CHICAGO – Placing an electrode pad on an open sore? Wrapping an electrical, pulse-producing brace around an arthritic knee? Using electrodes on the brain to wake up a severely brain-damaged patient? Which one of these is science fiction, which is hocus-pocus and which is for real?

Electromagnetic therapies have certainly been around for a while. The first pacemakers were developed in the 1950s and the first implantable pacemaker was introduced in 1960. For chronic pain, transcutaneous electrical nerve stimulation (TENS) has been FDA approved since the 1970s and works by suppressing pain signals to the brain. Several trends have driven growth in these technologies including:

1. Growing regulatory approval and reimbursement acceptance
2. Increasing acceptance of alternative medicine
3. Improved technology (in particular the miniaturization of electrical devices and improved software-driven intelligence of these devices)

Electromagnetic therapies like the pacemaker or TENS are relatively passive technologies that either create or interfere with existing electromagnetic processes in the body. While uses of this sort are part of mainstream medicine, “bioelectromagnetic” uses such as wound healing, arthritis healing and brain-injury rehabilitation fall outside the mainstream.

The concept of using electromagnetic signals in these ways to actually interact with and influence biological processes (“bioelectromagnetics”) is much more controversial. This application of electromagnetic therapy in actually modulating biological healing represents a brave and not entirely proven field.

In this more controversial area of bioelectromagnetics, one such therapy has been approved by the FDA: the use of pulsed magnetic fields to facilitate healing of non-union bone fractures. Even so, this also remains controversial and is not universally used. The therapy works by simulating a low-level electrical field generated by the body when a bone is broken.

Intensification of this signal is believed to augment and accelerate the healing process.

Transcranial magnetic stimulation (TMS) is another area that has gained currency if not FDA approval. TMS is approved for peripheral nerve use and sometimes is applied to central nervous system applications. TMS involves rapidly changing magnetic fields that are used to create weak electrical currents to excite neurons in the brain to potentially have long-lasting effects on their activity.

Let’s get back to the science fiction-sounding examples from above. Between wound healing, knee arthritis and brain injury, which one is for real?

Earlier this year, the FDA approved a wearable device – a wrap-around electromagnetic stimulation device in the form of a brace produced by Bionicare Medical Technologies –for the “transcutaneous electrical stimulation of arthritis”.

Unlike TENS (which mitigates the pain response), the Bionicare electrical signal is (as with fracture healing) believed to stimulate the actual healing process with improvements in pain indices and delaying of knee replacement surgery as a key outcome. A similar application is being developed for hand osteoarthritis.

How about wound healing and traumatic brain injury? The wound-healing application has not been approved by the FDA and most third-party payers have deferred reimbursement in the face of inconclusive evidence.

The brain injury example was the subject of an article in Monday morning’s New York Times, which reported on recent rather remarkable results of deep brain stimulation surgery in which electrodes were placed in a patient’s thalamus (an area of the brain known to interact with other areas) in order to stimulate widespread connections throughout regions of the brain.

The lead neurologist of the study – Dr. Nicholas Schiff of Cornell – noted a “consistent trend of improved verbal and behavioral responsiveness during the [electrode] on condition”. While the results appear exciting, ethical concerns (no doubt heightened by the checkered past of psychosurgery) and the technical demands of the surgery will make it unlikely that this treatment enters into mainstream use any time soon.

In addition, Northstar Neuroscience is developing an approach to brain-injury rehabilitation – stroke, in this case – that is mid-way between the non-invasive TMS approach and the highly invasive deep brain stimulation approach as reported by the Cornell team.

With the Northstar device, a cortical stimulator is placed on the surface of the brain that is then connected to a pacemaker-like (pulse generator) device implanted just over the shoulder. Clinical studies are under way and it will certainly be interesting to see if this intermediary approach can achieve sustainable results with minimal invasiveness.

The bottom line? Bioelectromagnetics is a rapidly growing area. Due to the complexity and complicating human factor of this technology, one can expect many failures. Even so, I believe the sheer diversity and range of applications will make electromagnetic approaches to therapy more mainstream over the years. Drug and device companies take note.