Evaluation of a Millimeter Wave Emission Bracelet for Improving Parkinson's Disease Symptoms: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluation of a Millimeter Wave Emission Bracelet for Improving Parkinson's Disease Symptoms (NCT04648150), a randomized na study. The primary outcome is Assessment of the Effectiveness of Two Months of Use of the Remedee Endorphin Band Medical Device in Improving Motor Disorders in Patients With Parkinson's Disease.

2. Clinical Question

The registry rationale describes Parkinson disease as involving motor and non-motor symptoms and presents the bracelet as a less invasive, less expensive device approach. It proposes that millimeter-wave stimulation of subcutaneous nerve endings may lead to a physiological response involving endorphins. That description is a rationale for investigating the device, not evidence from this trial that the proposed pathway occurred. The posted primary endpoint concerns motor-score change, rather than endorphin release or the full range of Parkinson disease symptoms.

3. Trial Design

The registry describes a multicenter, double-blind randomized controlled trial. Its design fields list randomized allocation, triple masking, and a parallel model. Enrollment was 60 participants, and the posted arm counts are 30 assigned to VERUM and 30 to SHAM. The registry record does not identify which participant, investigator, assessor, or other roles were included in the masking description, nor does it report details of the randomization procedure.

The primary endpoint was assessed two months after inclusion. During the first two months, one group used an active wave-emission bracelet and the other an inactive bracelet. The MDS-UPDRS III assessment was specified to occur under ON Dopa conditions and blinded from the randomization arm. The registry describes different device use after month two: the VERUM group received a second active medical device for four months, while the SHAM group was to receive an active device from month two to month six. The primary comparison therefore concerns the initial two-month period; the later device schedule does not change the stated timing of that primary outcome.

The record lists the study as completed, with a start date of 2021-05-18 and primary completion date of 2023-05-05. It lists Fondation Ophtalmologique Adolphe de Rothschild as sponsor. The phase is recorded as not applicable. The registry record does not report the trial's original sample-size justification, detailed protocol procedures, or the precise responsibilities of the masked parties. Although a planning illustration is available based on the observed effect, that illustration is not a description of the trial's original design assumptions.

The published outcome information in the record includes one primary outcome measure and no posted secondary outcomes. It also lists zero analysis entries. Thus, the reported counts and comparative statistics can be described, but a complete account of the analysis plan or of any analyses beyond the posted results is not available 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

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 Assessment of the Effectiveness of Two Months of Use of the Remedee Endorphin Band Medical Device in Improving Motor Disorders in Patients With Parkinson's Disease, measured over two months after inclusion.

The primary endpoint counts participants whose MDS-UPDRS III score decreased by at least 3.25 points from inclusion. The assessment was scheduled for two months after inclusion, performed under ON Dopa conditions, and described as blinded from the randomized group. MDS-UPDRS III is a measure of motor disorders; its range is 0 to199, with higher scores indicating a worse outcome. The endpoint converts change on that scale into a binary outcome: a participant either meets the specified decrease threshold or does not.

A threshold-based endpoint can make a result easier to express as a count of participants meeting a defined criterion. It also discards some detail: participants with different score changes may fall on the same side of the threshold, and participants near the cutoff may be classified differently despite similar changes. The endpoint therefore answers a focused question about reaching the stated decrease, rather than describing the full distribution of score changes. The registry does not report the rationale for selecting 3.25 points, whether that threshold was established in advance in the protocol, or the individual score changes underlying the counts.

The posted counts are 6 participants in VERUM and 13 in SHAM. They indicate how many participants met the endpoint definition in each arm, not the average change in score. The registry outcome is expressed as a participant count, and no dispersion measure or score-change summary is posted. The endpoint is specific to motor symptoms as assessed by MDS-UPDRS III; it does not directly measure the non-motor symptoms mentioned in the study rationale.

7. Results Posted in the Registry

• VERUM: 20.0% (6/30) versus 43.3% (13/30) on control; risk difference -23.3 percentage points (95% CI -46.1 to -0.5), risk ratio 0.46 (0.20–1.05); unadjusted two-proportion z-test p = 0.052.

8. Statistical Interpretation

9. Statistical Methods Explained

For a binary endpoint, each participant is classified according to whether the defined event occurred. Here, the event is meeting the stated decrease threshold on MDS-UPDRS III. The reported group counts are 6 of 30 for VERUM and 13 of 30 for SHAM. The arm-specific proportions displayed with the comparison are 0.2 and 0.433, respectively. A difference in proportions expresses the absolute contrast between groups; it is negative when the event proportion in VERUM is lower than in SHAM. The posted risk difference is -0.233.

What does the risk difference express?

The risk difference keeps the comparison on the event-proportion scale. Its estimate of -0.233 represents a lower observed proportion meeting the endpoint in VERUM than in SHAM. The confidence interval, from -0.461 to -0.005, gives a range of values compatible with the data under the method used to construct it. A confidence interval is not a probability statement that the true value lies within the particular interval. Its interpretation depends on the sampling model and method, which are not identified in the registry record.

Absolute differences are often useful because they retain the scale of the endpoint. However, an absolute contrast does not describe the full pattern of score changes, and its magnitude can depend on the underlying event frequency. In this trial, the event is not a general adverse event: it is meeting the specified motor-score decrease threshold. Interpret the risk difference as a contrast in the proportion meeting that criterion.

How do the relative measures differ?

The registry also reports a risk ratio and an odds ratio. The risk ratio compares the two event proportions as a quotient; its displayed estimate is 0.462, with an interval from 0.202 to 1.053. A value of 1 corresponds to equal event proportions. The odds ratio compares event odds rather than proportions; its estimate is 0.327, with an interval from 0.103 to 1.032. A value of 1 on that scale likewise corresponds to equal odds. The two measures are not numerically interchangeable. Odds ratios can be less intuitive than risk differences, and their interpretation should remain tied to the endpoint and group counts rather than being described as a change in probability.

Both relative-measure intervals include 1. The risk-difference interval lies below zero, while the posted p-value is 0.052. These summaries may be based on distinct procedures, but the procedures are not specified. No particular test, interval construction, adjustment, or model should therefore be inferred from the reported estimates alone. The registry record does not report the statistical analysis plan or the method used to derive these inferential quantities.

What does the p-value tell the reader?

The displayed p-value of 0.052 is a measure of how unusual data at least as incompatible with a specified null model would be, if that model and the analysis assumptions held. It is not a probability that the device has an effect, and it does not quantify the size or importance of the observed contrast. Its meaning depends on the test and assumptions, which are not reported. It should be read alongside the effect estimate, confidence intervals, endpoint definition, and sample size, rather than used as a stand-alone verdict.

The registry record does not specify a threshold for declaring a result statistically significant in the trial's own analysis plan. A two-sided significance level of 0.05 appears among the assumptions for the separate planning illustration, but that does not establish the trial's original inferential threshold. The displayed p-value and confidence intervals should be quoted as separate posted results, not reconciled by assuming an unreported method.

Why does over-dispersion matter in some analyses?

General statistical explanation: in count-data models, over-dispersion means that observed variability is greater than the model's assumed variability. If it is ignored, uncertainty can be understated and intervals or tests can appear more decisive than warranted. That issue is not directly assessed by the posted binary endpoint summaries, and the registry record does not report a count-data model. The general concept is included to distinguish model assumptions from the observed counts; it should not be taken to imply that over-dispersion was present in this trial.

The endpoint's binary form also has limitations. It classifies participants around a cutoff and does not retain all information about the magnitude of their score changes. A change just short of the threshold is grouped with no decrease meeting the criterion, while a change meeting the threshold is counted as an event. The registry record does not provide the continuous score-change data needed to examine the distribution, or information about whether alternative endpoint definitions were analyzed.

Finally, the record lists zero analysis entries. The reported estimates can be described, but the analysis population, handling of missing scores, and any adjustment for other variables are not reported in the registry record. Those details matter because they affect how a trial estimate relates to the randomized groups and how uncertainty should be understood.

10. Confidence Intervals and Precision

The confidence intervals show that the trial's estimated contrasts are imprecise. For the risk difference, the point estimate is -0.233 and the interval runs from -0.461 to -0.005. This range is broad relative to the point estimate and remains below zero as reported. It indicates that the posted estimate is not an exact measure of the contrast, even though the interval's upper endpoint is close to zero.

The relative measures add another view of precision. The risk ratio is 0.462, with an interval from 0.202 to 1.053; the odds ratio is 0.327, with an interval from 0.103 to 1.032. Both intervals include 1, the no-contrast value on those scales, and extend across a broad range of possible relative effects. The values should not be converted into claims about the probability of a true effect. They describe uncertainty around estimates under methods that the registry does not identify.

The equal arm counts of 30 and the event counts of 6 and 13 give context for this uncertainty. With relatively few participants meeting the endpoint, each observed outcome contributes appreciably to the group proportions. The available summary does not include the individual observations or score-change distribution, so precision for other ways of summarizing the motor scores cannot be assessed.

There is also a difference between the displayed risk-difference interval and the displayed unadjusted p-value of 0.052 in how they might be read under familiar procedures. Since the registry record does not report the interval or test method, neither should be substituted for the other or silently recalculated. The confidence intervals and p-value are best presented as the separate reported summaries, with their methodological uncertainty acknowledged.

11. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size figures are planning illustrations, not the trial's observed sample size or a report of its original design calculation. The figures are participants per arm for equal allocation. They are based on the observed effect, with the target effect varied to represent 100%, 75%, or 50% of that observed effect. For each target, the illustration gives the participants per arm for 80% power and for 90% power. The 80% column describes a design intended to have an 80% chance of detecting the specified effect under the stated assumptions if that effect is real; the 90% column describes the corresponding 90% chance. These are design properties under a model, not guarantees for a future study.

The listed assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is the stated fraction of the observed effect. Under those assumptions, the displayed requirements are 62 participants per arm for 80% power and 82 for 90% power when planning for 100% of the observed effect; 115 and 154 when planning for 75%; and 270 and 360 when planning for 50%. Smaller target effects require more participants to distinguish them from random variation with the same planned power. The curve should be read as a visual expression of this relationship, not as evidence about the effect actually present.

This is not observed power. The registry's original sample-size assumptions and justification are not reported in the registry record. The illustration is calculated from the observed effect, so it is a retrospective planning aid and should not be interpreted as a measure of how likely the completed trial was to detect an effect.

12. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.433; treatment proportion p₁ = 0.200; average p̄ = 0.317.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.6579 = 1.2894.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.6368 = 0.5360.
4. n = (1.2894 + 0.5360)² / (-0.2333)² = 61.2, rounded up to 62 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
p0 <- 0.433333333333333                          # control proportion
p1 <- 0.2                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(4648150)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 62 (80% power), 82 (90% power)
 75% of observed effect: n per arm = 115 (80% power), 154 (90% power)
 50% of observed effect: n per arm = 270 (80% power), 360 (90% power)
power.prop.test: 61.2 
Simulated power at n = 62 per arm: 0.813 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

13. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary outcome measure and no posted secondary outcomes. It also lists zero analysis entries. The record therefore does not establish whether the study assessed additional outcomes or conducted analyses that were not posted. It does not report a multiplicity strategy, such as a prespecified hierarchy or adjustment for multiple comparisons. With no secondary results listed, multiplicity cannot be evaluated from the posted outcome information alone.

Missing-data handling is also not described. The outcome counts list 30 participants in each arm, but the record does not say whether those numbers represent all randomized participants with observed endpoint data, whether any scores were unavailable, or how unavailable outcomes were treated. It does not report imputation, sensitivity analyses, or reasons for missing assessments. The absence of those details means the effect of missing data on the comparison cannot be judged from the registry record.

The analysis population is not reported in the registry record. In particular, the record does not specify whether the estimates use all randomized participants, participants who completed the assessment, or another defined group. It also does not describe protocol deviations or how they were handled. Random allocation helps create comparable groups at the start of a trial, but interpretation of the resulting estimate still depends on how the randomized groups and outcome data are analyzed.

The trial is described as triple masked, and the primary assessment is described as blinded from the randomization arm. The registry does not identify the masked roles or report whether masking was assessed. These omissions do not prove that the trial lacked such procedures; they mean that the posted record does not give enough detail to evaluate them. A more complete protocol and statistical analysis report would be needed to assess these aspects of the analysis.

14. 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 5% reporting threshold.

The registry reports serious adverse events for 0 of 30 participants at risk in VERUM and 0 of 30 at risk in SHAM. It also reports other adverse events for 0 of 30 participants at risk in each group, and deaths for 0 participants in each group. No serious adverse-event terms are listed.

These figures describe the adverse-event counts posted for the trial; they do not establish that no adverse events of any kind occurred outside the recorded categories or reporting period. The registry record does not provide detailed definitions, collection procedures, event-level descriptions, or follow-up duration for safety reporting. The posted zeros should therefore be read as no events reported in these listed categories, not as proof that the device is free of risk.

The risk denominators are 30 per group. With no reported events in either arm, the data do not allow a comparative estimate of event risk between groups. The absence of reported events also does not demonstrate equivalence or exclude uncommon events. The registry does not provide information that would support a more detailed safety assessment.

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

The posted result answers a narrow question: how many participants in each randomized group met a specified threshold for a decrease in MDS-UPDRS III at the two-month assessment? The counts are 6 of 30 in VERUM and 13 of 30 in SHAM. The displayed risk difference of -0.233 describes a lower observed proportion meeting that endpoint in VERUM, while the confidence intervals and p-value reflect uncertainty in the comparison. These results do not establish a broader change across all Parkinson disease symptoms.

The endpoint captures whether a participant crossed a score-change threshold. It does not show the average change in motor score, the amount of change for each participant, or whether people just above and just below the cutoff had meaningfully different experiences. The posted results also do not report effects on sleep, cognition, pain, or the other non-motor concerns mentioned in the study rationale.

The trial's rationale describes a possible relationship between millimeter-wave stimulation, endorphins, and physiological pathways. The posted primary endpoint does not measure those processes. The result therefore cannot show that the proposed mechanism occurred, nor does the record establish that any observed score changes were caused by the proposed pathway.

The outcome is assessed at two months. It does not establish what happened after that assessment or whether any change was sustained. Although the registry describes device use through month six, the posted primary endpoint and comparison are at two months, and no later outcome results are listed. The record also does not report secondary outcomes, missing-data handling, or the analysis population.

Finally, a trial result should not be converted into individual treatment guidance. The posted counts and estimates describe this randomized comparison as recorded; they do not determine what an individual should do. The uncertainty in the estimates, limited outcome detail, and missing analysis information are important parts of interpreting the result.

16. Why This Trial Matters Statistically

This trial illustrates how endpoint definition shapes the statistical question. The primary outcome is not the mean MDS-UPDRS III change; it is a count of participants crossing a prespecified-looking threshold of a 3.25-point decrease. That makes the result easy to express as group counts and proportions, but it omits the magnitude and distribution of score changes. The registry does not report the threshold's rationale or the underlying continuous data, so readers cannot assess how results would look under other summaries.

It also shows why an estimate and its uncertainty should be read together. The point estimate for the risk difference is -0.233, and the interval is wide, while the relative-measure intervals include the no-contrast value. The posted p-value is 0.052, and the methods behind the inferential summaries are not specified. Statistical interpretation is therefore not reducible to a single cutoff or a single measure. Different scales highlight different aspects of the same counts.

The trial's total enrollment of 60 and equal arm counts are relevant context for precision. The planning illustration demonstrates how desired power and assumptions about the target effect can change sample-size requirements; smaller effects need more participants. But because that illustration is based on the observed effect rather than the original design, it cannot explain why this trial enrolled its particular number of participants.

Finally, the record draws attention to reporting completeness. No analysis entries or secondary outcomes are posted, and key details about the analysis population, missing data, multiplicity, and inferential methods are not reported in the registry record. These are not merely technical footnotes: they affect how confidently readers can connect the posted estimate to the full trial conduct and prespecified analysis.

17. 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 posted outcome summary gives participant counts at a single primary time point, but it does not give individual measurements or the distribution of MDS-UPDRS III score changes. As a result, the direction and spread of changes within each arm cannot be examined, and the binary threshold result cannot distinguish modest from larger decreases among participants who met the cutoff.

The registry does not report baseline score summaries, demographic or clinical characteristics, or other details that would help describe the enrolled participants. It also does not provide the threshold-selection rationale, the full eligibility criteria, or the randomization procedure. The multicenter designation is stated, but the registry record does not describe the centers or provide center-specific results.

Interpretation is further limited by the absence of analysis details. The registry lists zero analysis entries and does not specify the methods behind the displayed confidence intervals and p-value. It does not report the analysis population, handling of missing outcomes, protocol deviations, or multiplicity procedures. The posted safety information is limited to counts, without event descriptions or detailed collection and follow-up information.

The primary comparison concerns the two-month assessment. Although the registry describes device use through month six, no later outcome results are posted. The record therefore does not describe the longer-term pattern of motor scores or outcomes after both groups were scheduled to receive an active device. These limitations concern the information available in the registry record; they should not be taken as proof that the unreported procedures or data do not exist elsewhere.

18. Related Tutorials

19. Related Statistical Calculators

20. Sources

• ClinicalTrials.gov: Evaluation of a Millimeter Wave Emission Bracelet for Improving Parkinson's Disease Symptoms — NCT04648150.
• Registry record last updated 2024-12-13; status last verified 2024-12.
• Results first posted 2024-12-13.
• 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.

21. Record Summary

NCT04648150 is a completed multicenter, double-blind randomized controlled trial of an active millimeter-wave emission bracelet compared with an inactive bracelet in Parkinson disease. The record lists 60 participants, with 30 in each group. Its primary endpoint was the number of participants with a decrease of at least 3.25 points on MDS-UPDRS III at two months after inclusion, assessed under ON Dopa conditions and blinded from the randomized group.

The posted counts meeting the endpoint were 6 in VERUM and 13 in SHAM. The risk difference was -0.233, with a confidence interval from -0.461 to -0.005, and the displayed unadjusted p-value was 0.052. The registry also lists risk-ratio and odds-ratio estimates with intervals. No secondary outcomes or analysis entries are posted. The original sample-size rationale, inferential methods, missing-data handling, and analysis population are not reported in the registry record.