InformationSeekingMesolimbicEngagementStudy1: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for InformationSeekingMesolimbicEngagementStudy1 (NCT06257446), a na na study. The primary outcome is Mesolimbic-hippocampal Interactions.

2. Clinical Question

3. Trial Design

NCT06257446 is titled InformationSeekingMesolimbicEngagementStudy1, with the official title “The Influence of Mesolimbic-hippocampal Interactions on Episodic Memory During Active Information Seeking.” The registry lists Motivation as the condition and Task Instructions as a behavioral intervention. The brief summary describes a novel Game Show task intended to manipulate participants’ agency over their learning environment and specify unguided exploration.

The design is recorded as single group, with allocation listed as NA and masking as NONE. The arm description clarifies that agency and no-agency trials are compared within the same participants. This is therefore a within-subjects comparison, not a comparison between separately allocated intervention and control groups. The record does not report random assignment of trial types, the sequence of conditions, or whether the order was counterbalanced. Those design details should not be assumed.

The registry records enrollment as 76 and status as COMPLETED. The recorded study start date is 2023-10-25, and the primary completion date is 2024-02-09. These administrative details describe the registered study; they do not establish how many participants contributed usable data to the primary analysis. The primary outcome description refers to the population that continued the protocol, but a detailed analysis-population definition and accounting of exclusions are not reported in the registry record.

The record lists two outcome measures and two analyses, but it does not provide the corresponding estimates, uncertainty measures, or analysis-specific participant counts. The study is not a randomized clinical treatment comparison. Its stated focus is the relationship between active information seeking, episodic memory, and activity patterns in specified brain regions during a task. Conclusions should therefore remain within that research context.

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: Of the 76 participants that were recruiteted, 0 were excluded prior to assignment.

Overall Study

Analysis population for the primary outcome, as defined in the registry: This is the entire population that continued the protocol. While in typical clinical trials there may be a comparison across arms of a group, this study utilized a within-subjects design, thus we were comparing conditions within one group of participants. In this way, our overall participant pool reflects a single arm and our statistical comparisons were made across conditions within this single group.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Mesolimbic-hippocampal Interactions, measured over During Procedure.

The primary endpoint is titled Mesolimbic-hippocampal Interactions. It is described as functional magnetic resonance imaging activation characterizing interactions between mesolimbic and hippocampal regions of interest during the procedure. The analysis examines pattern similarity within the same set of regions across different trial types. The registry says the resulting value is a correlation summarized as a standardized beta-value extracted from a nested mixed effects model. The measure is continuous, and the stated unit is standardized beta-value.

In general, a measure of pattern similarity can capture how similar the measured activity patterns are across conditions or trial types. It can offer a quantitative way to study whether activity in specified regions varies with task context. A standardized beta-value expresses a model-based association on a standardized scale; it is not, by itself, a direct measure of a participant’s memory performance or a clinical outcome.

The endpoint is relevant to the study’s stated interest in mesolimbic-hippocampal interactions during active information seeking. The registry lists the timeframe as During Procedure and gives Standard Error as the dispersion measure. However, it does not report the endpoint’s observed mean or contrast, the standard error value, or a confidence interval. The endpoint’s rationale and measurement description are available, but the magnitude and precision of the posted result are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is continuous: its stated unit is a standardized beta-value, and the registry identifies the summary parameter as a mean. The measure is derived from an analysis of functional MRI pattern similarity in mesolimbic and hippocampal regions. The registry describes the beta-value as coming from a nested mixed effects model and reports Standard Error as the measure of dispersion. These details indicate the intended form of the outcome and its summary, but the model’s full specification and its numerical estimates are not reported in the registry record.

What does a mean describe?

In general, a mean describes the central value of a set of observations. For a continuous measure, it can offer a concise summary, but it does not show the full spread or shape of the observations. In a within-subjects design, a condition comparison may be based on paired observations or a model that accounts for observations clustered within participants. The registry identifies the study as within-subjects, but does not specify the exact contrast calculation or how repeated trial-level data were handled. Therefore, readers should not infer those details from the phrase “single group” alone.

What does the standard error convey?

In general, a standard error describes the statistical uncertainty around an estimated quantity, rather than the variability among individual observations. A smaller standard error relative to an estimate indicates greater precision under the assumptions of the analysis; a larger one indicates less precision. A confidence interval uses an estimate and its standard error, together with a specified method, to express a range of values compatible with the data and model. The registry identifies Standard Error as the dispersion measure, but does not report its value or a confidence interval for the primary endpoint. Precision therefore cannot be judged from the record.

Why does the model matter?

The registry describes the endpoint as a correlation summarized by a standardized beta-value extracted from a nested mixed effects model. In general, mixed effects models can represent both systematic differences associated with predictors and variation linked to clusters or repeated measurements. This can be useful when observations are not independent, as may occur when multiple trials come from the same participant. “Nested” indicates a structured model, but the record does not describe its levels, random effects, fixed effects, covariance assumptions, estimation method, or diagnostics. It is not possible to determine from the description alone whether the chosen structure appropriately reflects the data.

Standardization can make a model coefficient easier to compare across measures expressed on different scales, but it does not remove the need to understand what was standardized or how. The registry does not specify the standardization procedure, the scale used for the underlying correlation, or the exact interpretation of a one-unit change in the reported beta-value. The listed unit should therefore be read as the registry’s stated reporting scale, not as a direct clinical quantity.

How should a condition contrast be read?

In general, a within-subjects contrast compares measurements from conditions experienced by the same participants. Pairing can account for stable participant-level differences, but the interpretation also depends on the order and implementation of conditions, the handling of repeated trials, and the model used. If trial conditions are not assigned or ordered in a way that controls relevant sources of bias, a contrast may reflect more than the intended agency manipulation. The registry does not report the condition order, randomization at the trial level, counterbalancing, or related safeguards. These cannot be assumed.

The record says there are two outcome measures and two analyses, but does not identify all corresponding tests or state how they relate to the primary endpoint. A statistical analysis plan, prespecified contrasts, and adjustments for multiple testing are not reported in the registry record. Without those details, readers cannot assess whether the reported analysis followed a prespecified hierarchy or how the chance of false-positive findings across analyses was addressed.

What can be concluded from the available reporting?

Statistical interpretation requires an estimate as well as a description of the method. The registry supplies the endpoint concept, unit, summary parameter, dispersion type, and timeframe, but not the mean, contrast estimate, standard error value, confidence interval, or p-value. No conclusion about the observed direction, magnitude, or precision is supported by the numerical results in the record. The completed status and enrollment count do not substitute for those estimates.

A sample-size illustration, if considered alongside the registry, is a planning exercise rather than an observed result. The stated assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect expressed as a fraction of the observed effect. Those assumptions do not describe the actual single-group within-subjects design as recorded. Any such illustration should not be interpreted as the study’s design justification or as observed power. The registry does not report the study’s own sample-size justification.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures and two analyses, but does not report a multiplicity strategy. In general, when investigators evaluate multiple outcomes or contrasts, the chance of at least one false-positive result can increase if each is assessed without accounting for the others. Common approaches include specifying a primary outcome in advance, arranging tests in a hierarchy, or adjusting inference across a family of tests. The registry record does not state whether any such approach was planned or used. The number of listed outcomes and analyses alone does not establish how they were treated.

Missing-data handling is not reported in the registry record. This includes whether missing imaging or task observations occurred, how incomplete participants or trials were treated, and whether any imputation or other method was used. These details matter because the analysis population and the pattern of missing observations can affect both the estimate and its uncertainty. The primary outcome description refers to the population that continued the protocol, but it does not give a detailed definition or participant flow for the analysis.

The record does not state whether the primary analysis followed an intention-to-treat principle, a per-protocol definition, or another analysis-population rule. Such labels should not be inferred for this task-based study. Without clear population counts, exclusions, and missing-data procedures, the reader cannot assess how closely the analyzed data represent the enrollment recorded in the registry.

11. 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.

The registry reports zero serious adverse events among 74 participants at risk in the Motivation group. It also reports zero other adverse events among 74 at risk and zero deaths. These are the safety counts recorded for that group. The enrollment entry is 76, while the adverse-event denominator is 74; the registry record does not explain the difference, so the counts should not be treated as covering every enrolled participant.

In general, an adverse-event count is interpreted in relation to the population monitored, the event definitions, and the observation period. The registry does not provide the monitoring duration, event-collection procedures, or detailed definitions for serious and other events. Zero recorded events in these entries means that no events of those categories are reported for the listed at-risk group; it does not establish that no event occurred outside the recorded scope or that the task has been demonstrated to be risk-free. These safety figures do not indicate the direction or precision of the primary imaging result.

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

The registry record describes a completed research study using a Game Show task to examine agency during learning and mesolimbic-hippocampal activity associated with episodic memory. Its primary endpoint is a continuous, model-derived standardized beta-value representing pattern similarity across trial types in specified brain regions. The design compares agency and no-agency trials within one group of participants. This gives readers the study’s central question and the intended type of measurement.

What the record does not establish is the observed result. It does not report the primary endpoint estimate, the contrast between conditions, the standard error value, a confidence interval, or a p-value. Thus the posted information does not show whether the measure differed by condition, in which direction it differed, or how precisely a difference was estimated. No conclusion about the size or statistical significance of the primary result can be drawn from the record.

Even if an imaging contrast were reported, a standardized beta-value would describe a model-based statistical measure, not by itself a direct improvement or impairment in episodic memory. The registry’s outcome description connects the measure to activity patterns and interactions across regions, but it does not give a numerical memory-performance result or an estimate of a relationship between memory performance and the imaging endpoint. Those conclusions should not be inferred.

The study is also not a clinical treatment trial comparing an assigned intervention with a separate control group. It is a within-subjects task study, and its findings, if fully reported, would need to be interpreted in relation to the task, measurement, analysis model, and participants who contributed data. The registry does not report enough analysis detail to evaluate those considerations fully. The completed status, enrollment entry, and adverse-event counts are useful record details, but they cannot replace the missing primary outcome estimates.

13. Why This Trial Matters Statistically

This study is statistically notable for using a within-subjects task design to investigate a question about active information seeking and brain activity. Comparing conditions within participants can, in general, reduce the influence of stable differences between people. At the same time, it makes the interpretation dependent on how trials and repeated measurements are organized and modeled. The registry’s description of a nested mixed effects model signals that the endpoint is intended to be a model-based summary of patterned activity, rather than a simple count or direct clinical measure.

The study also illustrates why endpoint definition and outcome reporting are both necessary. The registry gives a specific imaging endpoint, its stated unit, the general analysis concept, and the timeframe. That is useful for understanding what investigators intended to measure. Yet without the numerical estimate and uncertainty, a reader cannot judge the observed pattern or distinguish a precise estimate from an uncertain one. A clearly described endpoint does not by itself communicate the evidence about the result.

Finally, the record highlights the importance of transparent reporting for secondary outcomes, analysis populations, missing data, and multiplicity. It lists two outcomes and two analyses, but does not report the results or the methods used to handle those issues. Such details help readers understand how a result was obtained and how broadly it should be interpreted. The statistical value of the registry record is therefore primarily in its description of the research question and design; numerical outcome reporting would be needed to assess the findings.

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 design and reporting details needed for a fuller assessment are not reported in the registry record. Although the study is described as within-subjects, the record does not state how agency and no-agency trials were ordered, whether trial assignment was randomized, or whether condition order was counterbalanced. These details can matter when task performance or measured activity may change over time or with exposure to the task.

The primary endpoint description gives the broad model approach but not the complete model specification. The record does not state the fixed and random effects, how observations were nested, how the correlation was calculated, what covariates were included, or what diagnostics were used. The exact contrast and the standardization procedure are also not reported. Consequently, readers cannot independently assess whether the model structure and reported scale align with the intended scientific question.

The registry records enrollment as 76, while safety counts use 74 participants at risk. It does not provide a participant flow or explain the analysis denominator for the primary endpoint. The population description is incomplete in the registry record, and exclusions, incomplete imaging data, and missing-data methods are not reported. The record also does not provide estimates for the primary outcome or the other listed outcome measures, preventing assessment of result magnitude and precision.

Finally, the study’s allocation is listed as NA and masking as NONE. The record does not describe a separate comparator group, and it does not provide a statistical plan, multiplicity strategy, or sample-size justification. These limitations concern what can be assessed from the registry record; they do not establish that the study lacked procedures that were not registered or reported.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: InformationSeekingMesolimbicEngagementStudy1 — NCT06257446.
• Registry record last updated 2026-04-23; status last verified 2026-04.
• Results first posted 2026-04-23.
• 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.

18. Record Summary

NCT06257446 is a completed, single-group study titled InformationSeekingMesolimbicEngagementStudy1. It examines agency during a Game Show learning task and mesolimbic-hippocampal interactions during the procedure. The design compares agency and no-agency trials within participants; allocation is listed as NA and masking as NONE. The registry records enrollment as 76 and identifies Task Instructions as a behavioral intervention.

The primary endpoint is a continuous standardized beta-value derived from a nested mixed effects model of functional MRI pattern similarity. The record lists Standard Error as the dispersion measure. It does not report the primary estimate, its uncertainty value, or a condition contrast. It also does not report detailed analysis-population rules, missing-data methods, or multiplicity handling. Safety entries list zero serious adverse events, zero other adverse events, and zero deaths among 74 participants at risk. These entries do not provide evidence about the unreported primary outcome estimate.