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 SHARPEN - Parkinson's Disease Dementia (NCT05987540), a na na study. The primary outcome is MDS-UPDRS (Sum of Parts I, II & III).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05987540 |
| Phase | NA |
| Condition | Parkinson Disease Dementia |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 9 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Scion NeuroStim |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns adults diagnosed with mild or moderate Parkinson's disease dementia. The registry lists an enrollment of 9. The primary outcome population is described as participants who completed an end-of-treatment visit or an early termination visit; the number in that population is not reported in the registry record.
Intervention
The intervention is non-invasive brainstem stimulation, described in the arm information as time-varying caloric vestibular stimulation. The study summary describes a device that remains outside the body and does not penetrate the skin. Neuromodulation is described as stimulation of brain activity.
Comparator
This is a single-group study, with no comparator group listed. Allocation is recorded as NA. Consequently, the registry record does not describe a randomized, between-group comparison or a like-for-like control comparison.
Primary question
The primary outcome is the change from baseline to Day 84 in the sum of MDS-UPDRS Parts I, II and III. The registry describes the study purpose as evaluating feasibility and safety of treatment. Although the primary measure records change in Parkinson's disease-related symptoms, the numerical outcome result is not reported in the registry record, so the magnitude and precision of any change cannot be assessed from the posted results.
3. Trial Design
SHARPEN - Parkinson's Disease Dementia is registered as NCT05987540. Its official title is Simple, Home-use Neurostimulation tReatment for Parkinson's Disease dEmeNtia. Scion NeuroStim is listed as the sponsor. The registry describes a single-group, non-randomized study, with masking recorded as NONE and allocation as NA. The phase is listed as NA.
The study summary identifies its purpose as evaluating the feasibility and safety of treatment with a non-invasive neuromodulation device in adults diagnosed with mild or moderate Parkinson's disease dementia. The intervention is listed as non-invasive brainstem stimulation, and the investigational treatment is described as time-varying caloric vestibular stimulation. No separate control treatment or comparator group is listed.
The registry records a start date of 2024-05-08, a primary completion date of 2025-02-24, and a status of TERMINATED. The reason for termination is not reported in the registry record. Enrollment is recorded as 9; this is not, by itself, a count of participants who completed treatment or contributed to the primary outcome. The outcome population is specified as participants who completed an end-of-treatment visit or an early termination visit, but the size of that population is not reported in the registry record.
The primary outcome is the change from baseline to Day 84 in the sum of MDS-UPDRS Parts I, II and III, summarized using a median and full range. Montreal Cognitive Assessment (MoCA) is listed among the secondary outcomes. The registry lists 4 outcome measures and 2 analyses, but further information about the analysis procedures is 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 | Investigational Treatment |
|---|---|
| STARTED | 9 |
| COMPLETED | 3 |
| NOT COMPLETED | 6 |
Reasons for not completing this period:
| Reason | Investigational Treatment |
|---|---|
| Withdrawal by Subject | 2 |
| Death | 1 |
| Study Termination | 1 |
| Adverse Event | 2 |
Analysis population for the primary outcome, as defined in the registry: Participants that completed an end of treatment visit or early termination visit.
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 | Investigational Treatment |
|---|---|---|
| Participants analysed | 9 | |
| Age, Continuous | years | 75 (62 to 84) |
| Sex: Female, Male: Female | Participants | 4 |
| Sex: Female, Male: Male | Participants | 5 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 9 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| 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 | 0 |
| Race (NIH/OMB): White | Participants | 9 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Montreal Cognitive Assessment (MoCA) | Total points | 18 (9 to 24) |
| MDS-UPDRS (Sum of Parts I, II, and III) | Total points | 76 (46 to 109) |
6. Primary Endpoint
The registry lists the primary outcome as MDS-UPDRS (Sum of Parts I, II & III), measured over 12 weeks.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Full Range |
| Unit | # of points difference |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the change between baseline and Day 84 in the combined score for Parts I, II and III of the International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The registry gives a 12-week timeframe and specifies that the result is a difference in points, summarized by the median and full range.
The measure covers motor and non-motor experiences and complications of Parkinson's disease. Its parts include questions and evaluations with response options ranging from 0, normal, to 4, severe. The registry describes a total possible score of 236. A positive change from baseline to Day 84 indicates worsening in symptoms or disease, while a negative change indicates improvement, according to the registry's outcome description.
General: A combined score can describe overall burden across the included domains, while the direction of change gives a reference for interpreting whether scores rose or fell. A median describes the middle observation in an ordered set of results; the full range describes the lowest and highest observed values. These summaries do not, on their own, show how uncertain the estimated change is or what happened in each component of the scale. The numerical median and range for this endpoint are not reported in the registry record, so the observed change cannot be characterized from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a primary outcome and its interpretation, but it does not report the numerical primary outcome result. There is no posted median change or full range in the registry record. Therefore, the direction, size, and spread of the observed MDS-UPDRS changes cannot be described. The outcome definition states how positive and negative changes should be interpreted, but that definition is not a substitute for the participants' observed results.
The study is single-group, with no listed comparator. Any change from baseline would describe change over time among the participants contributing to the outcome; it would not, by itself, estimate how those changes compare with a separate untreated or alternative-treatment group. A single-group before-and-after result cannot separate the intervention's contribution from other influences on measurements or participants during follow-up. This is a general limitation of interpreting change without a concurrent comparison group, not a finding about what caused any individual participant's change.
The registry gives an enrollment of 9, but the primary outcome population is defined by completion of an end-of-treatment visit or an early termination visit. The number contributing to that outcome, and the amount of missing outcome information, are not reported in the registry record. The enrollment figure should therefore not be treated as confirmation that all enrolled participants contributed to the primary analysis.
The stated summary is a median with the full range. This provides information about the middle observed change and the extremes, if the values are posted, but does not give a confidence interval. General: A confidence interval expresses the uncertainty around an estimate under a statistical model; it is not the same as a range of participant observations. No confidence interval for the primary outcome is reported in the registry record. The statistical test or model used to analyze the primary endpoint is also not reported in the registry record.
The registry status is TERMINATED, and the recorded primary completion date is 2025-02-24. The reason for termination is not reported in the registry record. Without the numerical outcome, the contributing analysis population, and fuller analysis details, the posted record does not support a quantitative assessment of the primary outcome's precision or a between-group treatment comparison. These gaps do not establish that the intervention had either a favorable or unfavorable effect.
9. Statistical Methods Explained
What does the median summarize?
The registry specifies a median for the change in MDS-UPDRS score. General: The median is the central value after observations are ordered. It is often useful when a small set of observations includes values that are far from the center, because the median is less influenced by extreme values than the arithmetic mean. In a small study, however, a median can be sensitive to the particular observations collected, and it does not describe every participant's response.
The median change and the individual changes answer different questions. A median describes the center of the observed distribution; it does not show how many participants improved or worsened, whether changes were similar across participants, or which MDS-UPDRS components contributed to the overall score. The registry record does not report the numerical median or participant-level changes for this outcome.
What does the full range add?
The outcome is also specified as a full range. General: A range records the smallest and largest observed values and can show how widely observations extend. It is not a measure of precision for the median. In a small group, the range can be strongly affected by the two most extreme observations, and it does not show the pattern of values between those extremes. No numerical range for the primary outcome is reported in the registry record.
Neither a median nor a range is a confidence interval. General: A confidence interval is an inferential summary of uncertainty around an estimate, calculated using a statistical method and assumptions. It can help readers assess how much uncertainty remains about an underlying value. The registry record does not report a confidence interval for the primary endpoint or a method for calculating one.
How should change from baseline be understood?
The primary outcome is defined as the change between baseline and Day 84. The registry's interpretation is that a positive change indicates symptom or disease worsening and a negative change indicates improvement. This direction rule explains how to read a reported value; it does not state what the result was.
General: A before-and-after change uses each participant's baseline as a reference. A group summary of those changes can describe how measurements shifted over the follow-up period among the participants analyzed. Without a concurrent comparator group, it cannot show what the same participants' measurements would have been over that period under a different condition. Because this is a single-group study, no randomized between-group effect is defined in the registry record.
Why does the design matter?
Allocation is recorded as NA, masking as NONE, and the model as SINGLE GROUP. The registry also identifies the study as not being a randomized comparison. These design features mean the record does not describe a concealed allocation process or a blinded comparison between treatment groups. The single-group structure is consistent with the stated focus on feasibility and safety, but the registry record does not report a protocol explaining the design choices or a formal statistical analysis plan.
General: In comparative trials, random allocation can help balance known and unknown participant characteristics between groups, while masking can reduce some forms of expectation or measurement influence. Neither feature can create a comparison in a study with one group. The absence of a comparator is therefore central when interpreting any change over time.
What do the planning assumptions mean?
The registry's planning illustration is distinct from the study design. Its stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect expressed as a fraction of the observed effect. It specifies that time-to-event illustrations use a total number of events and other illustrations use participants per arm. These assumptions describe a hypothetical two-arm planning framework; they do not change the fact that the registered study is single-group.
General: A sample-size planning calculation estimates the number of observations needed under chosen assumptions to detect a specified effect with a chosen degree of statistical power. Such a calculation is not the same as an observed result, and it does not establish the probability that a particular study's conclusion is correct. The planning assumptions do not report a justification for the enrollment of 9, and that justification is not reported in the registry record. Numerical planning results are not reported in the registry record.
The planning illustration is described as based on the observed effect, but the numerical primary outcome result is not reported in the registry record. The illustration therefore should not be read as evidence that the study had a particular observed power or that it was designed around a stated target effect. The registry record does not report the statistical test used for the primary outcome, an interim analysis plan, or model details beyond the specified summary as median and full range.
What can be inferred from the posted analysis information?
The registry lists 4 outcome measures and 2 analyses. It names the MDS-UPDRS sum as the primary outcome and lists MoCA among the secondary outcomes. The record does not provide enough detail to determine which analysis corresponds to each outcome, how changes were calculated for every measure, or whether adjustments were made for multiple analyses.
General: Over-dispersion occurs when variation in data is greater than a statistical model assumes. If a model assumes too little variability, standard errors and confidence intervals may be misleading, and tests may be poorly calibrated. Whether over-dispersion is relevant depends on the outcome and analysis model. The registry record does not identify a model for which over-dispersion can be assessed, so no claim about its presence or handling can be made.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies MDS-UPDRS Parts I, II and III summed as the primary outcome and lists Montreal Cognitive Assessment (MoCA) as a secondary outcome. It also records 4 outcome measures and 2 analyses. The other outcome measures and the mapping between outcomes and analyses are not reported in the registry record.
When a study evaluates multiple outcomes or performs multiple statistical tests, the chance of at least one apparently notable result can increase. General: Multiplicity procedures are methods for controlling or describing that issue, for example by adjusting significance thresholds or by defining a hierarchy of outcomes. Whether such procedures were planned or used in this study is not reported in the registry record. No adjustment method or prespecified testing sequence is reported in the registry record, so the role of multiplicity in interpreting any results cannot be evaluated.
The primary outcome population is described as participants who completed an end-of-treatment visit or an early termination visit. The number of participants in this population, the number with baseline and follow-up measurements, and the handling of incomplete measurements are not reported in the registry record. The record also does not report whether any imputation, sensitivity analysis, or other missing-data method was used.
The registry enrollment is 9, but the analysis population should not be assumed to include every enrolled participant. The record does not report an intention-to-treat population, a per-protocol population, or another named analysis population. It also does not explain how early termination visits were incorporated into the primary outcome calculation beyond stating that participants completing such a visit are within the described population.
Without details on missing outcomes, analysis populations, and multiplicity procedures, the statistical robustness of the reported outcome summaries cannot be assessed. The primary outcome's numerical result itself is not reported in the registry 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 |
|---|---|---|---|
| Investigational Treatment | 2 | 9 | 22.2% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Investigational Treatment | 1 of 9 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Investigational Treatment | 4 of 9 |
Most frequent serious adverse event terms
| Event term | Organ system | Investigational Treatment |
|---|---|---|
| COVID-19 | Infections and infestations | 2 of 9 |
| Pneumonitis | Infections and infestations | 1 of 9 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Investigational Treatment |
|---|---|---|
| Device Site Discomfort | Ear and labyrinth disorders | 4 of 9 |
| Fall | Injury, poisoning and procedural complications | 2 of 9 |
| Difficulty with return of objects | Nervous system disorders | 1 of 9 |
Serious events with the highest arm-level rate: covid-19 (22.2%), pneumonitis (11.1%).
The registry records 9 participants at risk in the investigational treatment group. It reports 2 participants affected by serious adverse events and 4 affected by other adverse events. One death is recorded. These are safety counts for the single treatment group; there is no comparator group in the registry record for a between-group safety comparison.
The listed serious adverse event terms are COVID-19 at 22.2% and Pneumonitis at 11.1%. Those percentages describe the reported terms in the registry record; they do not establish that the events were caused by the device or treatment. The relationship of the serious events or the death to treatment is not reported in the registry record. The registry record also does not provide enough detail to determine timing, duration, resolution, or participant-level overlap among event categories.
General: Safety counts describe events observed and recorded in a study, not the probability of harm for every person who might receive an intervention. In a small single-group study, event counts can be especially imprecise and cannot be compared with an unobserved control experience. A reported death should be distinguished from a treatment-related death unless the record explicitly establishes that relationship; the relationship is not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record documents a study of non-invasive brainstem stimulation in adults with mild or moderate Parkinson's disease dementia, with a stated focus on feasibility and safety. It defines a primary clinical outcome: change from baseline to Day 84 in the sum of MDS-UPDRS Parts I, II and III. It also records safety information for the investigational treatment group.
The numerical primary outcome result is not reported in the registry record. As a result, the posted record does not show the median change, the full range, or the distribution of individual changes. It is not possible to characterize from this record whether the measured scores tended to rise or fall, how large changes were, or how variable they were. The outcome's directional interpretation is stated, but the observed value is absent.
The single-group design does not provide a concurrent comparison group. General: Changes observed between baseline and follow-up can be informative descriptively, but without a comparator they do not isolate the effect of an intervention from other influences over time. The design therefore does not yield a randomized treatment-versus-control estimate.
The registry's enrollment of 9 and its safety counts should be read in that context. The number contributing to the primary outcome is not reported in the registry record, and there is no comparative safety estimate. The recorded adverse events and death are observations in the treatment group; the relationship to treatment is not reported in the registry record.
These limits do not demonstrate that treatment was effective or ineffective, nor do they establish that it was safe or unsafe. They define what can be concluded from the posted record: the study design and outcome definitions are described, while the numerical primary outcome result and important analysis details are not reported in the registry record.
13. Why This Trial Matters Statistically
This study is statistically notable because the registry describes a clinical outcome in a single-group study rather than a randomized comparison. The distinction matters: a baseline-to-follow-up change can summarize what happened to participants who were measured, but it cannot by itself estimate how those outcomes would compare with a separate control condition.
The record also specifies a median and full range for the primary outcome. Those summaries emphasize the center and spread of observed changes rather than an average treatment-versus-control difference. General: Different summaries answer different questions, and their usefulness depends on the shape and amount of observed data. For a small enrolled group, participant-level patterns and uncertainty are particularly relevant to interpretation. The numerical outcome summaries and the number of participants contributing to them are not reported in the registry record.
The registered outcome population includes participants completing an end-of-treatment visit or an early termination visit. That definition makes the analysis population an important part of interpreting the result, yet its size and the approach to missing measurements are not reported in the registry record. The registry also lists multiple outcomes and analyses without reporting how multiplicity was handled.
Finally, the planning assumptions describe a hypothetical two-arm calculation, whereas the registered study is single-group. Keeping planning illustrations separate from the design and results prevents a sample-size calculation from being mistaken for evidence about observed treatment effects or statistical power. The registry record does not report numerical planning results or a sample-size justification.
Taken together, these features make clarity about design, outcome summaries, and missing information essential. They also show why statistical interpretation must be bounded by what the record actually reports rather than by assumptions about unreported analyses.
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 registered study has no comparator group and is not described as randomized. This limits interpretation of changes over time because the registry does not provide a concurrent control experience. Masking is recorded as NONE, and the record does not describe a blinded outcome assessment process.
Enrollment is recorded as 9, while the primary outcome population consists of participants who completed an end-of-treatment visit or an early termination visit. The number contributing to the primary outcome is not reported in the registry record. The record also does not report the number of missing measurements, reasons for missingness, or methods used to address missing outcome data.
The numerical primary outcome result is not reported in the registry record. Thus, the median change and full range cannot be evaluated. The record does not report confidence intervals, a primary-outcome statistical test, or a model for inferential analysis. It lists 4 outcome measures and 2 analyses, but the analysis details and any multiplicity strategy are not reported in the registry record.
The registry status is TERMINATED, but the reason for termination is not reported in the registry record. The relationship of reported serious adverse events and the recorded death to the intervention is also not reported. These omissions limit interpretation of both the outcome and the safety information; they do not, on their own, establish the presence or absence of a treatment effect or treatment-related harm.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: SHARPEN - Parkinson's Disease Dementia — NCT05987540.
- Registry record last updated 2025-05-09; status last verified 2025-04.
- Results first posted 2025-05-09.
- 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
NCT05987540, SHARPEN - Parkinson's Disease Dementia, is a terminated, single-group study sponsored by Scion NeuroStim. The registry records enrollment of 9, a start date of 2024-05-08, and a primary completion date of 2025-02-24. Allocation is listed as NA and masking as NONE.
The study evaluates non-invasive brainstem stimulation, described as time-varying caloric vestibular stimulation, in adults with mild or moderate Parkinson's disease dementia. Its primary outcome is change from baseline to Day 84 in the summed MDS-UPDRS Parts I, II and III, summarized by median and full range. MoCA is listed as a secondary outcome.
The numerical primary outcome result, the primary outcome analysis population size, the reason for termination, and further statistical analysis details are not reported in the registry record. Safety information includes 2 participants affected by serious adverse events, 4 affected by other adverse events, and 1 death among 9 at risk; causal relationships are not reported.