Remedius Ltd. found electrode shape and stimulation parameters significantly impact TENS therapy efficacy. TTP validated this with nerve activation modelling, showing dome-shaped electrodes improve outcomes, enhance safety, and extend battery life, giving Remedius a competitive edge in the neuromodulation market.
Context
Transcutaneous electrical nerve stimulation (TENS) is widely used for pain management, yet its efficacy remains inconsistent. Recent clinical evidence collected by Remedius ltd. suggested that the shape of the electrodes and stimulation parameters greatly affect therapy outcomes. Remedius aimed to scientifically validate these findings and understand the mechanisms driving improved efficacy.
Solution
TTP’s Neurotechnology team developed a computational model of nerve activation in subcutaneous tissue, enabling the evaluation of TENS therapy effectiveness under various electrode geometries and stimulation configurations.
Result
TTP’s analysis demonstrated that dome-shaped electrodes greatly enhance pain therapy outcomes compared to flat patch electrodes commonly used in TENS devices and revealed potential underlying mechanisms of this behaviour. In addition, new electrodes operate at lower device currents, which extends battery life and enhances safety for patients. These results will offer Remedius a robust scientific foundation to differentiate their product in the competitive neuromodulation market.
Transcutaneous electrical nerve stimulation through computational modelling
Remedius Ltd., a company pioneering innovations in neuromodulation for pain management, sought to enhance Transcutaneous Electrical Nerve Stimulation (TENS) therapy by replacing flat electrodes with dome-shaped alternatives. Their preliminary clinical evidence indicated substantial benefits, but they needed robust scientific validation to confirm the mechanisms behind these improvements and subsequently support their regulatory submission.
To address this, Remedius engaged TTP’s Neurotechnology team, leveraging our expertise in neuromodulation and multi-physics computational modelling. TTP’s deep technical understanding and agility allowed us to move swiftly and deliver results at a fast pace.
Our Approach
We developed a comprehensive 3D finite element model simulating the electrical fields (E-fields) generated by TENS devices across cutaneous and subcutaneous tissues. The model incorporated an active nerve fibre simulation based on a modified Hodgkin-Huxley framework to determine activation thresholds for Aβ, Aδ, and C nerve fibres at varying tissue depths.
The simulations compared the performance of dome-shaped electrodes against conventional flat patch electrodes, evaluating factors such as E-field strength, nerve activation depth, and device current required for nerve activation.
Conventional TENS electrodes compared to Dome-shaped electrodes
Results
Within five weeks, we delivered a detailed report confirming the superiority of dome-shaped electrodes and gained insight into the mechanisms that contribute to their advantage:
- Dome-shaped electrodes generated stronger E-fields and activated nerves at significantly lower device currents.
- At equal currents, dome-shaped electrodes achieved four times the nerve activation depth and 40% greater E-field coverage.
- Large nerves at depths of up to ~1 cm could be activated using safe currents below 30 mA, compared to traditional flat electrodes, which were limited to depths less than 0.25 cm.
This evidence underscores the enhanced therapeutic efficacy, safety and energy efficiency of dome-shaped electrodes, enabling longer battery life as well as improved pain relief.
Threshold currents for activation of Aβ and C fibres
Impact
TTP’s findings provided scientific validation that complements Remedius’ clinical data, strengthening their case for regulatory submission. Building on this success, the next step for TTP will involve supporting design verification testing and leveraging our quality-controlled manufacturing capabilities to help accelerate Remedius’ path to regulatory approval, in support of its product launch objectives.
From the outset, TTP demonstrated a deep understanding of our complex scientific concept and provided an elegant solution to our problem with impressive speed. Their vast knowledge, coupled with access to allied specialities, made them stand out as a multidisciplinary powerhouse.
About TTP's Neurotechnology team
From proof-of-concept studies to manufacturing scale-up, TTP's dedicated neurotechnology consulting services can help you rapidly engineer advanced neuromodulation solutions, guiding you every step of the way. With our multidisciplinary team of engineers, scientists and human factors designers, you can hit the ground running. Combining deep expertise with a proven track record in end-to-end product development, we will help you create technologies and devices that push the limits of what's possible in neurotechnology. Find out how our neurotechnology consulting team can help you start strong and finish ahead.
TTP's Neurotechnology product development team is part of a broader MedTech team. Learn more about TTP's approach to medical device design and development and our medical device consulting services.
