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 Reanimation in Tetraplegia (NCT01997125), a na na study. The primary outcome is Number of Participants With Voluntary Movement.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01997125 |
| Phase | NA |
| Condition | Spinal Cord Injury (Quadraplegia) |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 1 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Marcia Bockbrader |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns a participant with tetraplegia, described in the registry condition as spinal cord injury (quadraplegia). Enrollment was 1. The registry record does not report further eligibility or participant characteristics.
Intervention
The intervention is the Neural Bridge System, a device. The arm description refers to a neural bridge system implant and external stimulator. The study’s stated purpose is to investigate whether the system can enable a paralyzed limb to move under voluntary control by the participant’s thoughts.
Comparator
This is a single-group study with an open-label arm. Allocation is listed as NA, and the registry record does not describe a control group. There is therefore no like-for-like comparison against another treatment or a control condition in the record.
Primary question
The primary outcome asks how many participants achieve voluntary hand movement using the neural bridge system. It is assessed over a timeframe of 9 months. The registry record does not report the observed result for this outcome.
The clinical question is exploratory and device-focused: whether voluntary hand movement is achieved with the neural bridge system in the study participant. The record’s wording connects that movement to the participant’s thoughts and identifies restoration of cortical control of functional movement as the broader aim. These descriptions establish the study’s intended question, but they do not establish that the endpoint was achieved.
With enrollment of 1 and no control group described, the record cannot establish how the outcome compares with what would have happened without the device or with another intervention. It also does not report participant characteristics or an outcome result, so the clinical question cannot be answered from the posted information alone.
3. Trial Design
The registry describes Reanimation in Tetraplegia as a completed, single-group study. Enrollment was 1. The intervention is the Neural Bridge System, categorized as a device, and the arm is described as open label, with a neural bridge system implant and external stimulator. Masking is listed as none, while allocation is listed as NA. Phase is also listed as NA.
The study start is recorded as 2013-11 and primary completion as 2019-06-13. Its status is completed. Those registry dates describe the study record; they do not establish when a participant received the intervention, how long follow-up lasted in practice, or whether the primary outcome was assessed as planned. The primary outcome timeframe is stated as 9 months.
The design is not a randomized comparison. The record lists one group and provides no control arm, so the study is not set up in the registry to estimate a comparative treatment effect between groups. Its structure is suited to describing the experience and outcome of the enrolled participant, rather than separating an intervention effect from other possible explanations.
The registry identifies Marcia Bockbrader as sponsor. It does not report a detailed protocol, eligibility criteria, recruitment approach, or a statistical analysis plan. It also does not report a sample-size justification. The record’s completion status should not be treated as evidence that every planned assessment was available or that the primary endpoint was attained: the primary outcome result 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 | Neural Bridge System - Open Label |
|---|---|
| STARTED | 1 |
| COMPLETED | 1 |
| NOT COMPLETED | 0 |
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 | Neural Bridge System - Open Label |
|---|---|---|
| Participants analysed | 1 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 0 |
| Sex: Female, Male: Male | Participants | 1 |
| 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 | 1 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 1 |
| Number of participants with voluntary movement: Evoked movement - able | Participants | 0 |
| Number of participants with voluntary movement: Evoked movement - unable | Participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Voluntary Movement, measured over 9 months.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is “Number of Participants With Voluntary Movement.” Its unit is participants, and its description identifies achievement of voluntary hand movement using the neural bridge system as the outcome. The stated timeframe is 9 months. This is a binary, participant-count outcome: each participant would be classified according to whether the specified movement outcome was achieved, and the result would be expressed as a count.
The endpoint is relevant to the study’s stated objective because it addresses whether voluntary hand movement is achieved with the device. It is a direct description of the intended functional outcome, rather than an indirect measure such as a laboratory marker. The registry does not specify the operational criteria used to decide that movement had been achieved, how the assessment was performed, or who assessed it. Those measurement details are not reported in the registry record.
The endpoint’s planned timeframe does not by itself show that an assessment was completed at that time. The registry record does not report an observed count or an outcome result. Consequently, the endpoint can be described, but its achievement cannot be determined from the posted record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study’s design and stated outcome, but it does not report the primary endpoint result. The primary question concerns the number of participants who achieve voluntary hand movement using the neural bridge system over 9 months. Enrollment was 1, yet no outcome count is reported. The status is completed, but completion status does not substitute for the missing endpoint result.
The study is single group and open label, with no masking and no control group listed. Accordingly, the registry does not support a treatment-versus-control estimate. Even if an outcome count were posted, an observation in one participant would be descriptive of that participant’s recorded experience; without a comparison group, it would not by itself quantify what would have occurred under another condition. This limitation concerns the design, not whether the outcome is important to the study’s objective.
No analysis is listed in the registry record. There is therefore no reported statistical estimate, confidence interval, or hypothesis test for the primary outcome to interpret. In general, a confidence interval expresses uncertainty around an estimate under specified assumptions. Without a posted estimate and analysis, there is no registry-based interval with which to assess precision. The record does not report a statistical analysis plan, so the intended inferential approach is not reported in the registry record.
The safety information is also limited in scope. The record lists one participant at risk and one affected for serious adverse events, and identifies “Unanticipated, device-related SAE” with 100.0%. It lists 0 deaths. These entries describe the registry’s safety reporting; they do not establish the nature, timing, severity details, or clinical consequences of the event beyond the reported term. The label “device-related” is part of the listed event term, but the record does not supply further adjudication details.
Overall, the posted information supports a clear account of the study question and its single-group design, but not a conclusion about whether voluntary hand movement occurred or how precisely any effect was estimated. The primary result and analysis are not reported in the registry record. Interpretation should therefore remain descriptive and limited to the information actually recorded.
9. Statistical Methods Explained
The record describes a single-group study with a binary primary outcome, expressed as a count of participants who achieve voluntary movement. No analysis is listed. The statistical methods used for the primary outcome are therefore not reported in the registry record. The explanations below describe general statistical principles relevant to this outcome, rather than methods confirmed as having been used in this study.
What does a binary participant-count outcome mean?
General: A binary outcome places each participant into one of two categories, such as whether a predefined event or achievement occurred. A participant count reports how many people met the outcome. To interpret a count fully, readers generally need to know the number assessed, the outcome definition, and how missing or unevaluable assessments were handled. The registry gives enrollment of 1 and describes the outcome, but does not report the observed outcome count or assessment details.
General: A count and a proportion answer related but distinct descriptive questions. A count states how many participants had the outcome; a proportion relates that count to the number assessed. No proportion is reported for the primary outcome in the registry record, and no new proportion can be inferred without the endpoint result and a clear analysis population.
What can a single-group design estimate?
General: A single-group study can describe outcomes observed among participants receiving an intervention. It does not provide a concurrent control group for estimating a contrast between intervention and control. An outcome observed after an intervention may be relevant to the study’s objective, but the design alone does not separate the intervention’s contribution from other explanations. The record lists a single group and no control comparison.
General: Random allocation, when used, helps create comparable groups in expectation, while masking can reduce some forms of assessment or reporting influence. This study’s allocation is listed as NA and masking as none. Those design features matter when interpreting any observed outcome, but the registry does not report an outcome result to evaluate.
How should uncertainty be considered?
General: Statistical uncertainty describes how much an estimate may vary across repeated samples under a specified model and set of assumptions. A confidence interval is one way to express that uncertainty around an estimate. It does not remove limitations in study design or measurement. When the number of participants is very small, estimates can be especially sensitive to the experience of each participant. Here, enrollment was 1, and the primary result and an interval are not reported.
General: A hypothesis test addresses a specified statistical question under stated assumptions. Its result depends on the endpoint, analysis population, model, and testing plan. No primary analysis or analysis plan is listed in the registry record, so there is no reported test result to interpret. Statistical significance, even if it had been reported, would not by itself establish clinical importance or resolve the limitations of a single-group design.
What do the planning assumptions represent?
The registry’s planning description characterizes sample-size calculations as illustrations based on an observed effect, not as the trial’s own design. It describes 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. The description also distinguishes between planning outputs expressed per arm and those expressed as a total number of events for time-to-event settings.
Those assumptions are planning conventions, not observed study results. In particular, equal allocation between two arms does not describe the listed single-group study. The registry does not report a trial-specific sample-size justification, and no observed primary effect is reported in the record. The planning description therefore cannot be read as evidence that this study enrolled enough participants, had a particular power, or achieved a particular effect. Any sample-size illustration is a planning scenario, never observed power.
Why does outcome definition matter?
General: A reproducible endpoint needs clear rules for what counts as an event or achievement, when it is assessed, and how disagreements or incomplete assessments are treated. Such details help readers judge measurement reliability and compare results across studies. The record states that the outcome is achievement of voluntary hand movement using the neural bridge system and gives a 9-month timeframe, but the operational definition and assessment procedure are not reported in the registry record.
In short, the registry permits identification of the endpoint type and study structure, but not reconstruction of the statistical analysis. The primary result, uncertainty estimate, analysis population, missing-data approach, and statistical plan are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 1 outcome measure and 0 analyses. It identifies one primary outcome: the number of participants with voluntary movement. The record does not report whether additional outcomes were prespecified elsewhere, whether any formal testing was planned, or whether an approach to multiplicity was specified. A multiplicity procedure is not reported in the registry record.
General: Multiplicity arises when several outcomes, time points, subgroups, or statistical tests are considered. Repeated testing can increase the chance of at least one apparently unusual result under a null hypothesis. How to address that issue depends on the prespecified questions and analysis plan. The registry’s count of one outcome measure does not establish that no other analyses were planned outside the posted record.
The analysis population is not reported in the registry record. The record does not explain whether all enrolled participants were intended to be included in the primary analysis, what would happen if an assessment were unavailable, or how missing outcome data would be handled. Enrollment was 1, but that does not show how many participants had an evaluable 9-month assessment. The observed primary outcome result is also not reported.
These omissions limit assessment of whether the primary outcome was analyzed as intended and whether any missing-data or multiple-testing decisions could affect interpretation. The registry record does not report an analysis plan from which those decisions can be checked.
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 |
|---|---|---|---|
| Open Label | 1 | 1 | 100.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Open Label | 0 of 1 |
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 |
|---|---|
| Open Label | 1 of 1 |
Most frequent serious adverse event terms
| Event term | Organ system | Open Label |
|---|---|---|
| Unanticipated, device-related SAE | General disorders | 1 of 1 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Open Label |
|---|---|---|
| Non-device related AE associated with spinal cord injury (anticipated) | Skin and subcutaneous tissue disorders | 1 of 1 |
| Non-device related AE associated with spinal cord injury (anticipated) | Renal and urinary disorders | 1 of 1 |
Serious events with the highest arm-level rate: unanticipated, device-related sae (100.0%).
The registry lists one participant at risk for serious adverse events and one affected. The listed serious-event term is “Unanticipated, device-related SAE” at 100.0%. Deaths are listed as 0. These figures describe the safety entries in the registry record; they do not provide a full account of event timing, duration, clinical details, or outcome.
The 100.0% figure is attached to the listed serious-event term. It should be read as a registry-reported percentage, not as a measure of event severity or a comparative risk estimate. With a single participant enrolled, the entry describes the recorded experience of that participant and cannot establish how frequently such events would occur in a broader population. There is no control group listed for a safety comparison.
The term includes the words “device-related,” but the record does not report further information about how relatedness was assessed or whether an independent review occurred. The listing does not, on its own, show whether the event was resolved or what consequences followed. The absence of deaths in the registry entry does not mean that no serious adverse event occurred; the record separately lists a serious adverse event affecting the participant.
12. What the Result Does, and Does Not, Mean
The registry record identifies a completed study of the Neural Bridge System in tetraplegia and states a primary question about achievement of voluntary hand movement. It also identifies the intervention as an implant and external stimulator in an open-label, single-group design. These details explain what the study was intended to investigate.
The record does not report the primary outcome result. It therefore does not establish whether voluntary hand movement was achieved, how many participants achieved it, or how precise an estimate might be. Completion status is not an outcome finding. The study’s stated purpose is likewise not evidence that the device achieved the intended movement.
The design also limits what could be concluded from an observed result. With one group and no control listed, the record cannot provide a randomized comparison or establish how the outcome differs from an alternative. Enrollment of 1 makes the study a record of a single participant’s experience, rather than a basis for estimating outcomes across a broad population. The registry does not report enough participant detail to assess how closely that experience may apply to others.
The safety entries report one participant at risk and affected for serious adverse events, the term “Unanticipated, device-related SAE” at 100.0%, and 0 deaths. These entries should be read as reported safety information, not as a complete account of safety or a comparative estimate.
In general, a study can be informative about feasibility, outcome definitions, and issues encountered during investigation without supporting broad effectiveness or safety conclusions. The posted record supports description of the research question and design, but the missing primary result and analysis prevent assessment of the endpoint itself. Conclusions about what happened to the participant or what the device may do beyond this record are not established by the registry information.
13. Why This Trial Matters Statistically
Statistically, the key feature of this record is the gap between a clearly stated binary endpoint and the absence of a reported endpoint result. The study asks whether voluntary hand movement is achieved, a question that can be expressed as a participant count. Yet the registry does not report that count or an analysis. Readers can identify what the investigators intended to assess, but cannot quantify the outcome from the posted record.
The single-group design is also central. It makes the study descriptive rather than a like-for-like randomized comparison, as no control group is listed. This distinction affects the type of inference available: an observed outcome could describe the enrolled participant, but would not by itself establish a comparative effect. Enrollment of 1 further means the record concerns one participant’s experience and cannot alone characterize outcomes across a larger population.
The record illustrates why endpoint definition, assessment reporting, and analysis transparency matter. It names voluntary hand movement and gives a 9-month timeframe, but does not report the operational criteria, assessment procedure, analysis population, missing-data handling, or statistical plan. Without those details and the result, readers cannot examine how the outcome was measured or how uncertainty was handled.
The safety entries are likewise important to interpret in context. A serious adverse event is listed for the participant, alongside 0 deaths, but the record gives limited event detail and no comparator. These registry entries warrant accurate description without implying a population-level risk estimate.
The statistical importance of the record lies in distinguishing a research objective from evidence about its result. A completed study record can define a question and document design and safety entries, while still leaving the primary outcome unreported. That distinction prevents intentions, design labels, or planning assumptions from being mistaken for an observed finding.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several limitations are specific to the registry information for this study. Enrollment was 1, and the design is listed as single group, with allocation NA and no masking. There is no control group described. These features limit the record’s capacity to support comparative conclusions and make any single-participant observation unsuitable as a stand-alone estimate for a broader population.
The primary endpoint is named and assigned a 9-month timeframe, but its observed result is not reported. The registry does not report the operational criteria for voluntary hand movement, the assessment process, or who judged whether the endpoint was achieved. Without those details, measurement reproducibility and interpretation cannot be assessed from the record.
The registry also does not report participant characteristics beyond the stated condition and enrollment. It does not provide the analysis population, missing-data approach, statistical analysis plan, or trial-specific sample-size justification. No analysis is listed. As a result, the record does not permit review of how the primary outcome was analyzed or how uncertainty was characterized.
The safety entries are limited: one participant is listed at risk and affected for serious adverse events, with “Unanticipated, device-related SAE” recorded at 100.0% and 0 deaths. Details about the event and its assessment are not reported in the registry record. These data cannot characterize the frequency or nature of safety outcomes in a larger group.
Finally, the planning assumptions describe a hypothetical two-arm calculation, while the registered design is single group. Those planning assumptions should not be treated as the study’s design or as evidence about its observed results. The registry record does not report enough information to resolve these limitations.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Reanimation in Tetraplegia — NCT01997125.
- Registry record last updated 2021-08-31; status last verified 2021-08.
- Results first posted 2021-07-09.
- 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
Reanimation in Tetraplegia is listed as a completed, single-group, open-label device study with enrollment of 1. The intervention is the Neural Bridge System, described in the arm as an implant and external stimulator. The registry lists no masking and allocation as NA.
The primary outcome is the number of participants achieving voluntary hand movement using the system, with a 9-month timeframe. Its result and a statistical analysis are not reported in the registry record. The record lists one participant at risk and affected for serious adverse events, the term “Unanticipated, device-related SAE” at 100.0%, and 0 deaths. It does not report a control group, analysis plan, or trial-specific sample-size justification.