Percutaneous direct current stimulation – a new electroceutical solution for severe neurological pain and soft tissue injuries

Abstract

There is a high medical need to improve the effectiveness of the treatment of pain and traumatic soft tissue injuries. In this context, electrostimulating devices have been used with only sporadic success. There is also much evidence of endogenous electrical signals that play key roles in regulating the development and regeneration of many tissues. Transepithelial potential gradients are one source of the direct current (DC) electrical signals that stimulate and guide the migration of inflammatory cells, epithelial cells, fibroblasts and mesenchymal stem cells to achieve effective wound healing. Up to now, this electrophysiological knowledge has not been adequately translated into a clinical treatment. Here, we present a mobile, handheld electroceutical smart device based on a microcontroller, an analog front end and a battery, which generates DC electric fields (EFs), mimicking and modulating the patient’s own physiological electrical signals. The electrical stimulation is applied to percutaneous metal probes, which are located close to the inflamed or injured tissue of the patient. The treatment can be used in an ambulatory or stationary environment. It shows unexpectedly, highly effective treatment for certain severe neurological pain conditions, as well as traumatic soft tissue injuries (muscle/ligament ruptures, joint sprains). Without EF intervention, these conditions, respectively, are either virtually incurable or take several months to heal. We present three cases – severe chronic cluster headache, acute massive muscle rupture of the rectus femoris and an acute ankle sprain with a ruptured anterior talofibular ligament – to demonstrate clinical effectiveness and discuss the fundamental differences between mimicking DC simulation and conventional transcutaneous electric nerve stimulation (TENS) or TENS-like implanted devices as used for peripheral nerve cord, spinal cord or dorsal root stimulation.

Keywords:

• electroceutical device
• tissue regeneration
• pain
• direct current stimulation
• electric field

Acknowledgments

We are grateful to the orthopedic MDs Lutz Neumann (case 2) and Andreas Graeb (case 3) for their contributions. We also thank Wolfgang Schumann for the critical reading of the manuscript and Harald Fischer for the technical description of the device.

Disclosure

Albrecht Molsberger is the CEO of the company, which builds the percutaneous DC stimulator (CHP GmbH). He holds one granted and several pending patents on the procedure. He has been receiving funding from the German government for the technical and clinical development of the treatment. Colin D McCaig has no conflicts of interest in this work.