Diagnostics & Imaging Week Associate

CLEVELAND — Within the promising early-stage realm of neuroscience, one area of particular interest for physicians, patients and investors is undoubtedly implantable neuromodulation devices.

Neuromodulation devices, which most often provide therapy via deep brain stimulation (DBS), are already providing successful — albeit limited — treatment for chronic pain, spasticity and movement disorders such as Parkinson's disease. And there are many more emerging applications for the therapy, including Alzheimer's disease, spinal injuries, intractable angina, headaches, epilepsy, depression, obsessive compulsive disorder, stroke and a host of other conditions.

Ali Rezai, MD, moderated a panel here, during the Medical Innovation Summit of the Cleveland Clinic (Cleveland, Ohio), to consider both the current and future applications of neuromodulation therapy that also featured a "who's who" of companies, big and small, that are actively pursuing neuromodulation programs.

Rezai, director of the Cleveland Clinic's Center for Neurological Restoration and director of its Brain Neuromodulation Center, said the neuromodulation market for medical devices is just seeing the "tip of the iceberg." Thus, he described the current state of the technology in the field as still very early stage, and "in my opinion [comparable] to where [we were] 25 to 30 years ago in cardiac devices — and needs to really develop further."

Rezai said that ultimately he sees medical devices utilized much earlier in the disease process for neurological conditions, perhaps in many cases even supplanting drugs.

"The concept of brain pacemakers is here to stay," Rezai said.

While neuromodulation is still in its adolescence, Chris Chavez, CEO of St. Jude Medical's (St. Paul, Minnesota) Advanced Neuromodulation Services (Plano, Texas) business, said it has already come a long way since its beginnings. "It's literally gone from being an invisible therapy to something that is on the verge of becoming mainstream," he said.

The neuromodulation business already accounts for a more than $1.5 billion business worldwide, Chavez said, adding, "it promises to be a multimodality, multibillion dollar business in the not-too-distant future."

The beauty of neuromodulation, he said, is that because it's targeted, one can reduce the dosage of stimulation, thereby reducing side affects. And he said that these devices will become smaller, be driven by longer-lasting batteries, have an increased level of efficiency and be available at greatly reduced cost.

"I genuinely believe that it is even impossible to imagine what this field will look like in 10 years," he said.

Richard Kuntz, MD, president of Medtronic's (Minneapolis) neurological business, said his company views the ultimate neuromodulation payoff "to be the targeted, regulated delivery of electrical stimulation or chemical compounds that really is not achievable by systemic administration. I think that this goes beyond neuromodulation itself."

Alan Levy, PhD, CEO of Northstar Neuroscience (Seattle), described how his company is using electrical stimulation on the cortex (outer layer of the brain) to treat a variety of conditions. Since its products are placed outside the brain and not used in DBS procedures, Levy noted that this makes them "fast, safe and easy to place." Additionally, since the cortex controls so many neurological functions, "it makes us able to treat many neurological conditions."

One area that the company is focusing on is chronic stroke. Each year 500,000 people in the U.S. survive a stroke and are told they have to live with the debilitating effects of it.

By stimulating neurons in new neuroplastic areas of the brain Northstar said plasticity and brain function can be "significantly" enhanced.

Northstar is also in the midst of a clinical trial to test the efficacy of cortical stimulation for treatment-resistant depression.

Discussing a technology for possibly repairing spinal cord injury with neuromodulation technology was Timothy Surgenor, president/CEO of Cyberkinetics Neurotechnology Systems (Foxborough, Massachusetts). Surgenor described a technology that uses an oscillating field stimulator (OFS) to entice nerve fibers to grow towards each other for spinal injuries.

A clinical study of acute spinal cord has shown promise, he said, and the FDA has designated the system as a candidate for a Humanitarian Device Exemption (HDE).

"We're planning to file for that [HDE] approval next quarter," Surgenor said.

Cyberkinetics is also exploring a completely different technology called the Braingate system which uses a Neuroport sensor to allow stroke patients who cannot speak or walk to remotely control devices, such as computers and wheelchairs, by using only their thoughts to direct the systems.

The company is also planning to use the Neuroport sensor as a therapeutic and diagnostic tool to study and predict epileptic seizures using specific circuits in the brain as opposed to the traditional method of studying generalized regions of the brain.

Surgenor envisioned for the attendees eventually combining the Braingate and OFS technologies to create a closed-loop system that would function much like a heating system that is regulated via a thermostat.

"One example of how these can be combined would be closed-loop devices that allow you to use the OFS technology to repair brain injuries or strokes and actually be able to measure their progress using the Braingate sensing technology."