Pilot Study for Automated Deep Brain Stimulation Programming: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Pilot Study for Automated Deep Brain Stimulation Programming (NCT02046863), a na na study. The primary outcome is Percent Change From Baseline in Kinesia HomeView Symptom Ratings After Guided DBS Programming.

2. Clinical Question

Statistically, the question is whether symptom ratings measured under the selected stimulation setting differed from ratings at baseline in this group. The endpoint combines ratings across tremor and finger-tapping measures. Because the record does not give an outcome estimate or an analysis, it does not establish how large or consistent any observed change was. Nor does the design, as described, permit a direct comparison of software-guided programming with a concurrent control condition. The stated aim is to evaluate automated programming using functional mapping; the registry record does not report evidence that the approach improves outcomes relative to another programming strategy.

3. Trial Design

This was a completed, single-group pilot study of automated DBS programming, registered as NCT02046863. The intervention was a device called Automated Programming, described as DBS settings changed with guidance from prototype DBS-Expert software. The record lists enrollment as 7. Allocation is listed as NA, masking as none, and the study model as single group. Phase is listed as NA.

The study description says tremor, bradykinesia, and dyskinesia were assessed at each DBS setting. For the primary endpoint, symptoms were first assessed with the implanted pulse generator turned off for at least 30 minutes, to allow stimulation after-effects to wear off. Symptoms were then assessed with the generator on at a setting intended to minimize the average severity of tremor and bradykinesia while also minimizing side effects. The endpoint timeframe is within two days of a standard clinical DBS programming session.

The registry lists a start date of 2013-11, primary completion of 2014-08, and status as completed. Great Lakes NeuroTechnologies Inc. is listed as the sponsor. The record does not report the number of study sites, eligibility criteria, participant demographics, or additional details about the programming procedure.

Because the design has one group and no masking, it is not a randomized comparison. The baseline assessment is a reference measurement, not a parallel control group. A before-and-after measurement can describe change over time in the assessed participants, but without a concurrent comparator it cannot separate an intervention-associated change from other explanations, such as ordinary symptom variability or effects of assessment and clinical care. These are general design considerations, not findings reported by the study. The registry lists one outcome measure and no analysis entries.

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

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 Percent Change From Baseline in Kinesia HomeView Symptom Ratings After Guided DBS Programming, measured over Within two days of standard clinical DBS programming session.

The primary endpoint is percent change from baseline in Kinesia HomeView symptom ratings after guided DBS programming. It is a continuous outcome summarized in the registry as a mean with standard deviation. The underlying symptom score rates severity from 0, normal, to 4, most severe. The score averages four motor-symptom categories: tremor, finger-tapping speed, finger-tapping amplitude, and finger-tapping rhythm.

Baseline ratings were taken with the implanted pulse generator turned off for at least 30 minutes. A later rating was taken with the generator on at a setting chosen to minimize the average severity of tremor and bradykinesia while minimizing side effects. The specified timeframe is within two days of a standard clinical DBS programming session.

A continuous symptom measure can retain information about the degree of change rather than reducing outcomes to categories such as improved or not improved. Averaging the listed symptom categories gives a combined measure, while also meaning that the overall score may not show how each individual symptom changed. The registry record does not report the formula used to convert the averaged scores to percent change, the observed mean, the standard deviation, or a confidence interval. Without those results, neither the magnitude nor the precision of the endpoint can be assessed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is continuous: a percent change in a symptom-rating score. The registry describes its summary as a mean and standard deviation. The mean represents the average outcome across the analyzed observations. The standard deviation describes how spread out individual observations are around that average; it is not the same as uncertainty in the estimated mean. Both are useful for describing a group, but neither is reported as an outcome result in this record.

A confidence interval is a general statistical tool for expressing uncertainty around an estimate. It gives a range of values compatible with the data and the method used, rather than a guarantee that the true value lies in that range. The registry record does not report a confidence interval for the primary endpoint. Without an estimate and its uncertainty, readers cannot assess whether the data are compatible with a small change, a larger change, or substantial variation.

The endpoint compares a baseline symptom assessment with an assessment under stimulation at a selected setting. For paired measurements, the relationship between each participant’s baseline and later measurement matters to the uncertainty of the average change. General statistical methods for paired data use that within-participant relationship. The registry record does not describe a statistical model, test, or calculation for the endpoint, and it does not provide the paired measurements or their summary.

Percent change is a relative scale, whereas an untransformed score difference is an absolute scale. In general, a percentage can be difficult to interpret without knowing the baseline values and the calculation convention. The record says that four motor-symptom ratings were averaged and converted to percent change from baseline, but does not report the conversion formula or the resulting values. The score scale is 0 to 4, with higher scores representing greater symptom severity; the record does not specify how to interpret the sign of the percent-change result.

The design is single group, with no allocation method and no masking. In general, an unmasked, single-group before-and-after assessment can describe change in those measured, but it lacks the concurrent comparator needed to estimate how outcomes would have differed under another programming approach. A baseline assessment can help anchor measurement, but it does not control for changes over time or other influences. These are general principles of study design, not claims about what occurred in this study.

The registry record lists no analysis entries. It does not report a prespecified analysis method, treatment of missing observations, or a definition of the analysis population. No standard errors, confidence intervals, p-values, adjusted estimates, or participant-level results are reported. Thus, there is no posted inferential analysis to interpret, and no basis in the record for judging whether an estimate was adjusted or whether any assumptions were checked.

The record also includes a sample-size planning description: the illustration is based on the observed effect, uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. It specifies total events for time-to-event calculations and participants per arm for other calculations. These are planning assumptions, not evidence about the trial’s actual design: this study is listed as single group. The illustrations are not observed power, and the registry record does not report the numerical observed effect needed to assess such planning values. A planning calculation cannot replace a reported outcome estimate or analysis.

Over-dispersion is a general issue for count outcomes when variability exceeds what a simple count model assumes. It is not the relevant description of this primary endpoint, which is continuous, and the registry record does not report a count-outcome analysis. More generally, statistical methods should match the outcome scale and study design. For this record, the central interpretive limitation is that the continuous outcome is defined but its result and analysis are not reported.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Automated Programming")
n   <- c(7)
m   <- c(-35.7)
sp  <- c(37.8)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Automated Programming  7  -35.700  37.800  -70.659  -0.741

11. Multiplicity, Missing Data and Analysis Populations

The registry lists one outcome measure, identified as the primary endpoint, and no analysis entries. It does not report a multiplicity plan, such as how testing across several outcomes or analyses would be handled. The fact that the intervention description mentions assessments of tremor, bradykinesia, and dyskinesia does not establish which additional outcomes were formally analyzed. Any such outcome definitions or analyses are not reported in the registry record.

Missing-data handling is not reported in the registry record. The record does not state whether all enrolled participants contributed endpoint measurements, how unavailable ratings would be handled, or whether any imputation method was used. Enrollment is listed as 7, but enrollment alone does not establish the number included in an endpoint analysis.

The analysis population is not reported in the registry record. There is no description of inclusion rules for the analysis, exclusions after enrollment, or whether analyses followed any prespecified population definition. Because no analysis entries or primary result are listed, it is also not possible to check whether the analyzed observations correspond to the intended outcome population.

These omissions limit assessment of selective reporting and the sensitivity of results to missing observations. They do not show that data were missing or that analyses were omitted; the registry record simply does not report those details. A complete statistical interpretation would require the analysis methods, the number of observations contributing to the endpoint, and the handling of missing measurements.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The adverse-event record lists the Automated Programming group with 7 at risk for serious adverse events and 0 affected. It also lists 7 at risk for other adverse events and 0 affected. These are the registry’s recorded counts for the group, not estimates of comparative risk: there is no separate control group.

The counts should be read as recorded event information, not as proof that no safety events occurred outside the definitions or reporting period used. The registry record does not describe the observation period, event-collection procedures, or detailed definitions used for these categories. The deaths field is null, so deaths are not reported in the registry record; a null entry should not be read as a reported count of zero.

With enrollment of 7, the listed counts come from a small pilot group. General statistical interpretation is that zero recorded events in a small group does not establish that the underlying risk is zero. The record does not provide event-level descriptions or a comparison that would support a relative safety assessment.

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

This record establishes that a completed pilot study evaluated prototype software-guided changes to DBS settings in a single group. Its primary endpoint was defined as percent change from baseline in a combined Kinesia HomeView symptom rating. It also records the assessment sequence and the selected-setting objective. Those details describe what the study set out to measure; they do not report what the measurements showed.

The primary outcome estimate, standard deviation, confidence interval, and statistical test are not reported in the registry record. Therefore, readers cannot determine the direction or magnitude of the reported endpoint, how variable outcomes were, or how precise an estimate might be. The record does not support a conclusion that programming improved symptoms, worsened symptoms, or produced no change.

The single-group design also limits causal interpretation. A baseline assessment is not equivalent to a concurrent comparison group, and masking was none. In general, changes between assessments can reflect factors other than the intervention. The record does not provide a randomized or otherwise controlled estimate comparing automated programming with another programming strategy.

Enrollment was 7, and the record lists no analysis entries. It does not report participant characteristics, missing-data handling, or the analysis population. The adverse-event entries show 0 affected for serious and other adverse events among 7 at risk in the listed group; deaths are not reported in the registry record. These entries do not provide a comparative safety estimate.

Accordingly, the registry record describes a pilot’s purpose, design, measurement, and recorded safety counts, but not the outcome evidence needed to judge the size, precision, or comparative meaning of a symptom change. The stated aim of developing functional mapping and automated parameter selection should be distinguished from a demonstrated effect: the aim is described, while the primary result is not reported.

14. Why This Trial Matters Statistically

This study is statistically notable as a small, single-group evaluation of a complex programming process rather than a randomized comparison. DBS programming involves choosing settings, and the registry description frames the challenge as selecting among many possible combinations while considering symptom severity, side effects, and battery consumption. The study explores whether functional mapping and software guidance could support that process.

The endpoint illustrates a common measurement challenge: a combined score can summarize several symptoms, but an average may not reveal whether each component moved in the same direction. Here, the score averages tremor and three finger-tapping characteristics. Reporting the component outcomes alongside the combined measure would help readers understand what the summary represents, but such results are not reported in the registry record.

It also illustrates why outcome definitions and outcome results must be distinguished. The record gives a baseline procedure, a stimulation-on assessment, a scale, and a timeframe. These details clarify the planned measurement. They do not supply an estimated change or its uncertainty. Statistical conclusions depend on both a well-described measure and reported data with an analysis appropriate to the design.

Finally, the record’s sample-size planning description uses a two-arm framework even though the study is listed as single group. Such calculations are planning illustrations, not an analysis of this pilot and not observed power. The contrast highlights the importance of separating study design, planning assumptions, and outcome evidence when interpreting registry information.

15. 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.

Enrollment was 7, and the study had a single group. This limits the scope of what can be learned about variation across participants and prevents a direct comparison with an alternative programming approach. The registry does not report participant characteristics, so the applicability of the enrolled group to other people with the named conditions cannot be assessed from this record.

Masking was none. The record does not describe safeguards against knowledge of the selected setting influencing assessment. Because the endpoint is based on symptom ratings, this is a relevant design consideration, although the record does not report whether or how it affected measurements.

The primary endpoint compresses ratings for tremor, finger-tapping speed, amplitude, and rhythm into an average before conversion to percent change. A combined measure can obscure differences among its components. The record does not report component-level outcomes, the percent-change formula, or the primary result.

The endpoint timeframe is within two days of a standard clinical programming session, and baseline was assessed with stimulation off for at least 30 minutes. The registry does not report longer-term follow-up, so persistence of any change cannot be assessed. It also does not report the analysis population, missing-data methods, inferential methods, or a multiplicity plan. Together with the absence of a reported outcome analysis, these gaps constrain statistical interpretation.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Pilot Study for Automated Deep Brain Stimulation Programming — NCT02046863.
• Registry record last updated 2016-09-22; status last verified 2016-08.
• Results first posted 2016-08-09.
• 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.

19. Record Summary

NCT02046863 is a completed, single-group pilot study of prototype DBS-Expert software-guided programming. Enrollment was 7; allocation is listed as NA and masking as none. Great Lakes NeuroTechnologies Inc. is the listed sponsor. The record lists a start date of 2013-11 and primary completion of 2014-08.

The primary endpoint is percent change from baseline in Kinesia HomeView symptom ratings, measured within two days of a standard clinical DBS programming session. The rating averages tremor and finger-tapping speed, amplitude, and rhythm. The registry describes a mean and standard deviation as the outcome summary but does not report the endpoint result or an analysis. It lists 0 affected for serious and other adverse events in the group; deaths are not reported in the registry record.