or standard error is posted. Without an appropriate estimate of variability and the participant-level data, readers cannot derive a valid confidence interval or standard error from these summaries alone. Reconstructing an inferential comparison from the mean and range would require assumptions that are not established in the registry record.
Why does the assessed group matter?
The record describes only 7 participants in each arm as having participated in the games and completed their post-assessment. The enrollment figure is 38, but the record does not explain the status or outcome availability of the remaining enrolled participants. In general, outcomes observed only for a subset of assigned participants may not represent outcomes for everyone randomized, especially if availability of follow-up is related to health, engagement, assignment or the outcome itself. Whether any such relationship occurred in this study is not reported.
A complete analysis plan would explain which participants were included, how missing outcomes were handled, and whether the primary comparison followed original random assignment. Those details are not reported in the registry record. Without them, the descriptive summaries should be understood as applying to the participants for whom post-assessment results are reported, rather than automatically to the full randomized study population.
What can randomization and masking contribute?
Randomization is intended, in general, to make assigned groups comparable in expectation, including for factors not measured by investigators. It does not guarantee that groups will be similar in every characteristic in a particular trial. With limited assessment participation, observed group summaries may also be affected by which participants have available outcomes. The registry record confirms randomized allocation but does not report baseline summaries or an adjusted analysis that would help readers assess these issues.
The study was unmasked. In general, masking can reduce the influence of knowledge of assignment on reported outcomes, assessment, or decisions about data handling. Because the endpoint is based on complaints recorded by an interviewer, it matters whether the assessor knew participants’ assignments; that detail is not reported. No specific bias can be inferred from the absence of masking alone.
What do the planning assumptions mean?
The registry record describes a planning illustration based on the observed effect, with equal allocation between arms, a two-sided significance level of 0.05 and a normal approximation. It also describes detecting a stated fraction of the observed effect. Such calculations concern hypothetical future study planning, not the probability that this completed trial found a real effect. They are not observed power, and they do not replace an analysis of the posted outcomes. The registry record does not report the study’s own sample-size justification or a statistical analysis plan.
In general, over-dispersion means that outcome variability is greater than a model assumes. When present, it can make conventional uncertainty estimates too narrow and tests too optimistic unless the analysis accounts for it. The record provides no model-based analysis or distributional information that would permit assessment of over-dispersion for this endpoint. More broadly, the reported means and ranges are not enough to reconstruct the sponsor’s intended analysis. The registry record contains no posted analysis to compare with any recalculation.
10. Multiplicity, Missing Data and Analysis Populations
The registry record identifies CLCE-24 as the primary outcome and lists 3 outcome measures, but no secondary outcomes are posted. It does not report results for additional outcomes or explain how any multiple-outcome testing was planned. Multiplicity matters in general when several outcomes or comparisons are tested: examining more results can increase the chance of finding an apparently notable result by chance. No multiplicity adjustment or testing strategy is reported, so none can be assumed.
Missing outcome information is a major interpretive issue. The record says that only 7 control participants and 7 intervention participants participated in the games and completed their post-assessment. It does not report why other enrolled participants lack a posted post-assessment, whether the same reasons applied across arms, or whether missingness was related to outcome values. It also does not describe an imputation method, sensitivity analysis or other missing-data procedure.
The registry record does not specify an intention-to-treat analysis population, a per-protocol population or another analysis set. It therefore does not establish whether the primary outcome summaries include everyone assigned to an arm who had a measured endpoint, or whether additional eligibility criteria were applied. No baseline outcome values, participant-level data or adjusted comparison are posted. These omissions limit assessment of comparability, missing-data bias and the scope of the conclusions. The reason the trial was terminated is also not reported in the registry record.
11. What the Result Does, and Does Not, Mean
The posted results show the one-year CLCE-24 summaries among participants with reported post-assessments: a mean of 12.6 in the control arm and 10.4 in the intervention arm, with the ranges 9.0-14.0 and 7.0-15.0, respectively. On this scale, higher scores indicate more cognitive complaints. These figures describe the observed data in the reported assessment groups; they do not demonstrate that one activity caused a difference in complaints.
The record does not report a statistical comparison, confidence interval or hypothesis test. Readers therefore cannot use it to determine the precision of the apparent difference in means or whether the data are compatible with a range of possible underlying effects. The overlapping full ranges are descriptive and should not be treated as a test of whether the groups differ. Nor does a difference in means alone establish a clinically important change.
The endpoint covers several cognitive domains and reflects complaints captured by an interview score. It is not a direct, domain-specific test of memory performance. The study’s aim concerns memory function, but the registered measure also includes executive functioning, attention, processing speed and visuospatial perception. The reported outcome should be interpreted as a broad complaint measure, not as an isolated measure of memory improvement.
The data also have a limited reach because only 7 participants in each arm are described as having completed the post-assessment after participating in the games. The registry record does not provide an explanation of the outcomes or status of other enrolled participants. The posted values therefore cannot be taken as a complete account of outcomes for all enrolled or randomized participants.
The registry status is terminated, but the reason is not reported. The record also lists zero for the posted serious adverse events, other adverse events and deaths in each arm. Those entries describe what is recorded in those categories; they do not establish that no unrecorded events occurred. Taken together, the record gives a limited descriptive view and does not support a definitive conclusion about comparative efficacy or safety.
12. Why This Trial Matters Statistically
This trial illustrates why a registry record’s descriptive results and a statistical conclusion are not the same thing. Group means can show the direction of the observed numerical pattern, but without an estimate of uncertainty they do not show how precisely that pattern represents the underlying population. Reporting the mean alongside a full range adds information about the observed extremes, but the range cannot stand in for a confidence interval or a complete account of variability.
The record also highlights how analysis populations shape interpretation. Enrollment is reported as 38, while the primary outcome description identifies only 7 participants in each arm as having participated in the activities and completed the post-assessment. Without information about the outcomes and follow-up status of other enrolled participants, readers cannot determine how representative the observed group summaries are. This is not merely a reporting detail: missing outcomes may affect the estimated comparison if the participants with available scores differ systematically from those without them.
The endpoint itself calls for careful interpretation. The study aim focuses on memory function, while the CLCE-24 captures complaints across several cognitive domains. That measure may be pertinent to a broad account of cognitive complaints, but its scores should not be described as a specific objective memory-performance result.
Finally, the comparator is an active online activity, and the trial was unmasked. These design features shape what the comparison can address and how participant-reported complaints might be interpreted. The record does not provide enough detail to assess assessor masking, adherence, missing-data handling or the planned statistical analysis. The case demonstrates why a clear analysis plan and transparent reporting of uncertainty, participant flow and outcome availability are important for evaluating trial evidence.
13. 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 primary limitation is the small assessed group documented for the endpoint: only 7 participants in each arm are described as having participated in the games and completed post-assessment. Although enrollment is reported as 38, the registry record does not explain the disposition or outcome availability of other enrolled participants. Without that information, it is not possible to assess how selection into the assessed group may have affected the posted results.
The registry record gives means and full ranges but no standard deviations, standard errors, confidence intervals or formal comparison. It does not provide individual observations, baseline CLCE-24 scores or an adjusted analysis. As a result, variability, precision and changes from baseline cannot be evaluated using the posted outcome information. The ranges alone do not supply these missing details.
The outcome measures cognitive complaints across multiple domains, while the stated study aim emphasizes memory function. The score therefore should not be treated as a domain-specific measure of memory performance. In addition, no masking was used. The record does not say whether interviewers were masked to assignment, leaving uncertainty about how assignment knowledge may have related to assessment.
Information about adherence, missing-data procedures, analysis populations, randomization implementation and the statistical plan is not reported in the registry record. The reason for termination is also not reported. The registry lists zero adverse events in the posted categories for both arms, but the record does not provide detail on ascertainment or completeness. These limitations constrain the conclusions that can be drawn from the descriptive summaries.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Memory Training in Aneurysmal Subarachnoid Hemorrhage Patients — NCT02864940.
- Registry record last updated 2023-04-10; status last verified 2023-03.
- Results first posted 2023-04-10.
- 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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17. Record Summary
NCT02864940 is a randomized, unmasked, parallel-group study of Lumosity cognitive exercises versus online crossword puzzles in patients with ruptured cerebral aneurysms and disabling baseline memory deficits. Both activities were assigned for 10 weeks. The primary outcome is the CLCE-24 score at one year, a measure of cognitive and emotional complaints across multiple domains.
The registry reports an enrollment of 38 and a terminated status. It describes 7 participants in each arm as having participated in the activities and completed their post-assessment. The reported primary means are 12.6 for control and 10.4 for intervention; the full ranges are 9.0-14.0 and 7.0-15.0, respectively. No analyses are posted. The registry record does not report the reason for termination, the statistical plan, the handling of missing outcomes or a formal estimate of the between-arm comparison.