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 Retrospective, Non-significant Risk, Deep Brain Stimulation (DBS) Care Management Software Feasibility Study (NCT01750242), a registered phase not stated study. The primary outcome is To Characterize the Percentage of Leads in Which the Target Map and the Clinically-derived Activation Map Overlap.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01750242 |
| Phase | Phase not stated |
| Condition | Parkinson's Disease |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 20 |
| Arms in the primary outcome | n/a |
| Lead sponsor | MedtronicNeuro |
| Results posted | Yes |
2. Clinical Question
Population
People with advanced Parkinson’s disease who had a Medtronic DBS system implanted in the subthalamic nucleus. The registry lists enrollment of 20 and describes the primary analysis population as per protocol; the number with readable images is not reported in the registry record.
Intervention
The registered intervention is the Medtronic DBS system. The study purpose was to evaluate DBS device settings and how they matched features of DBS care management software. This is a feasibility and map-concordance question, not a treatment comparison.
Comparator
A randomized comparator is not stated, and the registry notes that the arms are not a like-for-like control comparison. A separate comparator group is not reported in the registry record.
Primary question
For leads included in the analysis, what percentage had overlap between the target map and the clinically derived activation map? The endpoint timeframe is 18 months. The numerical percentage and its confidence bound are not reported in the registry record.
In plain terms, the study asks whether a map generated from a target and a map derived from clinical activation correspond for implanted DBS leads. The stated purpose is to characterize that correspondence, rather than to estimate a difference in clinical outcomes between randomized treatment groups.
General: a concordance measure describes agreement between two representations or classifications. It does not by itself establish that either representation is clinically superior, that a software feature changes care, or that patients experience a benefit. Those questions require outcomes and comparisons designed to address them. The registry lists an additional study measure involving UPDRS III scores, but does not report its numerical result in the registry record.
3. Trial Design
The registry describes a retrospective, non-significant risk feasibility study, titled the OPTIVISE Map Concordance Study in DBS for Parkinson’s Disease. Its status is completed. Enrollment is listed as 20, and the population is described as subjects with advanced Parkinson’s disease implanted with a Medtronic DBS system in the subthalamic nucleus. MedtronicNeuro is listed as the sponsor. The recorded study start is 2012-11 and primary completion is 2013-05.
The registered intervention is a device, the Medtronic DBS system. The brief summary describes evaluating DBS device settings and matching them with features of DBS care management software. The primary objective is to characterize the percentage of leads with overlap between a target map and a clinically derived activation map. The primary outcome timeframe is 18 months.
The primary analysis is labeled per protocol. Its description specifies that the one-sided 95% exact binomial lower confidence bound was calculated from subjects with readable images enrolled in the study. The number of subjects with readable images, the observed overlap percentage, and the confidence bound itself are not reported in the registry record.
This is not described as a randomized comparison. The registry states that allocation is not stated and that the arms are not a like-for-like control comparison. Accordingly, the design does not support interpreting the primary endpoint as a randomized contrast between treatment groups. Additional details about recruitment, eligibility criteria, image acquisition, software procedures, protocol deviations, or the handling of multiple assessments are not reported in the registry record.
The registry lists two outcome measures and two analyses, including an additional study measure on UPDRS III scores. It does not report the numerical result for that measure. These design details frame what can be interpreted: the record identifies a feasibility and map-concordance objective, but does not provide enough outcome detail to quantify concordance or evaluate a clinical effect.
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: Following enrollment but prior to analysis, MRIs were evaluated for readability. Those unreadable were excluded from analysis (N=3).
Overall Study
| Stage | PD Patients Implanted With DBS System |
|---|---|
| STARTED | 23 |
| Readable Images | 20 |
| COMPLETED | 20 |
| NOT COMPLETED | 3 |
Reasons for not completing this period:
| Reason | PD Patients Implanted With DBS System |
|---|---|
| Unreadable Images | 3 |
Analysis population for the primary outcome, as defined in the registry: Per Protocol
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: Per protocol
| Characteristic | Unit | Subjects With Advanced Parkinson's Disease |
|---|---|---|
| Participants analysed | 20 | |
| Age, Continuous | years | 68 (SD 7.8) |
| Sex: Female, Male: Female | Participants | 4 |
| Sex: Female, Male: Male | Participants | 16 |
| UPDRS III scores at baseline | units on a scale | 39.4 (SD 12.2) |
6. Primary Endpoint
The registry lists the primary outcome as To Characterize the Percentage of Leads in Which the Target Map and the Clinically-derived Activation Map Overlap, measured over 18 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of leads |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the percentage of leads in which the target map and the clinically derived activation map overlap. It is intended to summarize map concordance: whether the target representation corresponds with the activation map derived from clinical information. The registry gives the unit as percentage of leads and specifies a timeframe of 18 months.
The endpoint is relevant to the stated feasibility purpose because the study evaluates device settings in relation to features of DBS care management software. A lead-level overlap measure can describe how often the maps correspond within the analysis population. It does not, on its own, measure symptom change, quality of life, safety, or the effect of using the software. The registry’s separate listing of UPDRS III as an additional study measure does not make it part of the stated primary endpoint.
The endpoint description says that a one-sided 95% exact binomial lower confidence bound was calculated using subjects with readable images enrolled in the study. This identifies the stated method and the population basis, but does not provide the observed percentage, the number of readable images, or the numerical confidence bound. Those results are not reported in the registry record. Without those values, the magnitude and precision of the observed map overlap cannot be assessed from the registry record.
General: a percentage expresses the frequency of a defined event within a defined denominator. Its interpretation depends on how the event and denominator are specified. Here, the event is map overlap for a lead, while the description identifies subjects with readable images as the analysis basis. Details linking included subjects to evaluated leads are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry defines a primary question and an analysis method, but the numerical primary result is not reported in the registry record. In particular, the observed percentage of leads with map overlap, the number of subjects with readable images, and the one-sided 95% exact binomial lower confidence bound are not reported. The direction or magnitude of concordance therefore cannot be characterized from the registry record.
The confidence-bound description indicates an effort to quantify uncertainty around the proportion. A lower confidence bound is not the observed proportion itself; it is a lower endpoint from an interval procedure. Because neither the estimate nor the bound is stated, no conclusion about the precision of the result can be drawn. The stated confidence level describes the method, not the certainty that any individual lead’s maps agree.
The analysis population is labeled per protocol and is described as subjects with readable images enrolled in the study. The record does not state how many enrolled subjects had readable images or whether any enrolled subjects were excluded for other reasons. The effect of image readability or protocol adherence on the endpoint cannot be assessed. The record also does not report whether the people whose images were readable differed from those whose images were not readable.
The study is retrospective and does not state a randomized allocation. Its arms are explicitly described as not being a like-for-like control comparison. Therefore, the record does not establish a randomized treatment contrast, and the primary endpoint should be understood as a descriptive concordance objective rather than evidence of a causal effect. The registry’s additional UPDRS III measure is listed, but its result is not reported in the registry record.
Safety entries require similar restraint. For the listed group, the registry records zero for the serious and other adverse-event at-risk and affected counts. The death count is not reported in the registry record. Because the at-risk counts are recorded as zero, the adverse-event entries do not establish that no events occurred among a defined exposed population. The record does not supply further context to interpret those entries.
The registry describes planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. These are planning assumptions, not evidence of observed power or a description of the original study’s design rationale. The registry does not report the original sample-size justification, and the numerical planning outputs are not reported in the registry record.
Overall, the registry supports describing the study question, population, and stated interval method. It does not support a numerical statement about map concordance, the precision of that estimate, UPDRS III results, or a treatment effect.
9. Statistical Methods Explained
The primary outcome is a proportion: the percentage of leads in which the target map and clinically derived activation map overlap. The registry describes calculating a one-sided 95% exact binomial lower confidence bound. This is an interval-based approach to uncertainty for a proportion, rather than a statement of the observed proportion alone. The numerical estimate and bound are not reported in the registry record.
What does an exact binomial bound describe?
General: a binomial model represents repeated observations classified into one of two categories, such as overlap or no overlap, under assumptions about how observations are generated. An exact interval procedure derives a confidence bound from the binomial distribution rather than relying on a large-sample approximation to that distribution. The lower bound marks a value below which the data would be relatively inconsistent under the procedure’s stated confidence level and assumptions. It does not mean that the true proportion is guaranteed to exceed that bound.
The registry specifies a one-sided bound. A one-sided interval addresses uncertainty in one direction, unlike a two-sided interval, which places bounds on both sides of an estimate. The choice of one-sided versus two-sided inference should be considered in light of the prespecified question and analysis plan. That rationale and any prespecified statistical analysis plan are not reported in the registry record. The description alone does not establish when the method was chosen or whether other analyses were conducted.
Why does the analysis population matter?
The registry labels the primary analysis population per protocol and says the confidence bound was calculated from subjects with readable images enrolled in the study. This means the stated analysis is not simply described as using everyone enrolled; image readability forms part of the analysis basis. The number of subjects with readable images and the criteria for readability are not reported in the registry record. Details about how subjects, leads, and images were linked in the calculation are also not reported.
General: restricting analysis to observations with usable measurements can make an analysis feasible, but it can affect interpretation if the observations available for analysis differ systematically from those not available. The registry does not report the extent of unreadable or missing images or compare included and excluded observations. Consequently, the direction or size of any selection effect cannot be assessed from the record.
What does a confidence interval add?
General: an estimate describes the observed data, while a confidence interval communicates sampling uncertainty under a statistical model and procedure. A narrow interval generally indicates greater precision than a wide interval, conditional on the method’s assumptions. Precision is not the same as clinical importance, freedom from bias, or proof of a causal relationship. In this study, the estimate and interval values are not reported, so their width and practical implications cannot be evaluated.
For a lead-level proportion, interpretation also depends on the observational structure. If multiple leads are associated with a subject, those observations may not be statistically independent. The registry’s brief endpoint description does not state whether dependence among leads was assessed or how the analysis handled it. No claim about independence or adjustment for clustering can therefore be made.
How should planning assumptions be read?
The registry describes sample-size planning illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also describes effects as stated fractions of the observed effect. These are planning assumptions for illustrations, not the study’s reported original design rationale. The registry does not report the original sample-size justification, and the numerical planning outputs are not reported in the registry record.
General: planning calculations estimate the number of participants per arm needed to detect a specified effect under chosen assumptions. Their values depend on the assumed effect, variability, allocation, significance level, and target power. When assumptions are based on an observed effect, the planning exercise should not be confused with observed power. It also cannot replace a clear account of the study’s actual design and analysis plan. No values for planning scenarios or target power are reported in the registry record.
The registry does not report a p-value for the primary endpoint, a two-sided interval for it, or a detailed model specification. Any multiplicity adjustment, interim analysis, prespecified handling of repeated measurements, and sensitivity analysis are not reported in the registry record. These omissions limit independent evaluation of the inferential framework.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures and two analyses. It identifies the primary endpoint as map overlap and lists an additional study measure on UPDRS III scores. The numerical result for the additional measure is not reported in the registry record. The record does not describe a hierarchy of hypotheses, a multiplicity adjustment, or how findings across outcomes were intended to be interpreted. Those procedures are not reported in the registry record.
The primary outcome description specifies a per-protocol analysis using subjects with readable images. It does not state the number of subjects with readable images, the number of leads evaluated, or how unreadable images were handled beyond their exclusion from the described readable-image basis. The extent and reasons for missing or unreadable data are not reported in the registry record. No imputation method or sensitivity analysis for missing data is reported.
The record does not explain the per-protocol criteria, report deviations, or describe how subjects were classified in relation to those criteria. Other analysis populations, such as an intention-to-treat population, are not reported in the registry record. The outcome description also does not clarify whether the statistical unit was each lead, each subject, or a subject-level summary of leads, beyond naming the endpoint unit as percentage of leads.
General: multiplicity arises when several outcomes or analyses are considered, because examining more results can increase the chance of at least one apparently noteworthy finding. Missing-data handling matters because results based only on available measurements can be sensitive to why measurements are unavailable. These general considerations cannot establish that bias or inflated error occurred in this study. They identify questions that require details not reported in the registry record.
11. What the Result Does, and Does Not, Mean
The primary endpoint is designed to describe map concordance: the percentage of leads for which the target map and clinically derived activation map overlap. The registry states that a one-sided 95% exact binomial lower confidence bound was calculated in a per-protocol population of subjects with readable images. However, the numerical overlap percentage, denominator, and confidence bound are not reported in the registry record. The result’s size and precision therefore cannot be judged from the recorded information.
Even if a concordance estimate is available elsewhere, that measure would address agreement between maps, not by itself whether the software improves DBS care or changes clinical outcomes. The registry lists UPDRS III as an additional study measure, but does not report its numerical result. A causal conclusion would also require an appropriate comparison and analysis; the registry states that this was not a randomized comparison and that the arms are not a like-for-like control comparison.
The record identifies the study as retrospective and completed, with enrollment of 20. These details describe the study, but do not establish that the analysis was sufficiently precise or that results generalize beyond the population and image data included. The number of readable images is not reported in the registry record, and missing-image handling beyond the stated readable-image basis is not described.
The adverse-event entries should not be interpreted as evidence that no adverse events occurred. The listed group has zero recorded at-risk and affected counts for serious and other events, while the death count is not reported in the registry record. With zero at-risk counts and no further detail, the entries do not define an exposed denominator for assessing event frequency.
In short, the registry record specifies what the primary measure was intended to characterize and the interval method used. It does not report the numerical primary result or the additional UPDRS III result. It cannot establish a clinical benefit, absence of harm, or comparative treatment effect.
12. Why This Trial Matters Statistically
This study illustrates a statistical distinction between a feasibility question and a comparative-effectiveness question. Its stated purpose is to evaluate DBS settings and their match with features of DBS care management software. Its primary endpoint concerns overlap between two maps, rather than a randomized contrast in patient outcomes. Keeping those questions separate prevents a concordance measure from being interpreted as evidence of clinical benefit.
The record also highlights the role of the analysis population. The primary description refers to subjects with readable images and labels the analysis per protocol. Image availability and protocol adherence determine which observations contribute to the stated endpoint, yet the number with readable images and the details of exclusions are not reported in the registry record. Without those details, readers cannot assess how the analysis population relates to enrollment.
The choice of a one-sided exact binomial lower confidence bound is another useful statistical feature to recognize. It indicates an approach to uncertainty for a proportion and specifies the direction and confidence level of the bound. But a method description does not substitute for the estimate and bound. Since those numerical results are not reported in the registry record, the precision of the concordance finding cannot be evaluated.
Finally, the record lists an additional UPDRS III measure and adverse-event entries, but does not provide the numerical clinical measure result or enough adverse-event context to interpret event frequency. This makes clear why outcome definitions, analysis populations, denominators, and numerical results need to be read together. The study record identifies a focused technical question; its available information does not establish broader clinical conclusions.
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 registry record does not report the observed primary endpoint percentage, the number of subjects with readable images, or the one-sided 95% exact binomial lower confidence bound. As a result, the magnitude and precision of map concordance cannot be assessed. The primary endpoint description also does not report the number of leads evaluated or clarify how multiple leads within a subject were handled statistically.
The analysis is labeled per protocol, but the criteria for that population, protocol deviations, and exclusions are not reported in the registry record. The endpoint uses subjects with readable images, yet the number and characteristics of subjects without readable images and the reasons images were unreadable are not reported. This limits assessment of selection and missing-data concerns.
The study is retrospective, and a randomized allocation is not stated. The registry says the arms are not a like-for-like control comparison. Therefore, the record does not support interpreting the endpoint as a randomized contrast or attributing any change to an intervention. Further details about image assessment, map generation, assessor blinding, software use, and timing are not reported in the registry record.
The additional UPDRS III measure is listed without a numerical result. The record does not report a multiplicity strategy, detailed analysis plan, interim analyses, or sensitivity analyses. It also does not report the original sample-size justification. The sample-size assumptions described are planning illustrations, not documentation of the original study design.
Adverse-event entries record zero at-risk and affected counts for the listed categories, but the at-risk counts are also zero; the death count is not reported in the registry record. The record does not provide enough detail to interpret these entries as evidence about event risk.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Retrospective, Non-significant Risk, Deep Brain Stimulation (DBS) Care Management Software Feasibility Study — NCT01750242.
- Registry record last updated 2024-06-03; status last verified 2024-05.
- Results first posted 2014-09-17.
- 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
NCT01750242 is a completed retrospective, non-significant risk feasibility study titled the OPTIVISE Map Concordance Study in DBS for Parkinson’s Disease. The registry lists enrollment of 20, sponsor MedtronicNeuro, a study start of 2012-11, and primary completion in 2013-05. Participants are described as having advanced Parkinson’s disease and a Medtronic DBS system implanted in the subthalamic nucleus.
The primary outcome is the percentage of leads with overlap between the target map and clinically derived activation map, with a stated timeframe of 18 months. The registry describes a one-sided 95% exact binomial lower confidence bound for a per-protocol population with readable images. The percentage, analysis denominator, and confidence bound are not reported in the registry record.
UPDRS III is listed as an additional study measure, but its numerical result is not reported. Randomization is not stated, and the registry notes that the arms are not a like-for-like control comparison. The record therefore defines a map-concordance objective but does not provide the numerical results needed to evaluate its magnitude or precision.