Developing Novel Customized Therapies

Defense Advance Research Projects Agency, Arlington, Virginia

The Defense Advanced Research Projects Agency (DARPA), Arlington, VA, is developing a new Electrical Prescriptions (ElectRx) program exploring neuromodulation of organ functions to help the human body heal itself.

Fig. 1 – Pictured are the concept and goals of the ElectRx program.

In nature, the body’s peripheral nervous system constantly monitors the status of its internal organs to regulate responses to infection, injury, or other imbalances. When this regulatory process is disturbed, due to injury or illness, peripheral nerve signals can exacerbate a condition, causing pain, inflammation, or immune dysfunction. Many difficult-to-treat conditions might be managed more effectively by precise modulation of the peripheral nervous system than by conventional medical devices or medications, the researchers said.

“The technology DARPA plans to develop through the ElectRx program could fundamentally change the manner in which doctors diagnose, monitor, and treat injury and illness,” said Doug Weber, DARPA program manager. “Instead of relying only on medication, we envision a closed-loop system that would work in concept like a tiny, intelligent pacemaker. It would continually assess conditions and provide stimulus patterns tailored to help maintain healthy organ function, helping patients get healthy and stay healthy using their body’s own systems.”

Minimizing Sensors and Risk

The goal of the ElectRx program is to develop new, high-precision, minimally invasive technologies for modulating nerve circuits to restore and maintain human health. ElectRx technologies are also expected to help accelerate scientific research aimed at achieving a more complete understanding of the structure and function of specific neural circuits and their role in health and disease. Potential targets include recently identified circuits involved in regulating immune system function, providing new hope for treating a range of inflammatory diseases, including rheumatoid arthritis, systemic inflammatory response syndrome, and inflammatory bowel disease. ElectRx is also expected to improve peripheral nerve stimulation treatments for brain and mental health disorders, such as epilepsy, traumatic brain injury, Post-Traumatic Stress Disorder, and depression.

Achieving these goals, however, would require new technologies for in vivo sensing and neural stimulation, including advanced biosensors and novel optical, acoustic, and electromagnetic devices to achieve precise targeting of individual or small bundles of nerve fibers that control relevant organ functions. (See Figure 1)

Simple implantable devices for management of chronic inflammatory diseases and other disorders are already in clinical use, and the market for neuro-modulation devices is growing rapidly. Current devices, however, are relatively large, require invasive surgical implantation and often produce side effects due to their lack of precision.

ElectRx seeks to create ultraminiaturized devices, approximately the same size as individual nerve fibers, which would require only minimally invasive insertion procedures such as injectable delivery through a needle.

DARPA expects to release a Broad Agency Announcement with full technical details on ElectRx in the coming months on the Federal Business Opportunities website ( www.fbo.gov ). Eventual participants would be required to obtain regulatory guidance from the FDA throughout all phases of the planned five-year program, culminating in approval of an FDA Investigational Device Exemption to enable pilot studies of ElectRx devices in humans. For more information, please e-mail This email address is being protected from spambots. You need JavaScript enabled to view it..