Applicability
Scope and limitations
This page sets out the criteria used to determine whether Verada instrumentation is applicable to a given intervention, the categories in which the case is currently established, those in which it remains unresolved, and those in which measurement would not be informative. The criteria are published so they can be applied independently of us.
Stage determines which categories of evidence remain collectable
Regulatory status is the most consequential variable, because it determines what can still be generated. Randomisation, a pre-exposure baseline, blinded assessment and a pre-specified primary endpoint are available only during study design and cannot subsequently be reconstructed. Operational and health-economic evidence has the opposite property: it requires a service in routine delivery and cannot be produced in advance of one.
Approved, with limited adoption
A CE, UKCA or FDA-cleared technology in established use in other health systems and without meaningful UK or US deployment. Efficacy is not the limiting factor; the constraint is the absence of local operational and economic evidence, which cannot be generated without a provider willing to deploy the technology first.
- Evidence required: utilisation and throughput, staffing and training burden, completion and attrition, cost and revenue per session, and payback period
- Mechanism: deployment into Verada care delivery at Verada commercial risk, with the resulting operational and economic data published
- Time dependency: none absolute, though adoption evidence accrues only from the point of first deployment
Under investigation, endpoints not yet fixed
A device, small molecule, biologic or advanced therapy in development, where the endpoint architecture remains open and assessment frequency is constrained by participant travel to study sites.
- Evidence required: objective endpoint capture at a sampling density sufficient to characterise a trajectory rather than two timepoints
- Mechanism: instrumented delivery in the participant environment, with all four clinical outcome assessment types recorded against a single participant timeline
- Time dependency: absolute. Randomisation, baseline, blinding and endpoint pre-specification are not retrospectively recoverable
Most technologies traverse both stages. Where the same instrumentation, population and data infrastructure are retained across the transition, the resulting record is continuous from pre-exposure baseline through to a reimbursement decision, which is not achievable where the two phases are contracted to different providers.
Three conditions, applied conjunctively
Applicability is assessed against the following conditions, all of which must hold. The framework constrains the assessment to mechanism rather than diagnostic category, which would otherwise admit any condition with a neurological or musculoskeletal component.
Principal failure mode. Inference from diagnostic category rather than from mechanism. A condition may be neurological in classification while its therapeutic target lies outside the cortical and neuromuscular pathway, in which case condition three fails irrespective of how the indication is described.
Two devices, recording different physiological layers
Applicability follows from mechanism rather than therapeutic area. The two devices are not interchangeable and address different axes.
Paired EEG and surface EMG
Simultaneous recording of cortical state and neuromuscular control during upper-limb activity, permitting expression of the coupling between them.
- Records: scalp EEG at standard 10-20 positions and surface EMG across defined forearm and hand muscle groups, time-aligned
- Applicable to: neurological and CNS interventions in which cortical engagement forms part of the mechanism of action
- Not applicable to: mechanisms acting outside the cortical to neuromuscular pathway. Recording is limited to the upper limb
Surface EMG with joint mobility
Muscle activation, recruitment pattern, symmetry, co-contraction and fatigue indices, recorded alongside active range of motion at any major muscle group or joint.
- Records: surface EMG with simultaneous range of motion, resolved per muscle rather than as an aggregate index
- Applicable to: a substantially wider anatomical range, including regions conventionally assessed by strength testing, timed function tests or imaging
- Not applicable to: questions concerning cortical state, which this device does not record
Verada operates as a measurement layer
Efficacy claims arising from any study Verada supports remain with the sponsor. This holds including where a device manufacturer is separately pursuing a therapeutic indication for the same instrument.
Category A: the recorded axis coincides with the therapeutic target
In the following categories the instrumentation records the physiological layer on which the intervention acts, rather than a downstream consequence of it. The measurement is therefore direct rather than proxy.
Neuromodulation & rehabilitation devices
Brain-computer interfaces, functional electrical stimulation, robotic rehabilitation, transcranial stimulation, paired neurostimulation, neurofeedback. These act directly on cortical excitability and brain-muscle coupling. Cleanest mechanistic fit on the map.
Cell, gene & advanced therapies
Neuro-restoration in stroke, TBI and neurodegeneration. Large functional-restoration claims on very small participant numbers, graded on the motor scales that drift most. Rater noise a large trial averages out is fatal to a forty-patient study.
Recovery & antispasticity pharmacology
Plasticity-enhancing agents, botulinum toxin and antispasticity drugs. These are dosed precisely to change agonist-antagonist balance and co-contraction, which is exactly what the instrument quantifies. The measurement is of the intended effect, not a downstream proxy.
Category B: the recorded axis is secondary to the therapeutic target
In these categories the measurement addresses a real and often under-instrumented dimension that is not the primary efficacy target. Two entries compete with established tools rather than addressing a gap, and are labelled accordingly.
Antipsychotics & psychiatry
Drug-induced parkinsonism, akathisia and tardive dyskinesia. The motor signal moves adversely with the drug, which is precisely why it is measurable. The vulnerability in current scales is that they are episodic and clinic-based, not that raters are incompetent.
Cognition-targeting CNS drugs
Schizophrenia cognition, mild cognitive impairment and dementia assets. Cognitive batteries carry well-documented ceiling and practice effects and systematically omit the motor dimension. We supply what the battery misses rather than replacing it.
Movement disorders
Validated motor scales and actigraphy already exist here and are well established. Claiming superiority as a motor quantifier would invite immediate and deserved pushback. The defensible wedge is cognitive-motor coupling and between-visit home capture, which the incumbents do not address.
Multiple sclerosis
The functional and cognitive-fatigue layer only. Disability scales capture that layer coarsely and fatigue is under-instrumented relative to its impact on daily life. We say nothing about the immunological disease activity the drug actually modifies.
Categories in which the incumbent measure is a strength test, questionnaire or static scan
Surface EMG with range of motion is a less complex measurement than paired cortical and neuromuscular capture, with a correspondingly lower analytical validation burden and a wider anatomical range.
Musculoskeletal & orthopaedic
Knee and shoulder arthroplasty, ligament reconstruction, frozen shoulder, back and paraspinal dysfunction. Imaging shows structure; this shows whether the muscle around it is actually working, and which one is compensating.
Orthobiologics & injectables
Platelet-rich plasma, biologic and regenerative injection. The biological effect is invisible; the functional recovery is not. Baseline before injection, then interval reassessment against it, gives an objective recovery trajectory where the usual endpoint is a pain score.
Sarcopenia & muscle preservation
Grip strength does not say which muscle. Chair-stand is confounded by balance and pain. Imaging gives mass, not function. For any intervention intended to preserve or restore muscle, including alongside therapies that cause lean mass loss, activation and recruitment are the layer the incumbent measures miss.
Pelvic floor
Continence and pelvic floor rehabilitation, including after prostate surgery or radiotherapy. Training is standard care and adherence is largely unverifiable, because neither patient nor clinician can see whether the right muscle contracted. Biofeedback makes an invisible muscle group measurable.
Respiratory muscle function
Diaphragm and accessory muscle activation in pulmonary rehabilitation, obstructive and restrictive lung disease, and recovery of respiratory strength after critical illness. Spirometry measures the output; this measures the muscle producing it.
Cerebral palsy & spasticity management
Spasticity, co-contraction and selective motor control. Incumbent measures are ordinal spasticity scales with documented inter-rater variability. Botulinum toxin and antispasticity agents are titrated specifically to alter agonist and antagonist balance, which is the quantity the instrumentation records directly rather than through a graded clinical impression.
Neuromuscular disease
Muscular dystrophies, spinal muscular atrophy and related disorders. Gene, antisense and enzyme therapies making large functional claims on very small participant numbers, graded on timed function tests and observer-rated motor scales that are effort-dependent and prone to ceiling. Muscle activation is the layer the therapy is trying to change. This is also the clearest case for paired capture, described below.
Oncology supportive care & survivorship
We cannot measure a tumour. We can often measure what treating it leaves behind: pelvic floor dysfunction after prostate treatment, shoulder restriction after axillary surgery, radiation fibrosis, treatment-related deconditioning, and the functional impact of chemotherapy-induced neuropathy.
Note on population. Two of these categories are wholly or predominantly paediatric. Paediatric research carries distinct consent, ethics and device-suitability requirements, and would not be undertaken as a first engagement.
Known dependency. For clinical use, this device reports in graded ordinal bands, which is appropriate for clinical interpretation. For use as a trial endpoint it is not, since a banded output reintroduces the ordinal ceiling characteristics that an objective measure is intended to remove.
Sponsor-facing deployment therefore requires access to the continuous underlying values with structured machine-readable export, rather than the clinical report layer. This is under discussion with the manufacturer and its status would be disclosed before protocol design.
Separating central from peripheral contribution to reduced output
In several conditions, reduced functional output may originate centrally, peripherally, or from both, and measures of output alone cannot discriminate between them. Simultaneous recording of cortical drive permits expression of output per unit of drive, a quantity with a more specific mechanistic interpretation than output measured in isolation.
On effort as a confound. Timed function tests, strength measures and most motor scales are effort-dependent: variation in participant motivation or fatigue on the assessment day propagates directly into the score. Simultaneous recording of cortical drive renders that variation observable rather than requiring it to be treated as unexplained variance.
Limitations. Paired recording is currently restricted to the upper limb. Where the clinically meaningful endpoint is ambulatory or respiratory, the measure supplements rather than substitutes for the primary. The relationship between cortical drive and muscle output is a hypothesis requiring establishment per condition and per intervention; it is at present exploratory rather than a validated readout.
Conditions one and two satisfied, condition three not established
The following categories present a credible measurable axis and a demonstrably limited incumbent endpoint, but no published evidence that the recorded signal covaries with therapeutic effect rather than with the presence of the intervention. They are listed as unresolved rather than omitted.
Attention & executive function
Cortical markers in attention disorders have an extensive literature, and incumbent endpoints are parent and clinician rated, so conditions one and two hold. Condition three does not: stimulant medication alters cortical activity independently of clinical response, and reported effect sizes in the diagnostic literature have attenuated as methodological quality has improved. Deployable as an exploratory measure; not presentable as a validated endpoint.
Cognitive-motor coupling in neurodevelopmental conditions
Where an intervention acts on the coupling between cortical state and motor control, the measurement is applicable in principle. Whether it is informative is intervention-specific. In paediatric and neurodevelopmental populations, consent and research ethics requirements are substantial and independent of the measurement question. Assessed individually.
On qualification. Formal qualification of a clinical outcome assessment is granted against a defined context of use, comprising a specified measure, concept of interest, population and role within the endpoint hierarchy. It does not constitute general acceptance of a signal. Qualification therefore accrues narrowly, and evidence generated by exploratory deployment in one indication does not transfer to another without a separate submission.
Categories in which the criteria are not satisfied
The following fail one or more of the conditions above for reasons that are structural rather than provisional. They are listed so that the preceding categories can be interpreted against a defined boundary.
Exclusions are defined by mechanism, not by therapeutic area. Tumour response is not recordable by this instrumentation; functional impairment arising from oncological treatment frequently is, and constitutes a distinct and under-instrumented endpoint. The relevant question is therefore which axis the intervention acts upon, not which specialty it belongs to.
- No fitTumour biology as the endpoint. Response, progression and survival lie outside the recorded axes.
- No fitImmunological targets, including disease activity in demyelinating disease. The mechanism of action lies outside the recorded axes; condition three fails.
- No fitPeripheral pain as a primary endpoint. Neurological in classification, but the mechanism is not on the recorded axis.
- No fitSeizure and epilepsy therapeutics. A distinct electroencephalographic question requiring different instrumentation, montage and interpretation. A history of EEG abnormality is also a contraindication for the devices in use.
- No fitCognitive performance enhancement in healthy populations. Not undertaken in any form. Where capacity to consent is itself affected by the condition under study, applications are declined on research ethics grounds independently of the measurement case.
- No fitAny application in which the signal is present in the population but does not covary with treatment effect. Presence of a measurable signal is not sufficient for condition three.
Further exclusions are maintained on research ethics grounds and are not subject to commercial assessment.
Applicability and operational capacity are separate
The preceding sections describe where the instrumentation is applicable. They do not describe current operational capacity, and the distinction is material to anyone planning a study.
Information required for an applicability assessment
The following five items are generally sufficient to reach a determination. None requires disclosure of confidential material. A negative determination is returned at first contact rather than after extended engagement.
Enquiries
Development stage, mechanism of action and current primary endpoint are sufficient for an initial determination. Where the criteria are not met, that assessment is returned promptly.
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