Restoring High Dimensional Hand Function to Persons With Chronic High Tetraplegia: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Restoring High Dimensional Hand Function to Persons With Chronic High Tetraplegia (NCT03482310), a na na study. The primary outcome is Ability to Form Appropriate Grasp Patterns.

2. Clinical Question

The study asks whether a participant with chronic high tetraplegia can use cortical signals to control specified hand grasp patterns through a functional electrical stimulation (FES) system. The participant was described as having a paralyzed arm and hand from spinal cord injury and having received a recording electrode array in the brain as part of the BrainGate study.

The intervention paired a Neuroport cortical recording array with an FES system. The participant was asked to think about holding objects of different shapes; recorded cortical signal patterns were decoded to match the intended grasp shapes. The FES system used implanted electrodes in the arm, shoulder and hand to activate muscles with small electrical currents. The study description says the ability to control grasp patterns was to be assessed both in virtual reality and in the participant’s actual hand.

The primary question was operationalized as the percentage of specified target grasp patterns successfully formed. This is a measure of task performance: it concerns whether the intended grasp pattern was achieved, rather than a broad measure of hand function or independence. The registry record does not report a numerical result for this endpoint, so the extent of success cannot be quantified from the record.

This was a single-group study with enrollment of 1. It therefore addresses performance in the enrolled participant, not a comparative question about outcomes under different treatments or against a control group. The registry record does not report a control condition, a randomized allocation, or a masking procedure. The study’s clinical question is consequently descriptive and participant-specific: what grasp-pattern performance was recorded during the study assessments?

3. Trial Design

The registry identifies this as a single-group study with enrollment of 1. Allocation is listed as NA, and masking is listed as NONE. The record does not describe a randomized comparison or a separate control group. The phase is listed as NA. These details place the study in a descriptive, single-participant setting rather than a conventional parallel-group efficacy comparison.

The study concerns a person with spinal cord injury and chronic high tetraplegia who had a paralyzed arm and hand and had received a brain recording electrode array through the BrainGate study. The stated intervention was use of a Neuroport cortical recording array to determine the desired grasp pattern for an FES system. The arm description says the participant would think about holding different shaped objects and the recorded cortical signal patterns would be decoded to match those grasp shapes.

The record describes FES electrodes implanted in the arm, shoulder and hand, which use electrical currents to activate the relevant muscles. The study description says grasp-pattern control would be examined in virtual reality and in the actual hand. The registry outcome timeframe says assessments occurred on average every 3 months for the full time, identified as 4 years, that the participant was enrolled.

The study start is recorded as 2018-06-01, primary completion as 2023-09-30, and status as COMPLETED. These dates describe the registry milestones; they do not establish when individual assessments occurred. The registry record does not report a protocol rationale for the enrollment target, a sample-size justification, or details of an interim analysis. The planning assumptions described for sample-size illustrations are not evidence that the trial was designed as a two-arm study: the actual registry design is single-group and enrollment was 1.

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 Ability to Form Appropriate Grasp Patterns, measured over Outcomes were assessed on average every 3 months for the full time (4 years) that the participant was enrolled in the study..

The primary endpoint is titled “Ability to Form Appropriate Grasp Patterns.” It measures the success rate for a series of specified grasp patterns, expressed as the percentage of target patterns successfully achieved. The registry describes the reported outcome as a mean with standard deviation over the full assessment period.

This endpoint is used to quantify whether the participant produced the intended grasp patterns during the tasks. It is specific to the study’s central function: decoding cortical signals to select a desired grasp and using FES to activate the muscles needed to form it. The stated assessment setting includes virtual reality and the participant’s actual hand, although the registry record does not report separate endpoint results for those settings.

As a percentage of successful target patterns, the endpoint is a continuous measure. In general, a continuous performance measure can represent gradations in task success rather than reducing performance to a simple yes-or-no outcome for the whole study. The accompanying standard deviation is intended to describe variability in the recorded outcomes during the assessment period; it is not itself a measure of how precisely the mean is estimated.

The registry record defines the endpoint and its timeframe but does not report a numerical mean, standard deviation, assessment count, or setting-specific result. It is therefore possible to explain what the endpoint was intended to measure, but not to state the observed performance level or its variability.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes the primary measure as a continuous outcome: the percentage of target grasp patterns successfully achieved. It also states that the reported outcome is a mean with standard deviation over the assessment period. The record does not list an analysis, and it does not report numerical endpoint results. The following statistical explanations are general; they clarify the kinds of summaries named in the registry, not analyses that can be confirmed as having been performed.

What does the mean describe?

In general, a mean is an average of measured values. For this study, the intended values are success rates for specified grasp patterns. An average can provide a compact description of performance across assessments, but it can conceal changes over time or differences among task types. The registry does not report assessment-level values, task-specific results, or a numerical mean. It is therefore not possible to reconstruct the pattern of performance from the outcome definition alone.

What does the standard deviation describe?

In general, a standard deviation describes how dispersed measurements are around their mean. It characterizes variation among the values included in the summary; it is not the same as a confidence interval and does not directly show the precision of the mean. For repeated observations from one participant, the variation may reflect changing performance across assessments or task conditions, among other possibilities. The registry does not specify how the standard deviation was calculated or report its value. It also does not give enough detail to determine whether different grasp tasks or assessment settings were combined in the same summary.

Why do repeated assessments need care?

General statistical reasoning treats repeated observations from the same participant as potentially related. Measurements close in time or taken under similar conditions may not behave like independent observations. If correlation is ignored, a statistical analysis can misstate uncertainty. The registry describes assessments on average every 3 months over the 4-year enrollment period, but it does not report the actual number or timing of assessments, an approach to within-participant correlation, or a model for change over time. No longitudinal analysis method is reported in the registry record.

What does a confidence interval add?

In general, a confidence interval expresses uncertainty around an estimated quantity under the assumptions of the method used. It is not the same as the range of observed values, which a standard deviation helps describe. A confidence interval for a mean would require an estimate and an analysis that accounts appropriately for the data structure. No confidence interval is reported for the primary outcome, and the registry contains no listed analyses. The uncertainty around the participant’s average performance therefore cannot be quantified from the record.

What does the planning illustration mean?

The stated planning assumptions describe an illustration using 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 stated fraction of the observed effect. Such an illustration is not the design of this single-group study, which enrolled 1 participant. It is not observed power and does not show that the study had a particular probability of detecting an effect. The registry record does not report a sample-size justification for the trial’s own design. The numerical outcome needed to interpret an illustration based on an observed effect is not reported in the registry record.

What can be concluded from the analysis record?

The registry lists 1 outcome measure and 0 analyses. That supports a limited account: an endpoint was defined, but no analysis result is listed. General statistical concepts such as estimation, confidence intervals, and repeated-measures modeling can explain how such data might be analyzed, but they must not be mistaken for methods documented in this study. The registry record does not report a statistical analysis plan, a model, a hypothesis test, an adjustment strategy, or a method for handling missing assessments. Consequently, no inferential conclusion or precision estimate can be recovered from the listed design and endpoint description alone.

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("Cortical Control of Grasp Patterns")
n   <- c(1)
m   <- c(78.75)
sp  <- c(19.1)
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  Cortical Control of Grasp Patterns  1  78.750  19.100  NaN  NaN

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 1 outcome measure and 0 analyses. It identifies “Ability to Form Appropriate Grasp Patterns” as the primary outcome, but it does not report a numerical result. The registry record does not report a statistical analysis plan, a hierarchy of hypotheses, or an approach to multiplicity. It is therefore not possible to determine whether multiple comparisons or outcome definitions were considered in an analysis, or how any such testing would have been handled.

The registry describes assessments on average every 3 months during the full enrollment period, identified as 4 years. It does not report how many assessments were completed, whether any were missing, or how missing observations were handled. The reason for any unavailable assessment, if any, is not reported in the registry record. No assumption about missingness or imputation method can be inferred from the stated assessment schedule.

The record gives no analysis population definition, such as criteria for including observations in the endpoint summary. It does not state whether all scheduled assessments or only completed assessments were used, or how results from virtual reality and actual-hand tasks were combined. Those details are not reported in the registry record.

General statistical practice distinguishes a planned analysis population and missing-data method from the observed data themselves. These choices can affect interpretation, especially for repeated assessments. In this case, the registry supplies neither the necessary methods nor numerical endpoint data. The available record therefore does not support conclusions about multiplicity control, completeness of follow-up, or the sensitivity of the result to missing observations.

12. Safety Results

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

Deaths

Other (non-serious) adverse events

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

The registry lists one participant at risk for serious adverse events and reports 0 affected. For other adverse events, it also lists one participant at risk and 0 affected. Deaths are reported as 0. These figures describe the registry’s recorded counts; they should not be read as evidence about events beyond the recorded study information.

The record does not list serious adverse-event terms. It also does not describe event definitions, severity grading, relatedness assessment, event timing, or the period over which each category was monitored. Those details are not reported in the registry record. The adverse-event counts therefore cannot be used to characterize the nature of potential events or to compare safety with another group.

In general, “at risk” identifies the number of participants represented in the relevant safety accounting, while “affected” indicates the number recorded as experiencing an event in that category. With enrollment of 1, the counts concern the single participant in this study. They do not provide a rate estimate that can be generalized reliably to a wider population, and the registry record does not provide a comparison group.

The reported zeros should be stated narrowly: the registry records 0 affected for serious and other adverse events and 0 deaths. They do not establish that every possible event was assessed or that the intervention is free of risk. The event-level details and reporting procedures needed for a fuller safety interpretation are not reported in the registry record.

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

The record documents a completed, single-group study with enrollment of 1, focused on using decoded cortical signals to select grasp patterns and FES to activate hand and arm muscles. It defines a primary measure based on the percentage of target grasp patterns successfully achieved and gives an assessment timeframe. These details explain the study’s intended question and how performance was to be expressed.

The record does not report the numerical primary outcome. Consequently, it does not show the participant’s average grasp-pattern success, the variability of that outcome, or how results differed between virtual reality and actual-hand assessments. It also does not report assessment-level results or a trend over time. Without numerical outcome data, the degree of performance cannot be described or evaluated for precision.

The study has no listed control group and no randomized allocation. Its registry record therefore does not provide a comparison that can separate the observed performance from what might have occurred under another condition. The record lists no analyses, so it also gives no reported hypothesis test or inferential estimate. The findings cannot be interpreted as a comparative treatment effect.

The enrollment of 1 means the study’s design is centered on an individual participant. Even a complete numerical result would describe that participant’s performance under the study conditions; by itself, it would not establish expected performance in other people. The registry record also does not report information needed to assess how representative the participant or assessment experience may be.

The safety entries report 0 affected for serious and other adverse events and 0 deaths among one participant at risk. They are limited registry counts, without event-level descriptions or a comparison group. The study status, COMPLETED, indicates the registry’s status entry, not that a result has been reported. The most defensible interpretation is that the registry documents a specific research question and endpoint, while the primary numerical result and analysis are not reported in the registry record.

14. Why This Trial Matters Statistically

This trial is statistically distinctive because its registry design is a single-group study with enrollment of 1, while its primary endpoint is a repeated performance measure. That combination calls for a clear distinction between an individual’s repeated observations and evidence about variation across participants. Repeated assessments can describe an individual’s experience over time, but they do not substitute for a sample of participants when the question concerns variation across a broader population.

The endpoint is tied closely to the task: the proportion of specified grasp patterns successfully formed. A measure framed in this way can make the study question concrete, but its interpretation depends on details such as which patterns were tested, how success was defined, and whether settings were summarized separately. The registry describes the broad endpoint and mentions virtual reality and actual-hand assessment, but those operational details and setting-specific results are not reported in the registry record.

The stated timeframe also matters statistically. Assessments were described as occurring on average every 3 months throughout 4 years of enrollment. A summary across that period could conceal a changing pattern. Reporting assessment-level results or a clearly described longitudinal analysis would address a different question from a single overall average; the registry record does not report either.

The design also highlights why planning illustrations must be distinguished from observed evidence. The stated sample-size assumptions describe a hypothetical two-arm calculation, whereas the registry describes a single-group study. Such an illustration is not the trial’s design and is not observed power. No sample-size justification for this study is reported in the registry record.

Finally, the record distinguishes an outcome definition from an outcome result. A clearly named endpoint cannot answer how well the task was performed without the numerical estimate and its uncertainty. The missing result limits statistical interpretation even though the design and question are described.

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.

The most direct limitation for interpreting this trial is that the registry record does not report a numerical result for the primary endpoint. Although the endpoint is defined as a percentage of target grasp patterns successfully achieved and the summary is described as a mean with standard deviation, neither value is reported. No confidence interval or assessment-level data are reported.

Enrollment was 1, and the study is listed as single-group. This means the registry record cannot provide a between-group comparison or an estimate of variation across participants. Allocation is NA and masking is NONE. There is no reported control condition against which to interpret performance.

The assessment timeframe is described as an average frequency of every 3 months across the 4-year enrollment period, but the record does not give the number of completed assessments, their exact dates, or their individual outcomes. It does not report whether virtual-reality and actual-hand results were analyzed separately. Any change over time, consistency across tasks, or difference by setting is therefore not available for interpretation.

The record lists 0 analyses and does not report a statistical analysis plan, a method for repeated observations, or a method for missing data. It does not define an analysis population or explain how the mean and standard deviation were calculated. The reason for any missing assessments, if any, is not reported in the registry record.

Safety interpretation is also limited: the registry reports no affected participants in the serious or other adverse-event categories and no deaths, but it does not provide event-level terms or monitoring details. These constraints mean that the registry record supports a description of the study framework, not a detailed assessment of efficacy, precision, longitudinal change, or safety.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Restoring High Dimensional Hand Function to Persons With Chronic High Tetraplegia — NCT03482310.
• Registry record last updated 2026-02-20; status last verified 2026-02.
• Results first posted 2026-02-20.
• 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

The registry record describes NCT03482310, “Restoring High Dimensional Hand Function to Persons With Chronic High Tetraplegia,” sponsored by the VA Office of Research and Development. The study is listed as COMPLETED, with a start date of 2018-06-01, primary completion date of 2023-09-30, and enrollment of 1.

It is a single-group study with allocation listed as NA and masking as NONE. The intervention uses a Neuroport cortical recording array to determine intended grasp patterns for an FES system. The primary endpoint is the percentage of specified target grasp patterns successfully achieved, summarized as a mean with standard deviation over the assessment period. Assessments were described as occurring on average every 3 months during the participant’s 4-year enrollment.

The registry reports 1 outcome measure and 0 analyses. It does not report a numerical primary outcome result. Safety entries list one participant at risk and 0 affected for serious and other adverse events, with 0 deaths; serious-event terms are not listed. The record does not report a control-group comparison, a statistical analysis plan, or methods for missing data.