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tVNS UK

tVNS R for research

The programmable tVNS R research device for universities, ethics-approved studies, and specialist centres in the UK. Parameter control, sham mode, the Triggerbox, and UK support from Anatomical Concepts UK.

tVNS R for research

Who this page is for

This page is for research groups: universities, NHS research departments, and specialist centres running or planning an ethics-approved study of auricular vagus nerve stimulation. It describes the tVNS R, the programmable research version of the tVNS system from tVNS Technologies GmbH, and how to work with us to get one in the UK.

If you are a patient, a carer, or a clinician considering tVNS for a patient, this is not the device for you. The tVNS device is the certified therapy version, and the conditions pages and the clinician zone cover its use.

What the tVNS R is

The tVNS R uses the same stimulator platform and ear electrode as the therapy device, with the controls that a study needs and a home user does not.

  • Programmable parameters. Frequency, pulse width, intensity, and duty cycle are set through the research app, so a protocol can be specified and held constant across participants, or varied by arm.
  • Sham mode. A configuration for the control arm, so that blinding can be built into the device rather than improvised.
  • The Triggerbox. An accessory for closed-loop stimulation triggered from a physiological signal such as the ECG, for studies of cardiac-gated or event-related stimulation.
  • fMRI-compatible electrodes. For imaging studies of brainstem and cortical engagement during stimulation.
  • Session logging. Stimulation sessions are recorded for adherence and dose reporting.

The cymba conchae electrode placement is the same as the therapy device: the one region of the outer ear with purely vagal innervation, and the site used in the trials that underpin the therapy indications.

What the tVNS R is not

Two things are worth stating plainly, because they matter to ethics committees and to us.

  • It is not a clinical device, and we do not supply it to patients. The certified therapy device is the tVNS with its fixed 25 Hz protocol. A programmable device is for a protocol under a study's own governance, not for adjusting a patient's treatment outside the certified settings. We will not supply a tVNS R as a way around that.
  • It is not an adjustable version of the therapy device for clinical use. If a clinician wants to treat a patient, the route is the therapy device and the practice guide. If a clinician wants to study a question, the route is this page.

Regulatory position

The tVNS R is supplied for use in research under the governance of the study: ethics approval, sponsor oversight, and the protocol's own safety monitoring. When you enquire, ask us for the manufacturer's documentation you will need for your ethics application and your sponsor's device assessment. We will tell you what the device is certified for and what it is not, and we would rather you had that in writing before you write your protocol than after.

Anatomical Concepts UK is the UK Responsible Person for the tVNS device with the MHRA. Adverse events in a study follow the study's reporting route and, for device-related events, the MHRA Yellow Card scheme; we support both.

The evidence context

The therapy indications rest on trials of auricular stimulation at the cymba conchae, summarised in the clinician evidence library. Independently funded trials on the manufacturer's hardware are in progress in the UK and Germany: TRICEPS, an NIHR-funded trial of a movement-activated variant in chronic stroke across UK centres, and TRAVAST, a triple-blind trial in drug-resistant epilepsy commissioned in Germany. Both are independent of the manufacturer's funding, and we say so because it is a strength of the platform for a research buyer.

The evidence library is also candid about what the field still lacks: dose-optimised parameters, reliable predictors of response, adequately powered sham-controlled trials in some indications, and long-term data. If your study addresses one of those gaps, we want to hear about it.

Working with UK research groups

We would like the tVNS R to be in the hands of UK groups that will publish. That is not a slogan: UK clinicians who are asked about this device will look for UK references, and research is where those come from.

What we offer:

  • UK invoicing and supply. Purchase orders, VAT handling, and delivery inside the UK, so your finance office is not dealing with a German shop.
  • Protocol support. We know the parameter space the published trials used and where they differ. We are happy to talk through electrode placement, titration, sham design, and adherence measurement before you finalise a protocol.
  • Fitting and training. A session for your research team on electrode placement, the research app, and the Triggerbox, in person or by video.
  • Consumables. Electrodes, pads, rings, and cream supplied to the study on a schedule.
  • Placement terms for groups that will publish. Evaluation pricing or loan arrangements, agreed case by case with the manufacturer.

Pricing

Price on enquiry. Research pricing depends on the number of devices, the accessories the protocol needs, the duration of the study, and whether a placement arrangement applies.

How to enquire

Email info@anatomicalconcepts.com with "research" in the subject line, or call +44 141 628 8222 (Monday to Friday, 08:30 to 16:30). It helps if you can tell us:

  1. Your institution and the principal investigator.
  2. The study question and population, in a sentence or two.
  3. Ethics status: approved, submitted, or in preparation.
  4. How many devices, which accessories, and for how long.
  5. Your timeframe.

We will reply with the documentation you need, a quote, and, if useful, a call.

Contact Anatomical Concepts UK

Open the clinician evidence library

tVNS® is a registered trademark. The tVNS therapy device is a Class IIa medical device manufactured by tVNS Technologies GmbH, Germany. Distributed in the UK by Anatomical Concepts UK Ltd. The tVNS R is supplied for research use.