Aurorus / The Record / Frontiers

The Missing Instrument in Energy Medicine Research

Fields do not become sciences because someone finally believes them. They become sciences when someone finally builds the instrument that can tell whether they are true.

Fever was a symptom for two thousand years before it became a number. Physicians could see that a patient was hot, flushed, delirious — and they argued about what it meant, because argument was all they had. The clinical thermometer did not resolve those arguments by taking a side. It resolved them by producing a value that two observers could obtain independently and compare. Hypertension was invisible until the sphygmomanometer made it a quantity. Sleep was a single undifferentiated state until the EEG cut it into stages. In each case the phenomenon was there the whole time. What arrived was the ability to observe it in a form that could be written down, replicated, and disagreed with productively.

Energy medicine, intention-based practice, and much of the broader biofield category have not had that moment. This is the central reason the literature reads the way it does.

The endpoint problem

Look closely at what most studies in this category actually measure. Overwhelmingly, the primary outcome is a self-report instrument: a visual analog pain scale, a state anxiety inventory, a fatigue questionnaire, a wellbeing index. These are legitimate tools. They are also, for this particular research question, close to the worst possible choice — for three reasons that compound each other.

First, self-report is exquisitely sensitive to expectation. A participant who has just spent twenty minutes receiving warm, focused, unhurried attention from a practitioner will report feeling better. That is a real effect, and a well-documented one, but it is not evidence about the mechanism under investigation.

Second, self-report is low resolution. A seven-point scale cannot detect a small physiological shift, and small is precisely what any plausible effect in this domain would be. A study powered for a large effect on a coarse instrument will return null results whether the effect is absent or merely modest.

Third, and most damagingly, self-report endpoints cannot be blinded from the thing that matters. The participant knows whether someone was standing over them. You can sham the practitioner; you cannot easily sham the experience.

The consequence is that a genuinely null result and a genuinely real result produce similar-looking literature: a scatter of small, underpowered, unreplicated positive findings, methodologically criticized on arrival, followed by larger and better-controlled studies that find nothing, followed by a stalemate in which each side reads the same evidence as confirmation. That is not a controversy about the phenomenon. It is a controversy about the measurement.

What an adequate instrument would have to do

Before asking whether anything is there, it is worth specifying what a tool would need to be capable of in order to find out. At minimum:

  • Sensitivity on the right timescale. If an intervention lasts twenty minutes, the endpoint must be capable of resolving change across twenty minutes, not across weeks.
  • Test-retest reproducibility. The instrument’s own variability must be characterized and small enough that a real signal could be distinguished from measurement noise. Without this number, no change score is interpretable.
  • Operator independence. Two technicians, two sites, and two sessions should produce comparable values. Otherwise the study is measuring the technician.
  • Agnosticism. The instrument must not know, and must not be able to infer, which experimental arm a participant is in. It should produce the same computation regardless of what was done beforehand and regardless of what the investigator hopes to see.
  • Low burden and non-invasiveness. Blood draws and imaging suites limit sample size and repeated sampling. A measurement you can take four times in an afternoon is a different research tool than one you can take once.

None of these requirements are exotic. They are the ordinary specifications of any physiological endpoint. The point is simply that the biofield literature has largely proceeded without an endpoint that meets them, and has then been criticized — fairly — for producing weak evidence.

What Aurorus measures

The Aurorus platform is a non-invasive electrophysiological measurement device. It applies a field to tissue and captures the resulting optical emission, computing from it more than two dozen mathematical coefficients that describe the signal at segmented, whole-image, and aggregate levels. It is fast, repeatable, requires no consumables, and imposes essentially no burden on the participant. Across roughly three decades of platform use, it has produced more than 1.5 million scans across more than 750,000 individuals.

That is an energy measurement, and there is no reason to be coy about it. Electrophysiology is the measurement of energy in living systems — that is what the term means. An ECG measures the electrical energy of cardiac depolarization; an EEG measures the electrical energy of cortical activity. The category is more than a century old and entirely uncontroversial. What distinguishes instruments within it is which energetic phenomena they capture, at what resolution, and with what reproducibility.

What Aurorus captures is the tissue’s electrophysiological response to an applied field, expressed as optical emission. The physics is ordinary — charge transfer, dielectric behavior, photon emission — and so is the biology generating it. Mitochondrial respiration is the cell’s energy conversion machinery. Oxidative stress describes electron transfer running unbalanced. These are energy processes in the strict thermodynamic sense, not the metaphorical one.

What we can say about the relationship between those processes and our signal is worth stating with some care, because the honest version is more useful than the strong one. In a prospective, single-center study of 353 subjects conducted at Greater Baltimore Medical Center, with the research staff masked to participants’ diagnoses, the platform’s output discriminated the presence of cardiovascular disease independently of other conditions.[1] Cardiovascular disease is a condition in which mitochondrial dysfunction and oxidative stress are established contributing factors. A signal that tracks it is carrying information related to the processes that drive it, and that constrains what the instrument can be doing.

It is not a direct assay of mitochondrial respiration, and we have not run one. Measuring respiration directly is invasive enough to be impractical in the populations and settings this platform is built for — which is much of the reason a non-invasive proxy is worth having in the first place. A head-to-head validation against an established respirometry method is the study that would close that gap, and it has not been done. Until it is, the accurate description is that the instrument measures an electrophysiological signal that correlates with disease states of known mitochondrial and oxidative origin, and that the mechanistic link is a well-motivated hypothesis rather than a demonstrated one.

That is a narrower claim than “we measure mitochondrial function,” and it is the one that survives contact with a skeptical reader. It is also, not incidentally, the claim that a properly designed validation study could upgrade.

The precision is what does the work. “We measure energy” invites every reader to supply their own meaning, and some will supply one we did not intend. “We measure the optical emission produced by tissue under an applied field, resolved into a defined coefficient set, reproducible to within a characterized tolerance” does not. The first is a claim about a category. The second is a claim about a measurement, and only the second can be checked by someone who doubts it.

Which is the point. The instrument produces numbers with units and error bars. Whether those numbers move reliably in response to a given practice is an empirical question, and not one we have any standing to settle by assertion — that is what the study designs described across this series are for. The instrument’s contribution is not that it proves anything. It is that it makes the question answerable.

What changes

If a sensitive, reproducible, agnostic endpoint is available, several things become possible that were not possible before.

A study can be blinded where it matters — at the level of the analyst and the data, even where the practitioner cannot be blinded. A study can be adequately powered, because a continuous, low-noise measure requires far fewer participants than a coarse ordinal scale. A study can pre-register a primary endpoint and be held to it. And critically, a study can produce an informative null. Under the current state of the field, a null result means very little, because the instrument was probably not capable of detecting the effect in the first place. With a characterized instrument, a null result is evidence.

That last point is the one we care most about. A field that cannot fail cannot be taken seriously. The value of a good endpoint is not that it will vindicate anyone — it is that it makes vindication and refutation both possible, which is the entry fee for being an object of scientific study at all.

The remaining posts in this series work through what a proper study design would require, why an instrument with an opinion about the answer would be a defective instrument, and what specific phenomena might be tractable first. None of them argue that these therapies work. They argue that the question deserves a real answer, and that the reason it has not received one is fixable.

[1] Rizzo NR, Hank NC, Zhang J. Detecting presence of cardiovascular disease through mitochondria respiration as depicted through biophotonic emission. Redox Biology. 2016;8:11–17. doi:10.1016/j.redox.2015.11.014. Open access. Published under a prior commercial name of the platform — see About the platform.

Regulatory note: Aurorus is a non-invasive electrophysiological measurement platform. It was granted FDA De Novo classification (DEN150004) as a Class I non-invasive electrophysiological measurement device. It is not cleared for diagnostic purposes. Nothing in this article claims that any therapy, modality, or practice diagnoses, treats, cures, or prevents any disease.

End · 7 min
Nancy Rizzo
Nancy Rizzo Prior to developing the science and technology for Aurorus, Nancy spent 13 years at Mayo Clinic Scottsdale as a board certified radiological therapeutic physicist and cochaired the Complementary and Alternative Medicine program. Nancy is board certified as a Radiological Therapeutic Physicist by the American Board of Radiology (DABR) and holds a Ph D. in Energy Medicine with an emphasis on Biophysics from Holos University.

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