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 Tourette Deep Brain Stimulation (DBS) Target Detection & Suppression (NCT05371041), a na na study. The primary outcome is Yale Global Tic Severity Scale_(YGTSS) - Total Tic Score.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05371041 |
| Phase | NA |
| Condition | Tourette Syndrome |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 8 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Florida |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled and analyzed 8 subjects with Tourette syndrome. The registry summary describes them as having medically refractory, debilitating symptoms. The record does not report further eligibility details or participant characteristics.
Intervention
The intervention is the Medtronic Percept Neurostimulator, an implantable deep brain stimulation device that can record brain signals and deliver stimulation through a control algorithm based on brain activity. The project targets the CM nucleus of the thalamus and the aGPi in each hemisphere.
Comparator
There is no separate comparator group. The study is registered as a single-group project, and the allocation field is listed as NA. It therefore does not provide a randomized, like-for-like control comparison.
Primary question
The registered primary outcome is the Yale Global Tic Severity Scale Total Tic Score at 9 months. The study asks whether this clinician-rated measure can characterize tic severity during a project using a system intended to detect and suppress tics. The posted record does not report the observed score or a statistical estimate of change.
This is a study of a closed-loop system, which combines signal recording with stimulation delivered according to a control algorithm. The study summary describes implantation and monitoring of the system in research subjects. The clinical question is therefore broader than whether a device can deliver stimulation: the project also concerns recording neural signals and using brain activity in a control process. However, the posted primary endpoint is a clinical severity score, not a direct measure of signal detection, algorithm performance, or stimulation delivery. Those distinctions matter when interpreting what the registered outcome can establish.
3. Trial Design
The registry describes a single-group, device study sponsored by the University of Florida. It lists the phase as NA, allocation as NA, and masking as NONE. Enrollment was 8, and the primary outcome population is also described as 8 subjects analyzed. With no separate comparison arm, the design does not support a randomized contrast between the device and a control intervention.
The project plans implantation and monitoring using the Medtronic Percept PC, which the summary describes as an implantable neurostimulator capable of recording neural signals. The targets are the CM nucleus of the thalamus and the aGPi in each brain hemisphere. The record says that the two leads placed in each hemisphere are connected to two Percept devices. These details describe the planned system configuration; they do not constitute a report of clinical outcome.
The registered study start date is 2022-06-20, and the primary completion date is 2026-05-01. The status is active, not recruiting. Those registry fields describe the record's timing and status; they do not establish that the project is complete or that its primary endpoint has been analyzed. The record lists one outcome measure and zero analyses. It does not report further detail about the analysis plan, follow-up procedures, or how outcome observations were summarized.
A single-group design can describe outcomes observed among enrolled participants, but without a concurrent comparator it cannot separate changes associated with the study intervention from other explanations. The registry record does not report a comparison with usual care, sham stimulation, or another device setting. Accordingly, the posted information is best read as a study description and an outcome-measure listing, rather than as a controlled estimate of an intervention 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: There were no pre-assignment details. All subjects were assigned to the same arm.
Overall Study
| Stage | 9 Month Primary Outcome |
|---|---|
| STARTED | 8 |
| COMPLETED | 8 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: 8 Subjects were analyzed, 8 subjects were enrolled.
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 | Medtronic Percept Neurostimulator |
|---|---|---|
| Participants analysed | 8 | |
| Age, Categorical: <=18 years | Participants | 2 |
| Age, Categorical: Between 18 and 65 years | Participants | 6 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 7 |
| Sex: Female, Male: Male | Participants | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 1 |
| 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 | 7 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 8 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| YGTSS Score: S1 | Scores on a scale | 94 |
| YGTSS Score: S2 | Scores on a scale | 96 |
| YGTSS Score: S3 | Scores on a scale | 94 |
| YGTSS Score: S4 | Scores on a scale | 91 |
| YGTSS Score: S5 | Scores on a scale | 87 |
| YGTSS Score: S6 | Scores on a scale | 87 |
| YGTSS Score: S7 | Scores on a scale | 78 |
| YGTSS Score: S8 | Scores on a scale | 84 |
6. Primary Endpoint
The registry lists the primary outcome as Yale Global Tic Severity Scale_(YGTSS) - Total Tic Score, measured over 9 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Scores on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the Yale Global Tic Severity Scale Total Tic Score, measured at 9 months. The YGTSS is described as a clinician-rated assessment of tic severity over the prior week. It begins with a checklist of motor and vocal tics, followed by ratings of number, frequency, intensity, complexity, and interference for motor and phonic tics, scored separately.
The scale description gives separate Total Motor and Total Phonic scores, each ranging from 0 to 25, and a combined Total Tic Severity Score ranging from 0 to 50. It also describes a separate Impairment dimension scored from 0 to 50. The posted primary outcome specifies the Total Tic Score, rather than the separate impairment score, as the measure used in these analyses. The record does not provide an observed Total Tic Score, its variability, or a comparison across time.
A clinician-rated severity scale is useful for representing symptoms in a structured way, rather than relying only on a device signal or an algorithm output. In general, a prespecified clinical scale can give a common framework for assessing symptoms across participants. It does not, by itself, show how accurately a system detects tics or whether a particular signal feature drives stimulation. Those are distinct questions and require corresponding measures and reported analyses. Here, the registry lists the clinical scale and time point, but the endpoint result is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted record establishes that 8 subjects were enrolled and that 8 subjects were analyzed for the primary outcome. It identifies the YGTSS Total Tic Score at 9 months as the primary measure. It does not report the score itself, a change from an earlier assessment, a measure of variability, a confidence interval, or a statistical test. Thus, there is no posted numerical estimate of tic severity at the endpoint to interpret, and no basis in this record for describing the magnitude or precision of an outcome change.
The study is single-group, with no randomized comparator. Even if a within-participant outcome were reported, such a result would describe observations in the enrolled group. Without a control group, it would not provide a direct estimate of how those observations compare with an alternative intervention or with outcomes in a concurrent group not receiving the study system. Other explanations for changes over time cannot be evaluated through a randomized between-group contrast in this design.
The outcome is a clinician-rated score reflecting the prior week, while the intervention summary describes an implanted system that records signals and delivers stimulation through a control algorithm. These represent different levels of measurement: one concerns clinical tic severity, and the other concerns neural signals and device operation. The registry's primary outcome alone cannot show detection accuracy, the timing of stimulation, or the performance of the control algorithm. The record does not report analyses of those measures.
The adverse-event fields should also be read separately from the primary endpoint. The record lists serious adverse events affecting 3 of 8 at risk and other adverse events affecting 8 of 8 at risk. It also lists three serious-event terms, each with a posted percentage of 12.5%. These safety entries do not supply a comparative risk estimate, and they should not be treated as evidence about the primary tic-severity outcome.
Any sample-size illustrations shown alongside the posted results are planning illustrations based on an observed effect, not observed power. In this case, the record does not report a primary outcome effect from which to assess the clinical result. The planning assumptions describe a hypothetical two-arm calculation, whereas the registered study is single-group. Such illustrations cannot fill the missing endpoint result or create a control comparison. The sponsor's own analysis takes precedence if a discrepancy is flagged; no sponsor outcome analysis is listed in this record.
9. Statistical Methods Explained
The main statistical issue in reading this record is the difference between a registered endpoint and a reported result. The registry identifies the YGTSS Total Tic Score at 9 months and reports the analysis population as 8 subjects. It lists zero analyses. The endpoint score and its statistical summary are not reported in the registry record. Without those results, there is no numerical estimate to interpret, regardless of how familiar the scale or study design may be.
What an endpoint estimate would represent
In general, an endpoint estimate summarizes the outcome as measured in the study population. A score summary might describe the observed level of tic severity at the specified assessment, while a change estimate would require a defined earlier measurement and a reported method for comparing assessments. The registry record identifies the endpoint and its timeframe, but it does not report a score summary, a change estimate, or enough information to determine which summary was used. It would therefore be inappropriate to infer an endpoint value or a direction of change.
In general, a confidence interval describes the statistical uncertainty around an estimate under the assumptions of the analysis. It is not a guarantee about an individual participant's outcome. No confidence interval is reported for this primary outcome. A p-value, if available, would address compatibility between data and a statistical null hypothesis under a specified model; it would not by itself establish the size or practical importance of an effect. No primary outcome p-value or model is reported.
What the single-group structure allows
The study is registered as a single-group project, with allocation listed as NA and masking as NONE. In general, a single-group study can describe the experience and observed outcomes of the participants enrolled. A randomized comparison has a different purpose: it estimates a contrast between groups assigned to different study conditions. Because there is no separate comparator in this record, no between-group treatment estimate can be drawn from it. A within-group change, if reported, would also need cautious interpretation because changes may have explanations other than the intervention.
The design information does not state whether repeated assessments were planned or how measurements over time would be handled. Such details are not reported in the registry record. It is therefore not possible to identify a repeated-measures model, a baseline adjustment, or another specific approach from the information posted. General statistical methods should not be mistaken for methods actually used in this study.
How to read planning illustrations
In general, sample-size calculations use assumptions about an effect to plan how much information a future study may need. They are not a summary of what happened in the enrolled participants. The planning description associated with this record says its illustration uses a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. It also distinguishes calculations expressed as participants per arm from time-to-event calculations expressed as a total number of events. These are planning assumptions, not the registered design: this study is single-group, and the record does not report the observed primary outcome effect used for a clinical interpretation.
In general, observed power is not a substitute for a confidence interval or a direct estimate of uncertainty. A planning illustration based on an observed effect does not show the probability that the study found a true effect, and its participant counts should never be described as the number actually analyzed. The actual primary-outcome population is reported as 8 subjects. Any planning values in the tables or plots should be understood as hypothetical illustrations, not observations or evidence that the study had a particular level of power.
Why the outcome scale matters
The YGTSS Total Tic Score combines clinician-rated dimensions of motor and phonic tic severity. The scale description also identifies an Impairment dimension, but the registered primary endpoint is the Total Tic Score. In general, using the specified endpoint helps distinguish the outcome selected for primary reporting from other measures that a scale may contain. The score's range describes the scale's possible values; it does not tell us where these participants scored. Interpretation would require the actual observed values and an appropriate account of their uncertainty, neither of which is posted for the primary endpoint.
Because the number of participants is limited, any estimate, if later reported, would need to be considered alongside its precision and the study's design. This is a general statistical caution, not a claim about a result in this record. The registry does not report a sample-size justification or analysis details sufficient to assess model assumptions, handling of repeated observations, or the treatment of missing endpoint data. Consequently, the statistical interpretation must remain bounded by what is actually posted: a defined clinical measure, a time point, and an analysis population, without an endpoint result.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure and identifies the YGTSS Total Tic Score at 9 months as the primary outcome. It lists zero analyses. The record does not describe a multiplicity adjustment, a hierarchy of hypotheses, or how multiple outcomes or analyses would be handled. A single listed primary measure does not establish that no other exploratory analyses were conducted; those details are not reported in the registry record.
Missing-data handling is also not described. The record states that 8 subjects were analyzed and 8 were enrolled for the primary outcome, but it does not report whether all had an observed score at the endpoint, how incomplete assessments were handled, or whether any imputation or sensitivity analysis was used. Equal counts of enrolled and analyzed participants do not, on their own, identify the method used to handle missing observations or establish that every planned assessment was available.
The analysis population is described as 8 subjects analyzed. The registry does not provide further definitions, such as an intention-to-treat population or a per-protocol population. It also does not report exclusions or the reasons for any analytic decisions. Accordingly, readers can describe the posted population count, but should not assign a more specific population definition than the record supports.
These omissions limit assessment of the analysis process, not just the precision of a result. Without the analysis plan and endpoint data, it is not possible to evaluate multiplicity control, missing-data assumptions, or robustness to alternative analysis choices. These details are 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 |
|---|---|---|---|
| 9 Month Primary Outcome | 3 | 8 | 37.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| 9 Month Primary Outcome | 0 of 8 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| 9 Month Primary Outcome | 8 of 8 |
Most frequent serious adverse event terms
| Event term | Organ system | 9 Month Primary Outcome |
|---|---|---|
| Inpatient hospitalization required for functional (psychogenic) episodes following lead implantation | Psychiatric disorders | 1 of 8 |
| Superficial microabsess in the area of left scalp incision (post DBS surgery) | Skin and subcutaneous tissue disorders | 1 of 8 |
| Post-operative hospital stay extended due to hemorrhage | Nervous system disorders | 1 of 8 |
Most frequent non-serious adverse event terms
| Event term | Organ system | 9 Month Primary Outcome |
|---|---|---|
| Anxiety | Psychiatric disorders | 3 of 8 |
| Nausea and Vomiting | Gastrointestinal disorders | 2 of 8 |
| Device tethering / neurostimulator connection error | Skin and subcutaneous tissue disorders | 1 of 8 |
| Depression | Psychiatric disorders | 1 of 8 |
| Skin Irritation | Skin and subcutaneous tissue disorders | 1 of 8 |
| General Malaise | General disorders | 1 of 8 |
| Influenza | Respiratory, thoracic and mediastinal disorders | 1 of 8 |
| Transient Chest Pain | Cardiac disorders | 1 of 8 |
| Facial swelling post surgery | General disorders | 1 of 8 |
| Transient Panic attack | Psychiatric disorders | 1 of 8 |
Serious events with the highest arm-level rate: inpatient hospitalization required for functional (psychogenic) episodes following lead implantation (12.5%), superficial microabsess in the area of left scalp incision (post dbs surgery) (12.5%), post-operative hospital stay extended due to hemorrhage (12.5%).
The registry safety fields list 8 at risk for serious adverse events and 3 affected. They list 8 at risk for other adverse events and 8 affected. These are the posted counts for the 9 Month Primary Outcome group. The record separately lists deaths as 0. The categories should be kept distinct: the serious-event count is not the same field as the count for other adverse events.
The serious-event terms listed are inpatient hospitalization required for functional (psychogenic) episodes following lead implantation, superficial microabsess in the area of left scalp incision (post DBS surgery), and post-operative hospital stay extended due to hemorrhage. Each term is accompanied by 12.5% in the registry. The record does not report further information about timing, duration, severity grading, relatedness assessment, or whether the terms refer to distinct individuals. The percentages should therefore be read as they are posted, not used to infer additional event counts or participant overlap.
These safety figures are descriptive entries for a small single-group study, not a comparison of risks between randomized groups. The record does not provide a control group or a comparative safety analysis. They should be considered independently from the unreported primary tic-severity result and not treated as evidence of an intervention effect.
12. What the Result Does, and Does Not, Mean
This record describes a research project using a deep brain stimulation system that can record neural signals and deliver stimulation through a control algorithm. It identifies the clinical population, device, brain targets, and a primary clinician-rated tic-severity measure at 9 months. It also reports the number enrolled and analyzed and provides safety-event fields. These are useful details about the study's scope and registered outcome.
The posted information does not include the primary outcome score, a change estimate, a confidence interval, or a statistical test. It therefore does not show the magnitude or precision of tic severity at the endpoint. It also does not report analyses of signal detection, algorithm performance, or stimulation delivery. The presence of a device description and a clinical endpoint is not a substitute for those results.
The single-group design has no randomized comparator. In general, that means a reported outcome could describe what happened among the participants, but would not provide a randomized estimate of how outcomes differed from an alternative group. The record also does not report an analysis plan, missing-data methods, or sample-size justification. These gaps constrain interpretation and make it impossible to assess several aspects of the statistical analysis.
The result does not establish whether the intervention changed tic severity, nor does it establish that it did not. No such conclusion follows from an absent endpoint estimate. The appropriate conclusion is narrower: the registry record specifies a study and outcome but does not report the primary endpoint result. Safety entries are separately posted and likewise do not provide a comparative risk estimate. The tables, plots, and planning illustrations should be read in that context: illustrations can explain assumptions, but they cannot replace an observed clinical result.
13. Why This Trial Matters Statistically
This study raises a statistical question that is central to device research: how to connect a complex technical intervention with a clearly defined clinical outcome. The registered system is intended to record brain signals and deliver stimulation through a control algorithm, while the primary endpoint is a clinician-rated measure of tic severity. Keeping those measurement layers distinct helps prevent an outcome score from being mistaken for evidence about signal detection or algorithm function.
The single-group design also makes the scope of inference especially important. Descriptive results can document outcomes in the enrolled group, but a randomized comparator is not present in this record. In general, the distinction between describing a group's experience and estimating a controlled contrast is fundamental to clinical statistics. The study's design does not support the latter kind of comparison.
Transparency about what is and is not reported matters as much as the device description. The registry identifies the outcome and analysis population, but does not post the primary score or a statistical analysis. That leaves readers unable to assess the endpoint estimate, its precision, or the analysis decisions behind it. Clearly separating the registered question from an unreported result avoids overstating what the record can show.
The statistical tables and plots can help readers understand design assumptions and planning illustrations, but those displays should not be confused with outcome evidence. In particular, hypothetical sample-size planning does not describe the enrolled participants' observed outcomes or provide observed power. This distinction is important when a study is small and the posted results are incomplete: interpretation should remain tied to the actual estimates and methods available, rather than to calculations that answer a different, planning-focused question.
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 most important limitation of the posted record for statistical interpretation is that it does not report the primary endpoint value or an analysis result. Although the YGTSS Total Tic Score and its 9-month timeframe are identified, there is no estimate, uncertainty interval, or test to assess. The listing of 8 subjects analyzed is not enough to reconstruct the clinical result.
The single-group design provides no randomized comparator. This limits the ability to distinguish outcomes occurring during the study from outcomes that might have occurred under a different condition. The record also lists masking as NONE. It does not report further detail about outcome assessment procedures or steps, if any, taken to reduce assessment bias.
Further methods needed for a fuller assessment are not reported in the registry record. These include a sample-size justification, a statistical analysis plan, the handling of missing endpoint data, and definitions of the analysis population. The record also does not state how outcomes across time were modeled or whether other outcomes or exploratory analyses were evaluated.
The intervention itself includes both signal recording and algorithm-based stimulation, but the posted primary endpoint is a clinical scale. The record does not report results for technical performance measures, nor does it provide enough information to assess how the system's operation relates to the clinical outcome. Finally, the safety entries are descriptive and lack a control group for comparison. These limitations are specific to what this record reports; they do not establish that unreported analyses or measures were absent from the broader research project.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Tourette Deep Brain Stimulation (DBS) Target Detection & Suppression — NCT05371041.
- Registry record last updated 2026-09-25; status last verified 2026-09.
- Results first posted 2026-09-25.
- 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
The registry record describes a University of Florida single-group device study in Tourette syndrome. It lists 8 enrolled subjects and 8 analyzed subjects, with the Medtronic Percept Neurostimulator as the intervention. The study summary describes a system for recording neural signals and delivering stimulation through a control algorithm, targeting the CM nucleus of the thalamus and the aGPi in each hemisphere.
The primary outcome is the YGTSS Total Tic Score at 9 months. The record lists one outcome measure and zero analyses, but does not report the endpoint result. It lists serious adverse events affecting 3 of 8 at risk, other adverse events affecting 8 of 8 at risk, and 0 deaths. Three serious-event terms are listed, each with 12.5%.
The study has no separate comparator group. Its posted information supports description of the design, endpoint, population, and safety fields, but not an estimate of primary outcome effect or a randomized comparison.